To describe the effects of enteral naloxone for the treatment opioid-induced constipation.

Patients in the treatment group received opioids and enteral naloxone for suspected opioid-induced constipation. Patients in the control group received opioids and were randomly chosen from patients receiving opioids during the study period.

• The study reported on a sample of 46 pediatric patients (23 in the treatment group and 23 in the member-matched control group).
• Mean patient age was 6.4 years (range 5 months to 18 years) in the treatment group and 6.1 years (range 4 months to 17 years) in the control group.
• The sample comprised 14 boys (61%) in the treatment group and 14 boys (61%) in the control group.
• The morphine equivalent was 86 mg per day (SD = 83, range 9–197) in the treatment group and 20 mg per day (SD = 17, range 1.3–59) in the control group.
• Mean length of stay in the pediatric intensive care unit was 15 days (SD = 8, range 7–43) in the treatment group and 10 days (SD = 7, range 3–31) in the control group.
• Mean length of stay in the pediatric intensive care unit five days before enteral naloxone initiation ranged from 0 to 13 days.

Pediatric intensive care unit of a children’s hospital in Alabama

This was a retrospective study conducted from January 2003 to February 2004.

• Daily stool output and opiate usage
• Nutrition
• Adjuvant laxative use
• Side effects

• In the treatment group, mean stool output before enteral naloxone was 0.14 (SD = 0.38) stools per day. After initiation, mean stool output was 1.6 (SD = 1.14) stools per day (p < 0.001).
• In the control group, mean stool output was 0.53 (SD = 1.21) stools per day.
• Eighteen patients in the treatment group (78%) received other bowel agents in addition to enteral naloxone (13 Miralax^®, 7 bisacodyl, 4 glycerin suppositories, and 1 milk-and-molasses enema).
• Eight patients in the control group (35%) received other bowel agents (4 Miralax, 4 bisacodyl, 1 glycerin suppository, and 1 milk-and-molasses enema).
• A significant inverse relationship existed between opioid dose and increase in stool output after naloxone initiation (r² = 0.17; p < 0.05).
• Two patients experienced withdrawal symptoms. One was caused by medication error.

Enteral naloxone may be effective for increasing stool output in opioid-induced constipation but carries risk of withdrawal symptoms. Additional study is needed.

• The study was retrospective.
• The study was not able to control several variables that could be confounders (e.g., dose, duration, and type of opioids; use of additional bowel stimulants; amount of nutrition).
• Other patients may have had unrecognized mild withdrawal symptoms.
• Stool size or weight would have been a more objective outcome measure, but was not available.
• A significant difference existed in morphine equivalent per day between the treatment and control groups (p = 0.01).

• DATABASES USED: Medline (Ovid), MEDLINE In-Process, other nonindexed citations (Ovid), Embase (Ovid), PsycINFO (Ovid), Cochrane Central Register of Controlled Trials (Ovid), and CINAHL (EBSCO) 
• KEYWORDS: Extensive search terms per database were provided
• INCLUSION CRITERIA: One randomized, controlled trial of interventions for the management of persistent post-treatment fatigue of adult thyroid cancer survivors  
• EXCLUSION CRITERIA: Studies primarily focusing on patients with thyroid cancer around the time of thyroid cancer treatment (e.g., first six months around first surgery or radioactive iodine treatment) or those focusing on the preparation procedures for radioactive iodine treatment or scanning were not eligible for inclusion. Pharmacologic (including hormonal) and nonpharmacologic interventions were included.

• FINAL NUMBER STUDIES INCLUDED = 4 (one of these was a second report on the same population as in another study)
• TOTAL PATIENTS INCLUDED IN REVIEW = 75 
• SAMPLE RANGE ACROSS STUDIES: 15–36 patients
• KEY SAMPLE CHARACTERISTICS: The target population was thyroid cancer survivors aged greater than 18 years whose disease was of any histologic subtype and who completed primary treatment (surgery with or without other treatment). To be eligible for inclusion, more than half the study population was required to consist of thyroid cancer survivors, or a thyroid cancer subgroup data analysis needed to have been reported. There was no specific requirement relating to disease stage or disease status. All patients were receiving thyrotropin suppressive therapy.

PHASE OF CARE: Late effects and survivorship

Two studies examined use of T3 and T4. In one study comparing the combination of T3 and T4 to T4 alone, the fatigue subscale of the Profile of Mood states showed significant improvement at five weeks. One study using T4 compared to maintenance TSH suppression showed improvement in one subscale of the multidimensional fatigue scale at six months but no change in other fatigue subscales. Two references that reported on one study examined the impact of an exercise program.

There is insufficient evidence to demonstrate the impact of the administration of T3 or T4 on fatigue in patients who had thyroid cancer.

There was a small number of studies included, the number participants recruited in the identified studies was small, and some of these studies were of low quality.

There is insufficient evidence to evaluate any benefits of the administration of T3 or T4 for the management of fatigue among patients receiving TSH suppressive therapy

To assess chlorhexidine-impregnated sponge dressings for prevention of catheter-related infections

Patients were randomly assigned to one of four treatment groups. Groups were (a) standard dressing every three days, (b) chlorhexidine sponge dressing every three days, (c) standard dressing every seven days, and (d) chlorhexidine dressing every seven days. Insertion sites were the radial artery or subclavian vein whenever possible. Insertions were done with maximal barriers and antisepsis techniques. Semitransparent dressings were used for all. Povidone-idodine was used for skin antisepsis with each dressing change. Patients were followed for 48 hours after discharge from the ICU. A noninferiority analysis was planned with the identification of a 3% difference in catheter-related infection (CRI) rate as the comparison value. Only cultured catheters were considered to compare three- versus seven-day dressing intervals.

• N = 1,636 in intent to treat analysis, 28,931 catheter days   
• MEDIAN AGE = 62 years
• AGE RANGE = 50–74 years
• MALES: 64.3%, FEMALES: 35.7%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: 64 patients (3.9%) had metastatic cancer and 52 (3.2%) had hematologic cancer
• OTHER KEY SAMPLE CHARACTERISTICS: 45% were arterial catheters and, of these, 41% were femoral; 54.3% were venous catheters and, of these, 40% were subclavian; the rest were jugular or femoral catheters.

• SITE: Multi-site   
• SETTING TYPE: Inpatient    
• LOCATION: France

• Four-group, single-blind randomized, controlled trial

• CRI defined as either catheter-related sepsis without bloodstream infection or catheter-related bloodstream infection. 
• Catheter colonization was the major outcome for comparison of three- versus seven-day dressing intervals
• Catheter colonization: At least 1,000 colony forming units/ml
• CRI defined as combination of (a) body temperature ≥ 38.5 C or hypothermia, (b) catheter tip culture with at least 10³ CFUs/ml, (c) pus at insertion site or resolution of clinical sepsis with catheter removal, and (d) absence of any other foci for infection.

Use of chlorhexidine dressings overall were associated with a 0.6 CRI rate compared to 1.4 in the control groups per 1,000 catheter days (hazard ratio [HR] = 0.39, p = 0.03). Of those assigned to seven-day dressings, 50.6% had more frequent unplanned dressing changes. There was no significant difference in colonization rate between those having three- and seven-day dressing intervals. There was a slight but insignificant increase in skin colonization in the seven-day group at the time of catheter removal. Overall, the rate of central line–associated bloodstream infection (CLABSI) was lower (p = 0.005) with sponge dressings. 

Use of chlorhexidine sponge dressing reduced the incidence of catheter-related bloodstream infections. Analysis by dressing change interval did not show any significant difference in outcomes.

• There was no analysis of each separate group to determine which combination of dressing frequency and dressing type was most effective.  
• Low volume of patients with cancer
• No subgroup analysis by catheter insertion site. A rather large proportion were femoral and jugular sites.

Findings showed lower CLABSI rate and risk with use of chlorhexidine-impregnated sponge dressings. Findings also suggest no difference in infection outcomes related to catheters according to the frequency of dressing changes, although more than half of patients assigned to dressing changes every seven days needed changes more frequently for soiling or separation. Chlorhexidine-impregnated dressings can reduce CLABSI rate, and less frequent catheter dressing changes can be done with no apparent increase in infections.

To evaluate the effectiveness of the combination of palonosetron, aprepitant, and dexamethasone for prevention of chemotherapy-induced nausea and vomiting (CINV)

In cycle 1 of chemotherapy, safety and efficacy was assessed. In subsequent cycles, assessment of nausea was emphasized. Actual dosage and schedule of medications was not described. Patients completed Functional Living Index-Emesis (FLIE) scores at various time points in the study; however, these specific time points were not stated.

• The study consisted of 50 participants.
• Median age was 60.6 years, with a range of 31–68.9 years
• All patients were female.
• Diagnoses were ovarian, peritoneal, uterine, or fallopian tube cancer.
• The majority of patients (96%) had undergone previous surgery, but only one patient had received prior chemotherapy.
• All patients were scheduled to receive paclitaxel and carboplatin for several cycles.

All patients were in active treatment.

This was a prospective, open-label trial.

• Complete response (CR) was defined as no emesis and no need for rescue medications.
• The FLIE questionnaire was used.

• Four patients dropped out after experiencing uncontrolled nausea and vomiting.
• FLIE scores were reported for nausea and vomiting per cycles and days.
• The percent of patients experiencing CR was not reported.
• Treatment-related adverse events were few and of low grades.

The combination of drugs used appeared to be well tolerated. Firm conclusions regarding efficacy cannot be drawn.

• The study had a small sample.
• The study report did not provide much actual information or report overall results.
• Only cumulative drug dosages were reported; no information was provided about dosages and schedules.
• No control or comparison group was included.

This study provides some evidence that combinations of palonosetron, aprepitant, and dexamethasone can be well tolerated.

The purpose of the study was to establish the maximum-tolerated dose of paclitaxel and investigate whether prophylactic G-CSF and antibiotics would allow further dose escalation of paclitaxel in treatment-naïve patients.

Doses were given in increasing increments to groups of three patients to determine dose-limiting toxicity (DLT). Part A: Paclitaxel escalation without prophylactic G-CSF (unless DLT from neuropathy). Part B: Level 7 etoposide administered with G-CSF. Part C: Same as part B plus prophylactic antibiotics (ciprofloxacin and roxithromycin). With a hematologic toxicity recovery to CTC less than 3, a subsequent cycle was allowable with a max delay of two weeks. Dose reduction was given if grade 2 CTC hematologic toxicity persisted after a two-week delay and/or there was a greater than grade 2 nephro- or neurotoxicity.

• 47 participants were included in the study.
• Age range was 32–74 years.
• 31.9% were women; 68.1% were men
• Non-small cell lung cancer: squamous cell carcinoma (n = 20), adenocarcinoma (n = 18), other (n = 9)
• World Health Organization performance status 0 (n = 13), 1 (n = 29), 2 (n = 3), unknown (n = 2)
• Stage IIIA (n = 13), IIIB (n = 9), and IV (n = 25).

Single-site outpatient setting in the Netherlands.

Active treatment

Prospective dose-finding study.

• Dose-limiting toxicity: defined as granulocytes less than 0.5×10⁹/L lasting for seven days or more, granulocytes less than 0.5×10⁹/L, fever of 38.5ºC or higher, platelet count less than 25×10⁹/L, and any toxicity higher than grade 2 (with the exception of nausea/vomiting responsive to treatment) occurring during the first cycle
• Blood cell counts: WBC, ANC, platelets, hemoglobin
• Adverse events: fever, polyneuropathy, anorexia, nausea, vomiting, diarrhea, cardiac, asthenia, hemorrhage, electrolyte disorder, hematologic toxicity
• Infections
   

In total, 189 cycles of chemotherapy were administered. Forty-three of the 47 patients enrolled survived treatments. Thirty-four completed the full protocol (febrile neutropenia or dose delays from toxicity were the main reasons for incomplete cycles).

The use of G-CSF and antibiotics allows for higher chemotherapy doses in patients with stage IIIA, IIIB, and IV non-small cell lung cancer, which could increases survival.

• Small sample (less than 100 participants)
• The findings circumvent details about survival time in the patients who received G-CSF and prophylactic antibiotics allowing for higher chemotherapy doses; therefore, it is unknown if the patients who survived the longest were the recipients of the higher chemotherapy doses with G-CSF and antibiotics, which was the goal of the study.
   

The administration of G-CSF and prophylactic antibiotics may reduce neutropenia and infections increasing the DLT, allowing for higher doses of chemotherapy for better chance of prolonged survival. However, research in this area needs further exploration.

To evaluate the efficacy of probiotics in the prevention of radiation-induced diarrhea

Patients who had undergone adjuvant, postoperative radiation to the abdominal or pelvic area, alone or in combination with chemotherapy, and were admitted to the hospital were randomized to one of two groups: “5” Strain Dophilus (L group) or Hylak Tropfen Forte drops (H group).

• The study reported on 42 patients.
• The median age of patients in the L group was 62 years with a range of 34–82 years, and the median age of patients in the H group was 67 years with a range of 43–83 years.     
• The sample was 66% male and 33% female.
• The majority of patients in the L group had colorectal cancer and the majority of patients in the H group had prostate or rectosigmoid junction cancer.
• The number of patients in the L group with a body mass index (BMI) of normal weight was equal to the number of patients with an overweight BMI. In the H group, more patients had an overweight BMI than a normal BMI.
• In the L group, 55% of patients also received chemotherapy. In the H group, 50% of patients also received chemotherapy.
   

This study was conducted at a single-site, inpatient setting in Ruzomberok, Slovakia.

All patients were undergoing the active treatment phase of care.

This was a randomized, parallel-group, nonplacebo controlled trial.

Patient diaries were used to record the number and consistency of stools, presence of bleeding or abdominal pain, and use of antidiarrheals or antibiotics.

• Patients in the L group had a higher number of daily bowel movements (BMs) (n = 4.16, range = 1.2–9.7) than in the H group (n = 2.52, range = 0.7–5.3).
• In the second week, the weekly number of BMs was significantly higher in the L group (p < 0.01) compared to the H group.
• The number of BMs in the H group increased at week 3.
• A significant increase was reported in the number of BMs in patients receiving only radiation versus radiation plus chemotherapy.
• Fewer patients in the L group (27%) required an antidiarrheal (specifically diphenoxylate) compared to the H group (55%).
• Fewer patients in the L group (9%) required antibiotics versus in the H group (25%).
• Abdominal pain was similar between groups with 25% of patients reporting the side effect in the L group compared to 22% in the H group.
• One subject in the H group reported blood in the stool at day 9.

Probiotics  may be effective in the prevention of radiation-induced diarrhea.

• The sample size was small, with fewer than 100 patients.
• A control group was not included.
• Patients' diets and the radiation technique could have varied between groups.

The use of probiotics may have some benefit in the prevention of radiation-induced diarrhea; however, more studies (including control arms) are needed.

Identify whether aqua lymphatic therapy (ALT) is a safe method of treatment for lymphedema

ALT, which uses the physical properties of water to enable women to perform self-massage and exercises, was performed weekly in the intervention group during 45-minute sessions in a warm (32–33º C) hydrotherapy pool 1.2 m deep. The control group was instructed to continue to perform the self-management measures as usual up to the beginning of the study.

• The study sample was comprised of 48 female patients.
• Mean age was 56 years, with a range of 31–81 years.
• All patients had unilateral lymphedema secondary to breast cancer surgery with axillary node dissection.
• Patients had undergone or completed Intensive complex physical therapy and were at least two weeks in the self-management state.

The study took place in an outpatient setting hydrotherapy pool in Ramet Ga, Israel.

The study used a single-blinded randomized controlled trial design.

• Volume of limbs was measured using water displacement.
• Adherence to treatment was assessed using an adherence diary.
• Quality of life, including physical, psychological, and social withdrawal factors, was assessed using the Upper Limb Lymphedema Questionnaire (ULL 27).
• Safety was determined based on an absence of related infections.

No infections or worsening of limb volume was noted in the post-treatment evaluation. Mean adherence to self-management was 28%. Adherence in the ALT group was 79%, possibly because of the low frequency of therapy and group exercise. The warm temperature environment of the water has an immediate positive influence on limb volume, but no long-term effect was observed. The ALT group showed improved emotional and social dimensions, while the control group demonstrated a worsening quality of life, despite unchanged physical dimensions.

ALT was found to be a safe method for maintenance therapy in patients with mild-to-moderate arm lymphedema. Warm water temperature environment appeared to have an immediate short-term positive influence on limb volume.

• The study sample was small, with less than 100 patients.
• Randomization did not produce two similar groups in all baseline measures, such as breast and chest wall radiation, chemotherapy, and type of surgery; however, these measures were not found to be a factor in the study.

Access to warm water public pools and cleanliness of pools is essential to avoid ear, sinus, and respiratory infections. Staph bacteria, the usual cause of skin infections, is not described in the literature as being present in pool water. Patients should be cautioned to not participate in ALT if they have skin infections, cuts, or wounds. The quality of life improved in the ALT group, while it declined in the control group, despite no physical changes in limb volume between the two groups. This might indicate that offering something, or a different, exercise could positively impact quality of life and potentially adherence.

• FINAL NUMBER STUDIES INCLUDED = 26
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,830
• SAMPLE RANGE ACROSS STUDIES: 10 of 26 had a sample size less than 30
• KEY SAMPLE CHARACTERISTICS: 13 studies of breast, 3 of prostate, 2 of colorectal, 2 of nasopharyngeal, 2 of hematological, 1 of gynecologic, and 3 of various types of cancer. The mean age ranged from 40–70.6 years. Twelve studies reported cancer stage from mostly I to III. Eight studies included patients who had completed active treatment.

PHASE OF CARE: Active antitumor treatment

Exercise was supervised or home-based, 15–50 minutes in length, two to five times per week for 6–24 weeks. Overall aerobic exercise had a small but significant effect (p = 0.01). Studies with patients past active treatment had a moderate effect on fatigue compared to usual care (p < 0.01). Professionally led exercise led to significant improvements in fatigue (p = 0.02). Professionally led exercises lasted 20–30 (p < 0.01) or 50 minutes (p < 0.02), two to three (p < 0.01, p = 0.01) times per week for eight weeks (p < 0.01). No significant difference by exercise type existed.

Structured exercise can have a positive effect on CRF. The effect may be greater when activity is professionally led and after active treatment.

• The majority of patients had breast cancer, limiting generalizability.
• Other potential contributing factors to CRF were not reported in these studies.

Consistent physical activity should be discussed with patients with cancer to lessen the effects of CRF.

To compare single-dose palonosetron with single-dose granisetron in the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) with cisplatin for moderately emetogenic chemotherapy

Subjects were stratified according to having chemotherapy with cisplatin and were randomly assigned to either palonosetron during cycle 1 and granisetron during cycle 2 or the opposite sequence of antiemetics. Patients receive 0.25 mg IV palonosetron or 3 mg IV granisetron 30 minutes prior to chemotherapy infusion. Other drugs with antiemetic efficacy, including dexamethasone, were not permitted; however, use of rescue medication was allowed. Use of rescue medications was standardized. Patients used diaries to record the number of emetic episodes.

• The study consisted of 122 participants.
• Patients' mean age was 52.2 years (SD = 10.67 years), with a range 17.36—74.78.
• The sample was 46.6% female and 53.4% male.
• Cancer types were lung, breast, colorectal, and gastric.
• Approximately 40% of participants had received previous chemotherapy and experienced prior CINV.
• All patients were scheduled to receive two courses of moderately emetogenic chemotherapy (MEC) or cisplatin 60–80 mg/m².
• Patients were excluded if they were scheduled to receive highly emetogenic chemotherapy or radiotherapy to the upper abdomen or cranium.
• Patients were excluded if they had grade 2 or 3 CINV within 24 hours prior to the start of the study.
• All patients had a life expectancy of three months or more.

The study was conducted at multiple sites in China.

All patients were in active treatment.

This was a randomized, double-blind, crossover comparative trial.

• Patients recorded the number of emetic episodes, maximum severity of nausea, onset of initial symptoms, and use of rescue antiemetics in diaries.
• Nausea was graded on 4-point Likert-type scale according to degree of interference with normal daily life.
• Complete protection(CP) was defined as no emetic episodes and no use of rescue medication. Major protection was defined as 1–2 emetic episodes. Treatment failure was defined as three or more episodes of vomiting.

• No significant differences were found between treatment groups during the acute, delayed, and overall phases.
• Palonosetron and granisetron were comparable in terms of complete response rates (72.16 with palonosetron and 67.74 with granisetron).
• Time to onset of the first emetic episode was similar in both groups.
• Both drugs were well tolerated, and no serious adverse events were reported.
• Constipation and dizziness were the most frequently observed adverse events in both groups.

The efficacy of single-dose, 0.25-mg palonosetron was not inferior to 3 mg granisetron for the prevention of CINV in the acute, delayed, and overall periods.

• Adherence to diary recording was not discussed.
• Use of rescue medications was not discussed.
• This study compared only two drugs with single-dose administration, which are not recommended for standard antiemetic approaches.
• Nausea was defined in terms of interference with life activities rather than the experience of the symptom.

Palonosetron appears to have similar efficacy as granisetron for prevention of CINV in patients receiving MEC.

To determine the efficacy and safety of radiofrequency ablation with percutaneous osteoplasty in the treatment of painful extraspinal bone metastases resistant to the conventional treatment of pain

Radiofrequency ablation involved the insertion of a needle at the bone lesion using a local anesthetic. An electrode was inserted into the needle and delivered heat from 70–90°C for a mean duration of 8.6 minutes. Immediately after this procedure, bone cement was injected into the lesion through the needle. The procedure was guided by fluoroscopy, and the amount of bone cement was determined by measuring the tumor size (the mean volume of bone cement was 6.6 ml; SD = 4.6 ml). The patient underwent a computed tomography scan after the injection of bone cement. Study measurements took place at baseline, 24 hours after treatment, and at the three- and six-month follow-up.

• N = 38  
• MEAN AGE = 52.6 years (SD = 12.2 years)
• MALES: 53%, FEMALES: 47%
• KEY DISEASE CHARACTERISTICS: Most frequent diagnosis was lung cancer followed by breast, thyroid, and liver cancers with a life expectancy of less than three months; number of treated lesions ranged from one to three

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Shanghai, China

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care 

Retrospective, single-arm, repeated-measures study; patients served as their own controls

Pain was measured by a 0–10 Visual Analog Scale (VAS), and quality of life was assessed using the Karnofsky Performance Status (KPS) scale. Data were collected by one physician at baseline and 24 hours after the intervention. Follow-up measurements (three and six months) were made at the outpatient office visit or by a telephone interview. Pain medication used by the patient was also documented. Functional recovery was evaluated by the patient’s ability to walk, and technical success was determined by the absence of major complications as defined by the Society of Interventional Radiology.

There was significant pain reduction (p < 0.001) compared to baseline as measured by the VAS at baseline, 24 hours, three months, and six months. Also at these time points, quality of life significantly improved (p < 0.05) as measured by the Karnofsky performance scale. Six months later, 32 patients no longer used narcotic analgesia (eight of these patients now used NSAIDs). Ten of the 25 patients who had limited walking ability before treatment were able to walk immediately after treatment. Six months later, 16 of the 25 patients’ ability to walk increased and walking became normal for five patients. Walking ability was worse for two patients. One patient experienced a vasovagal reaction during the procedure which may have been related to the lesion location. Minor complication rate was 23.7% and included 8 episodes of a small cement leakage into the soft tissue (resolved within 24 hours) and one episode of first-degree skin burns.

Radiofrequency ablation with percutaneous osteoplasty is a new treatment that shows promise for treating painful bone metastases. Although this study demonstrates its safety, efficacy, and feasibility, further study is needed with a larger number of patients.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Findings not generalizable
• Other limitations/explanation: All patients were from one medical center.

Radiofrequency ablation with percutaneous osteoplasty is a palliative care intervention that nurses should be aware of as they may be caring for patients who receive this treatment once additional scientific evidence is established. Nurses should be knowledgeable of potential complications that may result from the procedure (i.e., skin burns, cement leakage).