The objective of the study was to compare the efficacy and safety of 10% povidone-iodine and thoracoscopic talc insufflation for pleurodesis of recurrent malignant pleural effusions due to metastatic breast cancer.

Forty-two participants were randomized into two groups. Patients assigned to Group A received video-assisted thoracoscopic (VATS) drainage, mechanical adhesiolysis, and 4 g of talc poudrage, while the 20 patients assigned to Group B received VATS drainage, mechanical adhesiolysis, bedside pleurodesis with 20 mL of 10% povidone-iodine diluted in 30 mL of normal saline. Therapeutic thoracentesis was performed in all participants, and pleural fluid volume was recorded and sent for biochemical (pH, LDH, glucose), bacteriologic, and cytologic evaluation. All patients were scheduled for a follow-up every three months at which symptoms and chest x-rays were evaluated, and efficacy of pleurodesis was gauged on three levels: complete (absence of pleural fluid reaccumulation), partial (residual pleural fluid or reaccumulation that remained asymptomatic and not requiring thoracentesis), or failed (necessitating pleural procedures). Success was defined as a normal chest x-ray or radiologic reaccumulation of pleural fluid without recurrence of dyspnea or need for thoracentesis. Repeated ultrasound-guided thoracentesis was provided for patients with failed pleurodesis and reaccumulation of effusion at weekly intervals, and a PleurX^® catheter was offered for home management of effusions when required.

• The study reported on a sample of 42 patients.
• In Group A, the mean age was 48 years (SD = 9 years), and the range was 29–64 years.
• In Group B, the mean age was 50.2 years (SD = 7 years), and the range was 32–62 years.
• Data were not available to determine the percentage of males and females.
• Participants had malignant pleural effusion secondary to metastatic breast cancer.
• All patients either had either metastasis as their first presentation or had relapsed after chemotherapy during their follow-up.
• Patients were excluded from the study if they had a performance status greater than three, known allergies to iodine, a trapped lung, no change in the Medical Research Council (MRC) dyspnea scale after thoracentesis, pleural fluid pH less than 7.2 or glucose less than 60 mg/dL, and an extrathoracic metastasis.
• Both groups received the same protocol for adjuvant chemotherapy (i.e., 5FU, Adriamycin^®, and chlophosphamide (FAC), or docetaxel).
• No difference in preoperative demographic and clinical details between the two groups were noted.
   

This single-site study was conducted in an outpatient setting in the Department of Chest Medicine and Cardiothoracic Surgery in Cairo University Hospitals.
 

• Patients were in the transition phase after initial treatment.
• The study has clinical applicability for end-of-life and palliative care and late effects and survivorship.
   

The study was a prospective, randomized controlled trial.

• Medical Research Council (MRC) dyspnea scale to assess breathlessness
• Performance status scale (ECOG) to assess functional ability
• Diagnostic thoracentesis
   

Dyspnea and cough symptoms were improved in all patients after drainage and pleurodesis, and no mortality related to the procedure or perioperative mortality were observed. Survival rates between the two groups and totally at follow-up were 32 patients (76%) at eight months, 22 patients (52%) at two years, and 10 patients (23%) at four years. All had good outcomes with no bleeding complications and were discharged when both radiologic and clinical evidence confirmed complete resolution of pleural effusion. Group B experienced a significantly lesser post-procedural hospital stay (mean 5.7 days [SD = 2 days]) than Group A (mean 4.5 days [SD = 1.1 days]) (p = 0.009). During early follow-up in Group A, successful/complete response was achieved in 19 patients (87%), failure in 2 patients (9%), and partial response with radiologic reaccumulation at two months post-procedure but remaining asymptomatic during the 14 months’ follow-up. Early follow-up in Group B resulted in 17 (85%) complete response, no partial response, and three failures (15%) with recurrence of dyspnea at 33, 41, and 49 days respectively. No loculations were observed in Group B, thus a small-bore chest tube was placed and iodine was used again. In Group A, observed loculations were repeatedly aspirated with an ultrasound guide, and when repeated reaccumulation was experienced, an ultrasound-guided PleurX^® catheter was offered. No recurrence was detected at more than six months during follow-up, and no statistical difference between long-term success (four years) rates in Groups A (91%) and B (85%) were observed. Complications of pleuritic pain were observed in four participants of Group A (18%) but none in Group B, and fever was observed in four participants (18%) in Group A, and one participant (5%) in Group B.

Authors concluded that povidone-iodine pleurodesis is a safe and effective alternative to talc pleurodesis in the prevention of recurrent malignant pleural effusion at 30 days post-procedure. Additionally, while chest pain and fever are the most common adverse effects of pleurodesis, those in the iodine-povidone population (Group B) experienced less analgesic requirements and reports of fever, albeit at no statistical significance. Authors also emphasized that the dose of 10% povidone-iodine was administered in dilute form, thereby significantly increasing povidone safety with decreased toxicity when compared to other studies.

• The study had a small sample size, with less than 100 participants.
• The study results are only significant to a population of patients with malignant pleural effusion secondary to metastatic breast cancer; more research is warranted for efficacy among other population types.
• The clinical practice of providing mechanical adhesiolysis through the VATS procedure may have contributed to successful pleurodesis in both groups; true translation of this evidence would require performing a VATS procedure prior to the instillation of povidine-iodine, which is an uncommon practice. (Patients usually have a VATS procedure with talc insufflations or a chest catheter bedside procedure but not a surgical procedure followed by a bedside procedure.)
• Statistical analysis was limited by a lack of computed confidence intervals to safely exclude clinically relevant differences, as well as a lack of survival analysis.
   

Given its good success rate and fewer complications, povidone-iodine appears to be a successful, safe, and cost-effective alternative to talc pleurodesis for palliative management of malignant pleural effusion stemming from metastatic breast cancer.

The aim of the study was to evaluate the value of glutamic acid as a modifier in vincristine-induced neurotoxicity.

Children were randomized to treatment or placebo groups during adjuvant treatment with vincristine. Patients were evaluated weekly by physical examination. The treatment group received glutamic acid 1.5 g orally per day in three divided doses during a four-week induction with vincristine.

• The sample consisted of 94 pediatric patients (72% male and 28% female) with a mean age of 7.1 years (range of 3–18).
• The patients had acute lymphoblastic leukemia, non-Hodgkin lymphoma, or Wilms tumor.

The study was conducted at a single site in Egypt.

Phase of Care

• Active antitumor treatment

Clinical Applications

• Pediatrics
   

The study had a double-blind, randomized, placebo-controlled design.

• Achilles tendon reflex and patellar reflex were graded as normal, decreased, or absent.
• Parasthesis was recorded as absent, mild, moderate, and severe.
• Strength was assessed as normal, mild decrease, moderate decrease, and severe decrease.
   

Achilles and patellar reflexes were decreased at weeks 3 and 4 in more patients receiving placebo. Prevalence of mild parasthesias was greater in the placebo group at week 4. No severe parasthesias were recorded in the glutamic acid group compared to an incidence rate of 7.5% in the placebo group. The differences were not statistically significant.

The findings suggest that glutamic acid may be helpful in reducing vincristine-induced peripheral neuropathy symptoms in pediatric patients.

• Limitations include the small sample size (less than 100), measurement validity and reliability, and the findings not being generalizable.
• The method of grading reflexes and symptoms was not shown to be reliable, and physical examinations and grading were done by different physicians.
• Although the article states that patients were randomly assigned, it also states that the oncologist decided on the treatment, so assignment method is unclear.
• It is not stated whether there were any chemotherapy dose adjustment or delays.
• The article notes that “other treatments” were at the physician's discretion, so it is unclear if only glutamic acid was given for neuropathic effects.

 The findings suggest that glutamic acid may be helpful in managing peripheral neuropathy from vincristine; however, several study limitations exist. Additional well-designed research in this area is warranted.

To compare celecoxib versus diclofenac in mild to moderate depression in patients with breast cancer

Patients with breast cancer with mild to moderate depression and pain were randomized to receive celecoxib or diclofenac over a six-week period. Depression was evaluated at baseline, three weeks, and six weeks.

• N = 52
• MEAN AGE: 18-70 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients had breast cancer for more than 100 days; major depression according to ​Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), 4th edition; a score of less than or equal to 18 on the Hamilton Depression Rating Scale (HDRS); and mild to moderate pain, and needed an analgesic.
• OTHER KEY SAMPLE CHARACTERISTICS: No other psychotropic medication and no behavioral intervention therapy.

• SITE: Single site
• SETTING TYPE: Outpatient
• LOCATION: Tehran, Iran

• Single center, double-blind, controlled, parallel group

• DSM-IV-TR to diagnose
• HDRS
• Visual Analog Scale (VAS) mild to moderate pain (0-100) measured by need for analgesic

Fifty-two patients randomized with similar characteristics showed a significant reduction in HDRS score in celecoxib group by week six; however, none achieved a remission of symptoms. There was no significant difference in VAS score.

There was a greater antidepressant effect for celecoxib than for diclofenac by week 6.

• Small sample (less than 100)
• Risk of bias (no control group)
• Findings not generalizable
• Very short time frame; metastatic disease may have had an effect on results due to pain and prognosis

It is important to recognize that symptoms often present in clusters (pain/depression), and treatment of all symptoms are important to often achieve relief of any symptom.

To investigate the safety and efficacy of intrathecal dexmedetomidine with or without fentanyl

Patients were randomly assigned to one of three groups. The control group received 0.5% bupivacaine and saline intrathecally, the second group received bupivacaine and 5 mcg of dexmedetomidine, and the third group received bupivacaine, 5 mcg of dexmedetomidine, and 25 mcg of fentanyl intrathecally prior to anesthesia. All patients received 5 mg of oral diazepam the night before surgery. Pain was assessed immediately after surgery and at two, four, six, eight, 12, and 24 hours. Postoperatively, intravenous tramadol at 100 mg was given upon patient request or if pain scores were three or greater.

• N = 90  
• MEAN AGE = 44.31 years
• MALES: 30%, FEMALES: 70%
• KEY DISEASE CHARACTERISTICS: All patients were receiving major abdominal surgeries. Specific disease types were not reported.

• SITE: Single site  
• SETTING TYPE: Inpatient  
• LOCATION: Egypt

• PHASE OF CARE: Active antitumor treatment

Double-blinded, randomized, three-arm trial

• Visual Analog Scale (VAS) for pain severity
• Observers Assessment of Alertness/Sedation (OAA/S) scale
• Time to first request for analgesia
• Total analgesic consumption

There were no differences between groups in sedation scores or hemodynamic measures. Patients in the control bupivacaine-only group had significantly higher pain at baseline. Postoperative pain scores were lower among those who received dexmedetomidine compared to controls at 12 hours (p = 0.027), but there were no differences at any other time point. Time to first analgesic request was significantly longer in the dexmedetomidine and fentanyl group, and this time was longer in both dexmedetomidine groups compared to the control (p < 0.001). Total tramadol consumption also was lower among those who received dexmedetomidine (p < 0.001). In general, there was a lower prevalence of adverse effects among those receiving dexmedetomidine.

The intrathecal administration of 5 mcg dexmedetomidine increased the efficacy and duration of postoperative analgesia. The addition of fentanyl did not have a significant additive effect.

• Small sample (< 100)

The provision of preoperative intrathecal anesthetics and analgesics can improve postoperative pain control. This study demonstrated that the addition of dexmedetomidine to bupivacaine improved the postoperative effectiveness and duration of analgesia, resulting in less need for other analgesics. Nurses can advocate for the consideration of this type of approach for patients undergoing major surgery to reduce procedure-related pain.

To evaluate the effects of group therapy on anxiety and depression

Acceptance and commitment therapy (ACT) is described as a type of “third wave” of cognitive behavioral therapy that focuses on values and goals clarification and acceptance-based behavioral strategies and mindfulness processes. Participants were randomly assigned to experimental and control groups. The experimental group had ACT held in eight sessions of 90 minutes during four consecutive weeks. These were provided in a group setting. Study measures were obtained at baseline and after the intervention.

• N= 30
• MEAN AGE = 47.2 years (range = 29-59)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer, but stages varied.  Standard therapy was completed.

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: Iran

• PHASE OF CARE: Transition phase after active treatment

Randomized, controlled trial

• Beck Depression Inventory
• Beck Anxiety Scale

Anxiety and depression scores declined in the experimental group, while increasing in the control group. These differences, however, were not statistically significant (p = 0.000).

Findings suggest that a psychoeducational intervention based on acceptance and commitment therapy can be of benefit in reducing anxiety and depression among women with breast cancer.

• Small sample (less than 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Other limitations/explanation: There is no description of the control condition, and apparently no attentional control. Baseline anxiety and depression scores were higher in the experimental group, and other studies have shown that interventions can have a greater effect for those with higher anxiety and depression initially.

This type of psychoeducational intervention may be of benefit to reduce anxiety and depression in women with breast cancer. It is not clear to what extent results here were an effect of the protocol used or the participation in group sessions, which could have been supportive.  Psychoeducational interventions are generally low-risk and relatively low-cost approaches that may be of benefit to patients.

• FINAL NUMBER STUDIES INCLUDED = 60 
• TOTAL PATIENTS INCLUDED IN REVIEW: Not able to determine the total number of patient is this review
• KEY SAMPLE CHARACTERISTICS: Characteristics spanned a wide variety of diagnoses that included cancer, dyspepsia, and gastroesophageal reflux disease. 

Twelve studies looked at rikkunshito’s effects on anorexia in subjects with cancer. Three studies utilized human subjects. These studies looked at patients receiving cisplatin for unresectable/relapsed gastric cancer and gemcitabine for pancreatic cancer with ascites. The results showed that rikkunshito improved anorexia in 19 patients receiving docetaxel/5-FU/cisplatin. When evaluated for nausea, mood, and activities of daily living, scores in these metrics were significantly lower in the rikkunshito group compared to controls. In a crossover design, the effects of rikkunshito on cisplatin-induced anorexia were studied, which demonstrated an increase in oral intake, no decrease in ghrelin levels, and a lower grade of anorexia in patients taking rikkunshito compared to when those patients were not taking rikkunshito. In a retrospective study of 39 patients who were treated with gemcitabine, improvement in anorexia was noted as well as increased survival. In the studies of anorexia, models utilizing animals revealed improved food intake with increased ghrelin levels that were noted along with improved survival. Rikkunshito was combined with various western agents in these studies and was shown to improve gastrointestinal side effects/symptoms and not affect the effects of the agents (e.g., SSRIs, antimicrobial agents, antiparkinson agents). There was no indication for any effect on CYP isoenzymes or P-gp.

Rikkunshito combined with western anticancer medicines has been shown to improve appetite by increasing ghrelin levels, thereby reducing anorexia.

All studies were conducted in Japan where Kampo medicine is used frequently and is readily available for use. There were very few human studies conducted; the majority of studies utilized animal subjects.

Rikkunshito appears to be a promising medication to improve anorexia, but there is inadequate data to recommend this agent at this time. Additional studies utilizing human subjects and a variety of anticancer medications as well as cancer diagnoses need to be conducted. In addition, studies are needed to evaluate the use of rikkunshito for the management of gastrointestinal symptoms in other diagnoses (e.g., depression, Parkinson’s, gastroesophageal reflux disease).

To evaluate the use of honey and royal jelly on fatigue in individuals undergoing treatment for cancer

In this study, the intervention group received processed honey and royal jelly. The control group received pure honey. Each group consumed 5 ml twice daily for four weeks. Assessments of outcome measures were completed at baseline, two weeks, and four weeks after the intervention.

• N = 52   
• AGE = 54.8 years
• MALES: 40%, FEMALES: 60%
• CURRENT TREATMENT: Chemotherapy, radiation, combination radiation and chemotherapy, other
• KEY DISEASE CHARACTERISTICS: Solid tumors (breast, prostate, and gastrointestinal related)

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Iran

PHASE OF CARE: Active antitumor treatment

This was a double-blind, randomized, controlled clinical trial in which participants were randomized to one of two groups (intervention group = processed honey and royal jelly; control group = pure honey).

Visual analog scale for fatigue (VAS-F) and fatigue severity scale

Numeric fatigue ratings in the intervention group were significantly less than those reported in the control group (p < 0.001) at the week 2 and week 4.

The use of processed honey and royal jelly to manage cancer-related fatigue warrants further investigation into the mechanisms and efficacy of use.

Small sample (< 100)

No side effects were noted in this study with the use of a dietary supplement. The results suggested that honey with royal jelly may help alleviate chemotherapy-related fatigue.

A self-paced, progressive, home-based exercise program (walking exercise versus usual care) was used. Individualized walking was based on age, level of fitness, and history of exercise. The program was a brisk, incremental, 20- to 30-minute walk, followed by a 5-minute slow walking cool-down, four to five times per week for six weeks. Outcomes were exercise, fatigue, physical functioning, emotional distress, and sleep.

• The sample was comprised of 46 females.
• Mean age was 49 years.
• Of the patients, 87% were Caucasian and 72% had stage I breast cancer and were undergoing radiotherapy.

• Two university teaching hospitals
• Instructions were given at the institution, but the intervention was performed at home.
• Southeastern United States

Patients were undergoing the active treatment phase of care.

The study used a two-group, controlled, pre-/posttest experimental design.

• Symptom Assessment Scale (SAS)
• Piper Fatigue Scale (PFS)
• 12-minute walk test
• Sociodemographic information

Women who exercised regularly reported less difficulty sleeping than the control group.

• Only the first patient received random assignment. Subsequent patients were alternately assigned to the usual care or exercise groups.
• A diffusion effect was possible for exercisers in the usual care group.
• The study had a small sample size.
• The study lacked control over the intervention in the home.
• Patients had to adhere to a five-day-a-week regimen.
• Exercise physiologist consultation is needed.
• RNs must be trained in delivering the intervention.
• The study should be supervised by a principal investigator.

Caution:  maintain safety while exercising.

To investigate the effect of combined decongestive therapy (CDT) and pneumatic compression pump on upper-limb lymphedema indicators (circumference, volume, and shoulder range of motions) in patients with breast cancer-related lymphedema

The intervention was completed in two phases. In the first phase, the therapeutic phase, CDT and compression pumping was performed by the one researcher at the clinic. Each session included manual lymphatic drainage for 30–40 minutes. The affected upper limb was then placed in the compression pump for 15 minutes and bandaged with multilayer compression bandages, followed by remedial exercises. Also during the first phase, written and verbal information were given regarding skin and nail care, care of the bandaging and practical training in manual lymphatic drainage, how to bandage the upper limb, and remedial exercises. In the second phase, the maintenance phase, patients performed CDT daily at home. The first phase included three weekly sessions for four weeks; each session lasted 60–90 minutes. The second phase included daily CDT for four weeks. Patients were evaluated at baseline and four and eight weeks after the intervention.

• The study sample (N = 21) was comprised of 100 femal patients with breast cancer-related upper-limb lymphedema.
• Mean age ranged from 35–70 years.
• All patients were at least one year since axillary node dissection and had not received CDT.

The study took place at the Shahid Mottahari Therapeutic Center in Shiraz, Iran.

The study has clinical applicability for late effects and survivorship.

The study used a pre-post design.

• Measuring tape was used to measure circumference.
• Volume was measured using water displacement.
• Range of shoulder joint motions was measured using a goniometer.

The mean difference in circumference of the two upper limbs in all areas at different phases of study decreased significantly (p < 0.05). The difference in mean volume between the two upper limbs four and eight weeks after the intervention were smaller than before the intervention (p < 0.001). Mean range of flexion (p < 0.001), extension (p < 0.004), abduction (p < 0.001), and external rotation (p < 0.001) increased four and eight weeks after the intervention.

Combined CDT and pneumatic compression pump reduce mean volume and mean circumference of the breast cancer-related upper-limb lymphedema and increase shoulder joint range of motion.

• The sample size was small, with less than 30 participants.
• The study had a risk of bias because of no control group or random assignment.
• Unintended interventions or applicable interventions were not described and would influence results.
• The author did not provide the time (how many minutes) of daily CDT performed by patients in the second phase.
• No information is provided regarding the compression pump.  

Nurses can play a key role in providing rapid and timely interventions to reduce the severity of lymphedema (e.g., CDT skills and use of compression pump) and patient education regarding self-care and self-management of lymphedema.

Random assignment occurred in a 2:1 ratio to the intervention group or control group after stratification by treatment (chemotherapy or antiestrogen therapy). The yoga intervention consisted of twelve 1.5-hour weekly classes held at three locations within the cancer center. Participants were permitted to attend more than one class per week, with such activity documented. The yoga intervention was developed for use with patients with breast cancer by one of the study authors who was an oncologist and a certified yoga instructor. The intervention was based on Hatha yoga stretches and poses, breathing exercises, and meditation. All exercises were performed in a seated or reclined position. Patients were asked to practice yoga at home daily and were given an audiotape/CD for guidance in their home practice.

• Oncology outpatients were recruited from oncology clinics at a university medical center and from several private clinics between 2001 and 2005.
• The sample was comprised of 128 patients with breast cancer.
• Mean age was 54.81 years (range 28–75).
• Of the patients, 42% were Black, 31% were Hispanic, 23% were White, 76% had high school education or less, 69% were not married, 45% had stage I, and 53% had undergone lumpectomy.
• Of 164 women with breast cancer who consented, 128 (78%) completed the baseline and main follow-up (three-month) assessments.

Patients were undergoing the active treatment phase of care.

The study used a randomized, wait-list control design.

Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F)

No significant difference was found in fatigue change scores from baseline to three-month follow-up between the intervention and wait-list control groups. Both groups were significantly fatigued compared with normative values for the FACIT-F. Subanalysis of the change scores only among the subgroup of patients not on chemotherapy (n = 71) also failed to demonstrate an effect of the yoga intervention on fatigue. However, adherence analysis suggested that participants in the intervention group who were highly adherent with the yoga intervention had significantly improved in fatigue compared with those in the intervention group who were less adherent with the yoga intervention. The primary reason for attrition was lost to follow-up (15%), with attrition similar between the intervention (22%) and control (21%) groups. Those who dropped out were significantly more likely to be younger.

• The study had a small sample size (intervention group, n = 84).
• One can speculate that the effects of the intervention may have been obscured by the relatively high level of fatigue of the participants. In support of this possibility is the fact that fatigue was a statistically significant predictor of yoga class attendance.
• Yoga may be less feasible for patients who are on active treatment with radiation or chemotherapy or those who are already fatigued—adherence analysis revealed that greater fatigue, younger age, receiving radiotherapy, and not being on antiestrogen therapy together explained 40% of the variance in attendance at weekly yoga classes.