To assess the efficacy and safety of subcutaneous methylnaltrexone in patients with advanced illness and opioid-induced constipation (OIC), and to clarify whether a dose-response relationship could be identified.

Methylnaltrexone was administered in doses of 1 mg, 5 mg, or 12.5 mg subcutaneously; patients were randomized to those dose groups in a ratio of 1:1:1. After 22 patients, the dose range was extended to 20 mg; patients were randomized in a ratio of 1:1:3 to 1-mg, 12.5-mg, or 20-mg dose groups. Patients received study medication if they had no bowel movement for at least two days and had a score of 3 or higher on a 5-point scale assessing constipation-related distress. Patients receiving laxatives had to be on a stable regimen for at least four days and remain on regimen during the study.

During the first week of the study, subcutaneous injections were administered on days 1, 3, and 5. Following the first week of double-blind study, patients received the option for open-label study for a maximum of three weeks. The initial dose was 5 mg subcutaneously as often as every other day. The maximum dose was 15 mg in the first 22 patients and 20 mg for the remaining 11 patients. Dose could be increased or decreased by the investigator.

• The study reported on a sample of 33 adult men and women (39 screened) with advanced illness, including patients with cancer receiving palliative care and chronic opioid therapy for pain.
• Mean patient age was 61 years (range 20-87). 
• Mean body weight was 64 kg.
• Seventy-nine percent of patients were Caucasian.
• Eighty-five percent of patients had a primary diagnosis of cancer.
• Eighty-five percent of patients used laxatives at baseline, 33% used stool softeners or emollients, and 27% used osmotic agents. 
• Patients were included in the study if they were receiving opioids, were stable for two weeks, and remained stable for four weeks; had no bowel movements despite conventional laxative therapy; had a life expectancy of at least four weeks; and had stable vital signs.

Multi-center

This randomized controlled, parallel-group, repeated-dose, dose-ranging trial included a double-blind phase for one week followed by an open-labeled phase for a maximum of three weeks.

• The primary endpoint, laxation response, was a bowel movement within four hours of the initial dose.
• Subjective outcomes were obtained prior to each dose and approximately three hours postdose.
• Constipation severity and distress were graded on a five-point categorical scale.
• The Opioid Withdrawal Scale was a modified Himmelsbach scale.
• Patient satisfaction was assessed on a seven-point scale.
• The severity of opioid adverse events were graded on a four-point categorical scale.

Twenty-two patients completed the blinded phase, and 14 completed the open-label phase.

In the blinded phase, laxation occurred within four hours on day 1 for 1 of 10 patients (10%) in the 1-mg dose group, 3 of 7 patients (43%) in the 5-mg dose group, 6 of 10 patients (60%) in the 12.5-mg dose group, and 2 of 6 patients (33%) in the 20-mg dose group. On day 2, for all dose groups higher than 1 mg, 11 of 23 patients (48%) responded (p = 0.05). There was no dose-response relationship across the three highest doses compared to the 1-mg dose.

The median time to laxation was higher than 48 hours for the 1-mg dose group and 1.72, 0.48, and 6.75 hours in the 5-, 12.5-, and 20-mg dose groups, respectively. The median time to laxation was 1.26 hours for all patients dosed 5 mg or higher, and was statistically significant compared to the 1-mg group (p < 0.0003). The 1-mg dose group required laxative rescue approximately twice as often as other groups. There was no trend in worsening pain control over time.

In the open-label phase, the response rate was from 49% to 64% for patients in dose groups from 5 mg to 12.5 mg. Secondary outcomes were not evaluated because of the small sample size.

Methylnaltrexone doses of 5 mg or higher in patients with advanced illness relieved OIC without decreased analgesia or withdrawal symptoms.

• The sample size was small (fewer than 100 patients).
• The drop-out rate was high: 11 of 22 patients withdrew during the double-blind phase, 4 declined the open-label phase, and 4 withdrew from the open-label phase.

To obtain information about the dose response for analgesia and safety in a population with medical illness and pain that is inadequately controlled by an opioid

Patients were randomly assigned to different-dose groupings of nabiximol or placebo delivered as an oral spray. Study design included a 5- to 14–day baseline period, five weeks of treatment titration, and a poststudy follow-up after two weeks. Patients received a daily call, from a voice recording system, that asked them to grade average pain. Patients continued the use of scheduled opioids and usual analgesics for the treatment of breakthrough pain. Patients who received at least one dose of the study drug were included in intent-to-treat analysis.

• The sample was composed of 263 patients.
• Mean patient age was 58 years. Age range was 20–93 years.
• Of all patients, 51.7% were male and 48.3% were female.
• Patients had active cancer and moderate to severe chronic pain despite opioid titration. Of all patients, 15% had breast cancer, 17.8% had gastrointestinal cancer, 17.8% had lung cancer, 12.2% had prostate cancer, 33.9% had some other cancer, and 3.3% had an unknown type of cancer.
• Patients were excluded if they had a major psychiatric or cardiovascular disorder, epilepsy, or significant renal or hepatic impairment or if they were pregnant, lactating, or used inadequate contraception. Also excluded were those expecting to receive therapies that would change pain and patients who were currently using or had used marijuana, cannabinoid-based medications, or rimonabant within 30 days of study entry and were unwilling to abstain for the duration of the study.

• Multisite
• Eighty-four study centers across North America, Europe, Latin America, and South Africa
   

• Phases of care: multiple phases of care
• Clinical applications: end-of-life care and palliative care
   

Randomized placebo-controlled, graded-dose trial

• Data obtained in response to six daily questions delivered via interactive voice-recording system
• Brief Pain Inventory (Short Form) (BPI-SF)
• European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30) Version 3.0
• Patient Assessment of Constipation Quality of Life (PAC-QOL)
• Montgomery-Asberg Depression Rating Scale (MADRS)
   

• Analysis of continuous responder rate favored the nabiximols groups (P = 0.035). However, this analysis was significant in the lower-dose groups only.
• The adjusted mean change in pain score for the low-dose group favored nabiximols (P = 0.006).
• Post hoc analysis that combed the low- and medium-dose groups showed a treatment difference in favor of nabiximols (P = 0.019). When weekly mean scores of average pain were compared across the groups, the low-dose group showed the greatest reduction, favoring nabiximols (P = 0.024).
• Sleep disruption scores were comparable at baseline for all groups. When evaluated at the end of treatment, the significant treatment effect (P = 0.012) was attributed to the low-dose group (p = 0.003). 
• The EORTC QLQ-C30 showed that nabiximols negatively affected cognitive functioning. In addition, compared to patients using placebo, patients using nabiximols experienced a significant amount of nausea and vomiting (P = 0.019). Authors noted that most nausea and vomiting occurred in the high-dose group (P = 0.0090).
• Of nabiximol-treated patients, 29.5% experienced a serious adverse event. Of placebo-using patients, 24.2% experienced a serious adverse event.

Nabiximols can be beneficial in the treatment of the refractory pain of patients with cancer. This study represents a start in regard to discovering the optimum dose effect and safety of nabiximols. In this study, low to medium doses were associated with the greatest effect.

• The study lacked dose individualization; therefore, the study cannot provide the most accurate picture of analgesic efficacy or side effects.
• The opioid-sparing effect could not be evaluated.
• Investigators might have avoided adverse events by lowering the dose of opioid.
• Reporting regarding sleep disruption could have been stronger if the study had used a validated tool.
• Authors provided no analysis of differences regarding breakthrough pain or total opioid doses between groups.
• According to the authors' power calculations, the study was underpowered and intention-to-treat analysis using last result forward could have had over- or underestimated effects.

This study affects nursing by providing a potential treatment option for patients with opioid-refractory pain. Nurses should be able to recognize opioid-refractory patients. Nurses should be educated regarding this novel cannabinoid treatment, its administration, and its side effects. Nurses should be able to teach patients how to use nabiximols. 

The study was conducted to evaluate the need of patients with breast cancer for neuropsychological rehabilitation after adjuvant chemotherapy. It also sought to determine the effectiveness of differentiated training programs after completion of treatment.

Participants were randomly assigned to one of two intervention groups. Control participants were selected from the “time-out” phase of the study when no training was being offered.

Both intervention groups took part in four one-hour training sessions per week during their inpatient stay. Participants were randomized to one of the following outpatient interventions.

1. Neuropsychiatric Training Group (NPT). A maximum of eight participants met with a specialized occupational therapist to work on improving attention and memory through situations specifically designed to reflect the demands of everyday life. They received practice in compensational strategies and specific techniques to improve their performance in these everyday situations, and reflected on their personal experiences.
2. Computer-based training (PC). Participants received individualized computer-based training with continuous therapeutic supervision. The software addressed specific attention and memory dimensions in eight modules. Following the PC training, participants also received individualized coaching according to their specific impairments.

Measures were completed upon admission to the rehabilitation unit (T1), at the end of in-patient rehabilitation (T2), and six months later on an outpatient basis (T3). 

• The number of participants was 90.
• All participants were female.
• All participants had breast cancer, with an average of 9.01 months since diagnosis and 2.06 months since the conclusion of chemotherapy.
• There were 33 participants in the NPT intervention group, 32 in the PC intervention group, and 25 in the control group.
• The average participant age was 49.19 ± 7.71 years.
• 16.7% of participants had a university degree, with only 3.1% not professionally trained.
• Participants were predominately receving chemotherapy with anthracyclines; most had postoperative localized radiation therapy and adjuvant antihormonal therapy.
• Individuals were exclused from the study if they were older than 64 years; had psychiatric mental health disorders or other cancer, psychiatric, or neurologic problems; or were currently using psychoactive medications.

The study took place at the Tumor Biology Center Rehabilitation Unit in Freiburg, Germany.

The study utilized a randomized, controlled trial.

• Questionnaire of Self-Perceived Deficits in Attention (FEDA) for attention
• Test Battery for Attentional Performance (TAP) for attention
• Digit Span for attention
• Wechsler Memory Scale-Revised for memory
• Rivermead Behavoral Memory Test (RBMT) Immediate and Delayed Story Recall for memory
• Learning and Memory Test (LGT-3) for memory
• Multidimensional Fatigue Inventory (MFI) for mental fatigue, activity, and motivation
• Hospital Anxiety and Depression Scale (HADS) for anxiety and depression
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - 30 (EORTC QLQ-30) for global and functional quality of life. The EORTC QLQ-30 uses six subscales (global, physical, role, cognitive, emotional, social functioning). Scores range from 0–100, with higher scores indicating higher quality of life.

No intervention effects were noted in this study. Significant improvement was noted in 11 of 16 neuropsychiatric parameters for all three groups between T1 and T2. Forty participants (44.4%) maintained at least one cognitive deficit at five months; 19 (21.1%) maintained two or more deficits at T3.

Both intervention groups received similar amounts of training sessions. Eighty-four participants (87.5%) had at least one impaired neuropsychological parameter and 54 (56.2%) had two or more at baseline.

No significant differences in cognitive ability between treatment groups were reported.

• The study lacked a clear description of the PC intervention.
• The use of an inpatient setting and the timing of interventions may have affected the outcome.
• The study did not address practice effects with repeated testing over time.

To determine the effectives of an erythropoietin-stimulating agent (ESA) and granulocyte–colony-stimulating factor (G-CSF) in reducing blood transfusion needs and neutropenia incidence in community-dwelling older adults with ovarian cancer

Woman aged older than 65 years diagnosed with stage III–IV epithelial ovarian cancer (from January 2000–December 2009) were identified as having received chemotherapy by procedure codes in Medicare within nine months of diagnosis. Cox models were used for analysis and included time-dependent covariates. ESAs and G-CSFs were identified by Healthcare Common Procedure Coding System codes for epoetin-alfa/darbepoetin-alfa and filgrastim/pegfilgrastim. Blood transfusion need was measured from the time of diagnosis to first Medicare claim indicating the receipt of blood transfusion. Neutropenia incidence was measured from the time of the first chemotherapy administration to the first claim of neutropenia. Patients who did not receive a blood transfusion or did not develop neutropenia were censored at the date of death or last date in Medicare claims (i.e., December 31, 2010), whichever occurred first. Overall survival was measured from the time of first chemotherapy administration until death or the end of the follow-up period (December 31, 2011). Patients not experiencing the event (death) by this date were censored.

• N = 5,572   
• AGE = Older than 65 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Stage III–IV epithelial ovarian cancer 
• OTHER KEY SAMPLE CHARACTERISTICS: Sociodemographics

• SITE: Multi-site   
• SETTING TYPE: Not specified

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

Retrospective cohort study using SEER Medicare linked database

• Cox Model
• Kaplan-Meier curves
• Propensity scores
• Logistic regression model
• Propensity score distribution plots

ESAa were effective in reducing blood transfusion need. G-CSFs were effective in lowering neutropenia incidence and were associated with improved survival in older adults with ovarian cancer. The interaction between ESA time and CSF time was significant (p = 0.0001).

The findings demonstrated that using epoetin-alfa or darbepoetin-alfa effectively lowers the blood transfusion needs by 48%–78% in patients receiving chemotherapy, which is comparable to prior randomized trials of patients with gynecologic and ovarian cancer. The use of a G-CSF was associated with a longer survival compared to those who received at least three doses of a G-CSF. The findings showed that patients who received fewer than three prophylactic G-CSF administrations did not experience better outcomes.

• Risk of bias (no random assignment)
• Findings not generalizable
• No ability to look at laboratory data that triggered the use of ESAs and G-CSFs
• No ability to look at intensity of chemotherapy
• Potential risk of ESAs or G-CSFs in relation to thrombocytopenia and bleeding events

This was a good study; however, it had a very focused patient population and may not be reproducible in the younger population. In addition, no information was provided regarding adverse events related to the use of ESAs or G-CSFs. Prior studies have shown a possible higher risk for mortality with the use of ESAs and G-CSFs. It is important to continue to look at established guidelines (Oncology Nursing Society, American Society for Clinical Oncology, National Comprehensive Cancer Network, Food and Drug Administration) for the use of ESAs and G-CSFs in the cancer population.

To assess effectiveness of calendula for prevention of acute radiation-induced dermatitis of grade 2 or higher during radiation therapy compared with trolamine

Patients were randomly allocated to application of trolamine or calendula on irradiated fields after each session. Patients started topical application of ointment at onset of radiation therapy, twice a day or more, depending on occurrence of dermatitis and pain, until completion. Patients were instructed not to use the agent two hours or less before an irradiation session or before treatment evaluation. No other prophylactic creams, lotions, or gels were allowed. Physicians were free to treat established dermatitis grade 2 or higher or allergy as considered appropriate. Clinicians were blinded to the treatment used

• The study sample was comprised of 254 female patients who were randomized to trolamine (n = 128) or calendula (n = 126) treatment.
• Age ranged from 26.5–74.5 years; mean age was 56.5 years in calendula arm and 55.1 years in trolamine arm.
• All patients were post-lumpectomy or post-mastectomy for nonmetastatic breast cancer.
• Patients received treatment with or without adjuvant postoperative chemotherapy or hormonal treatment.
• Standard irradiation fractionation (2 Gy per session, five sessions per week) was used.

The study took place at Centre Leon Berard in Lyon, France.

The study used a randomized, blinded controlled trial design.

• Acute dermal toxicity was evaluated according to the Radiation Therapy Oncology Group scale.
• Pain was assessed weekly on a 10 cm visual analog scale.
• The occurrence, duration, and reasons for interruption of radiation therapy or of allocated cream application were registered, as were allergic reactions and quantity of agents used.
• At the end of the study, patients completed a questionnaire to assess satisfaction with ease of application, pain, and dermatitis relief.
• Qualitative measures were compared using Chi Square or Fisher’s exact test, as appropriate.
• For quantitative measures, the Student’s t test or Wilcoxon-Mann-Whitney tests were used.

The occurrence of acute dermatitis of grade 2 or higher was significantly lower (41% versus 63%; p < .001) with use of calendula versus trolamine. Benefits were most marked at sites at risk of maceration (submammary fold, armpit, and tangential area) and sites with thin skin. Patients receiving calendula had less frequent interruption of radiation therapy. Mean length of treatment interruption was 10 days (range 2–22 days). Fifteen treatment interruptions were observed in trolamine group, 12 due to skin toxicity. No allergic reactions were observed in the calendula group, whereas four patients in the trolamine group developed allergic-type reactions of pruritus and urticaria. Patients receiving calendula had significantly reduced radiation-induced pain. Mean maximal pain evaluated in calendula group was 1.54 and 2.10 in the trolamine group (p = 0.03). Self-assessed satisfaction was greater with calendula. Prevention of erythema was 69% in the calendula arm versus 39% in the trolamine arm. Prevention of pain was 65% with calendula versus 46% with trolamine. Calendula was considered more difficult to apply as noted by 30% of the calendula group versus 5% of trolamine group. The risk of skin toxicity of grade 2 or higher was significantly increased for women whose body mass index was 25 or higher (p < 0.001), who had received chemotherapy before radiation therapy after a lumpectomy (p = 0.01), and who were using trolamine (p < 0.001).

Calendula was shown to be effective in reducing skin toxicity of radiation compared to trolamine.

Because of differences in texture, color, and smell, it was not possible to perform a double-blind randomized study.

To assess the effectiveness of Calendula for the prevention of acute radiation (RT)-induced dermatitis of grade 2 or higher during RT compared with trolamine (Biafine).

• Patients were randomly allocated to application of trolamine (n = 128) or Calendula (n = 126) on irradiated fields after each session.
• Patients started topical application of ointment on irradiated skin at onset of RT, twice a day or more, depending on the occurrence of dermatitis and pain, until completion of RT.
• Patients were instructed not to use agents two hours or less before an irradiation session or before treatment evaluation.
• No other prophylactic creams, lotions, or gels were allowed.
• Physicians were free to treat established dermatitis, grade 2 or higher, or allergy as considered appropriate.
• Clinicians were blinded to the treatment used.

• The sample was comprised of 254 women (Calendula, 128; trolamine, 126).
• Mean age was 56.5 years in the Calendula arm and 55.1 years in the trolamine arm (range 26.5–74.5). 
• Patients were post lumpectomy or mastectomy for nonmetastatic breast cancer.
• Patients were undergoing treatment with or without adjuvant postoperative chemotherapy or hormonal treatment.
• Standard irradiation fractionation (2 Gy per session, five sessions per week) was used.
• Patients who underwent lumpectomy received 52 Gy from two tangential fields to the whole breast with 10 Gy boost to the tumor bed.
• Patients who underwent mastectomy received 46 Gy to the chest wall.
• If relevant, internal mammary and supraclavicular nodes were irradiated.

• Single site
• Centre Leon Berard, Lyon, France

The study was a randomized, blinded, controlled trial.

• Once weekly acute dermal toxicity was evaluated according to the Radiaton Therapy Oncology Group (RTOG) scale.
• Pain was assessed weekly on a 10-cm visual analog scale (VAS). The occurrence, duration, and reasons for interruption of RT or of allocated cream application were registered, as were allergic reactions and quantity of agents used, until completion of RT.
• At study end, patients completed a questionnaire to assess satisfaction with respect to ease of application, pain, and dermatitis relief.
• Qualitative measures were compared to the chi-square test or Fisher exact test, as appropriate.
• For quantitative measures, Student’s t-test or Wilcoxon-Mann-Whitney test was used.

• The occurrence of acute dermatitis of grade 2 or higher was significantly lower (41% versus 63%; p < 0.001) with the use of Calendula versus trolamine.
• Twenty patients given trolamine presented with grade 3 toxicity (p = 0.034).
• Benefits were most marked at sites at risk of maceration (submammary fold, armpit, and tangential area) and sites with thin skin.
• Patients receiving Calendula had less frequent interruption of RT. Mean length of treatment interruption was 10 days (range 2–22 days). Fifteen treatment interruptions were observed in the trolamine group; 12 were due to skin toxicity.
• No allergic reactions were observed in the Calendula group, whereas four patients in the trolamine group developed the allergic-type reactions of pruritus and urticaria.
• Patients receiving Calendula had significantly reduced RT-induced pain.
• Mean maximal pain evaluated in the Calendula group was 1.54 and 2.10 in the trolamine group (p = 0.03).
• Self-assessed satisfaction was greater with Calendula.
• Prevention of erythema:  69% Calendula versus 39% trolamine.
• Prevention of pain:  65% with Calendula versus 46% trolamine.
• Calendula was considered more difficult to apply as noted by 30% of the calendula group versus 5% of the trolamine group.
• The risk of skin toxicity of grade 2 or higher was significantly increased for women whose body mass index was ≥25 kg/m² (p < 0.001) and for women who had received chemotherapy before RT after a lumpectomy (p = 0.01), and for those using trolamine (p < 0.001).

• A delivered dose of 61 Gy or less was not identical in the treatment groups, favoring the Calendula group over the trolamine group.
• Because of differences in texture, color, and smell, it was not possible to perform a double-blind, randomized study. Simple blinding of the clinician removed bias with respect to the main objective of the study.

The objective of the study was to assess the effectiveness of tunneled pleural catheters in the treatment of malignant pleural effusions.

Initial enrollment of the first one-third of patients (n = 9) involved 2:1 randomization to the newly available and not U.S. Food and Drug Administration (FDA)-licensed PleurX^® catheter or chest tube-administered chemical pleurodesis with doxycycline. The remaining 19 patients after October 1997 all were treated with the PleurX^® catheter.

• The study reported on a sample of 28 patients with malignant pleural effusion for a total of 31 hemithoraces (three patients had bilateral hemothoraces) who entered on the study over 53 months.
• The mean age was 60 years, with a range of 31–85 years.
• Of the sample, 46% were males and 54% were females.
• All patients had a moderate-sized, free-flowing pleural effusion without contralateral effusion or previous sclerotherapy or local radiation therapy.
• Patients must have shown previous improvement with thoracenteses, adequate performance scale (Karnofsky at least 50), absence of chylous effusion, HIV positivity, mediastinal shift, infection in pleural space, prior lobectomy or pneumonectomy on affected side, and presence of hemostatic disorder.
• Inclusion criteria were loosened to include anyone with symptomatic effusion after the randomization stopped and the Denver PleurX catheter was commercially available.
• Two patients who had attempted chemical pleurodesis previously and two with loculated effusions were allowed to participate after the Denver PleurX catheter was licensed by the FDA.

• The single-site study was conducted in both the inpatient and outpatient setting.
• All patients were treated by the Interventional Radiology Department.
   

• Patients were underging the transitional phase of care after initial treatment.
• The study has clinical applicability for end-of-life and palliative care.
   

The study had a prospective convenience sample, with randomization of the initial one-third of patients. The study for the remaining two-thirds of the patients had a nonrandomized prospective design.

• Measurement of the type, extent, and response of pleural effusion was validated by computed tomography or frontal, lateral, and decubitus chest radiographs.    
• Assessment of dyspnea is described, but the instrument or measurement criteria are not described.
• Complication rate was calculated based upon a researcher-designed list of complications.
• Need for hospitalization related to placing the catheter was measured.
• Catheter-related discomfort was measured by patient report of pain.
   

• All catheters were placed successfully without procedural complication; however, two patients (10.7%) had three late complications. They included external catheter migration (1), tumor tracking along catheter route (1), and infection (1).
• Follow-up time with catheters ranged from 3–618 days, with a median of 51 days.
• Dyspnea improvement was seen in 26 of 28 patients (93%), and when including patients with more than one procedure, improvement was 93%. This symptom improvement was enduring and present in 20 of 22 patients (91%) alive at 30 days post-procedure.
• Persistent control of pleural effusions with a defined drainage regimen based upon the prior drainage was effective in 90% of catheters placed.
• Spontaneous pleurodesis was achieved in 42% of hemithoraces, with a median time of 19 days (range 7–96 days). Only one patient developed recurrent pleural effusion, and this patient had only one locule of his effusion treated with catheter insertion.
• Five of 28 patients required additional pleural interventions (successful treatment in 23 of 28 patients [82%]).
• Five patients required additional procedures to achieve control of the pleural effusion, but the number of complex, chylous, or loculated effusions was limited.

This small, single-site, prospective study of the effectiveness of tunneled pleural catheters showed effective pleural drainage, spontaneous pleurodesis equivalent to chest catheter pleurodesis, reduced days of hospitalization (as the procedure can be safely performed outpatient), reduced distressing symptoms, and rare complications.

• The study had a small sample size of less than 30 patients.
• Short survival after catheter insertion did not permit complete evaluation of efficacy.

Its use in patients with refractory effusions could be advantageous, as it represents patients who have received other therapies prior to catheter insertion. The average life expectancy of patients with malignant pleural effusions is only 6–12 months, with as many as half of patients dying within 30 days. Patients with malignant pleural effusions represent a group who experience significant symptoms that affect quality of life. Interventions that are low-intensity, can be performed quickly and with limited recovery time, and can be managed in the ambulatory or home setting are optimal. Nurses can act as advocates for innovative management of malignant pleural effusions that enhance patient independence. Nurses are key patient and family educators who provide guidance, support, and hands-on instruction in management of tunneled pleural catheters. Their follow-up with patients and caregivers assist in the detection of complications, as well as evaluation of efficacy. Follow-up nursing assessment for symptom relief and spontaneous pleurodesis or the need for additional interventions may be especially important for these patients receiving end-of-life care with limited contact with physicians.

The purpose of the study was to measure the efficacy of black cohosh (one capsule, Cimicifuga racemosa 20 mg twice daily) for the treatment of hot flashes in women with and without a history of breast cancer.

Participants received four weeks of therapy with black cohosh or an identical appearing placebo. The black cohosh or placebo was given as one tablet twice per day. After completing the first four weeks, participants were crossed over to the alternative treatment arm.

• The study randomized 132 participants. 107 participants (81%) completed the first five weeks of hot flash diaries; 99 participants (75%) completed the entire nine weeks of therapy. The mean age was 56 years.
• Inclusion criteria:
  • History of breast cancer, a perceived increased risk of breast cancer, or did not want to take estrogen due to the increased risk of breast cancer.
  • Participants experienced bothersome hot flashes (14 or more per week) for at least one month.
  • Concomitant therapy with tamoxifen, raloxifene, or an aromatase inhibitor was allowed as long as patient had been on the therapy for one month.
  • Use of vitamin E and/or soy was allowed if the patient had been on a stable dose for one month or more and planned to continue the same dose during the entire study period.
• Exclusion criteria:
  • Receiving concomitant chemotherapy, androgens, or estrogens.
  • Any prior use of black cohosh; use of antidepressants within the prior two weeks (or planned use during the next nine weeks); or current or planned use of other agents for treating hot flashes (e.g., clonidine, belladonna alkaloids, dehydroepiandrosterone) 
  • Other oral herbal therapies, therapeutic herbal teas, or tinctures during the study period were not allowed because of potential interactions with black cohosh.

This was a double-blind, randomized, cross-over clinical trial with two four-week periods.

Participants completed a prospective, daily hot flash diary during the baseline week and then during the two four-week crossover treatment periods. Hot flash scores were measured by assigning points to each hot flash based on severity (1 for mild to 4 for very severe) and then adding the points for a given time period.

The primary end point was the average intrapatient hot flash score (which is a construct of average daily hot flash severity and frequency) difference between the baseline week and the last study week of the first treatment period. Hot flash activity was analyzed in a number of ways. The difference between treatment week 4 (study week 5) and baseline  hot flash score (study week 1) was compared between placebo and black cohosh arms by standard two-sided Wilcoxon procedures. Confidence intervals were constructed for median reductions in hot flash frequency and score. Patients receiving black cohosh reported a mean decrease in hot flash score of 20% (comparing the fourth treatment week to the baseline week) compared with a 27% decrease for patients on placebo (p = .53). Mean hot flash frequency was reduced 17% on black cohosh and 26% on placebo (p = .36). Patient treatment preferences were measured after completion of both treatment periods. Thirty-four percent of patients preferred the black cohosh treatment, 38% preferred the placebo, and 28% did not prefer either treatment. Toxicity was minimal across both groups.

This trial failed to provide any evidence that black cohosh reduced hot flashes more than the placebo.

Limitations of the study included using a subset of participants did not have a diagnosis of breast cancer but met the eligibility criteria of a perceived increased risk of breast cancer, or did not want to take estrogen because of the increased risk of breast cancer. The numbers of participants with and without a breast cancer diagnosis were not specified.

PHASE OF CARE: Late effects and survivorship

• No botanicals reviewed were recommended for practice. 
• The benefits of alpha benzopyrones are balanced with harms.
• The effectiveness of gamma benzopyrones is not established
• The effectiveness of saponin is not established.
• The effectiveness of horse chestnut seed extract in combination therapies is not established
• The effectiveness of pine bark extract versus gama benzopyrone is not established.
• The effectiveness of selenium is not established.

One botanical intervention, alpha benzopyrones, had benefits that were balanced with harms, but the effectiveness of all other botanical interventions was not established. At this time, botanical supplements cannot be recommended as part of a therapeutic protocol to manage lymphedema in patients with cancer.

At this time, there is limited high-quality evidence investigating the potential use of botanicals in the treatment of cancer-related lymphedema. The number of studies using botanical interventions is small, and most possess significant design flaws. This review did not clearly state the inclusion and exclusion criteria used to select literature, and patient demographics were not described.

At this time, botanical supplements should not be considered as part of routine care in the treatment of cancer-related lymphedema. Nurses must be knowledgeable about the various botanical supplements patients may be using, and they must always assess patients for the use of any botanical supplements. Nurses should council patients who are taking or who ask about botanical supplements on the current state of the research.

To assess the benefit of antiseptic mouthwash in patients with leukopenia because of a decrease in micro-organisms

• Patients were randomized to chlorhexidine or fluoride rinse (control group).
• Patients rinsed three times per day for 30 seconds from the start of chemotherapy to the end of leukopenia.
• Pre-rinsing during and after leukopenia, aerobic and anaerobic bacteria in oral cavity were counted.
• Patients were assessed for oral mucositis.
• Patients did not brush teeth when leukopenic.

• The sample consisted of 47 patients.
• Patients had solid tumor and hematologic diagnoses.

• Bacterial swabs were taken pre-, during and post-treatment.
• Clinician assessment and mucositis scores were taken.
• C-reactive protein was measured.

• In the chlorhexidine group, a significant decrease in aerobic (p = 0.042) and anaerobic (p = 0.008) bacterial flora were identified.
• In the control group, the numbers of bacteria were unchanged (p > 0.05).
• More patients in the chlorhexidine group had severe mucositis and inflammation, but this was not significant.

Chlorhexidine did not provide a clinical benefit against mucositis.

• The study had a small sample.
• The oral assessment was unclear.