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Otte, J. L., Carpenter, J. S., Zhong, X., & Johnstone, P. A. (2011). Feasibility study of acupuncture for reducing sleep disturbances and hot flashes in postmenopausal breast cancer survivors. Clinical Nurse Specialist, 25, 228–236.

Study Purpose

To evaluate the feasibility of acupuncture as a treatment for concurrent hot flashes (HFs) and sleep disturbances.

Intervention Characteristics/Basic Study Process

  • This was an eight-week study using certified community acupuncture providers for three acupuncture treatments over a two-week period per patient.
  • Wrist actigraphy and sternal skin conductance was used for measuring HF occurrence and duration.
  • Completion of questionnaires was required at baseline and weeks 5 and 8.
  • Self-reported symptom data were gathered during treatment and each week at follow-up.

Sample Characteristics

  • The sample was comprised of 10 female patients. 
  • Patients were 18 years or older; mean age was 53 years.
  • Patients had breast cancer stage 1; a possible other stage was not defined.
  • Patients were perimenopausal/postmenopausal.
  • Patients could not change sleep or HF medication during study.

Patients were included if they

  • Reported sleep disturbances over the past month
  • Had daily HFs
  • Lived within a 100-mile radius of the study site
  • Spoke English
  • Were diagnosed with nonmetastatic breast cancer
  • Had no history of other cancers
  • Were at least three months postcompletion of surgery, radiotherapy, and chemotherapy.

Setting

  • Multisite   
  • Outpatient   
  • University

Phase of Care and Clinical Applications

  • Patients were undergoing the transition phase after initial treatment.
  • The study has clinical applicability for late effects and survivorship.

Study Design

The study used a quasiexperimental, single-group, nonrandomized design.

Measurement Instruments/Methods

  • Protocol for acupuncture points
  • Demographic questionnaire
  • Disease and treatment information
  • Acupuncture session notes
  • 6-item Devilly and Borkovec Outcome/Expectancy Credibility Questionnaire (DBO/ECQ)
  • Wrist Actigraphy and Sternal Skin Conductance Monitoring Biolog model 3991
  • Sleep diary

Results

Ten breast cancer survivors (BSCs) completed baseline, and two withdrew after the last baseline assessment. The remaining eight BSCs completed all time points. There was no significant difference among acupuncture points used per patient for the three treatments or the four providers. Sessions were mainly conducted at a single clinic. The study described patients as having high outcome expectations for acupuncture effectiveness and its acceptability. Sleep patterns were affected:  sleep latency increased and time spent awake after sleep onset decreased. The average number of HFs decreased.

Conclusions

Expectations for and credibility and acceptability of acupuncture in managing vasomotor and sleep symptoms were high for the BSCs.The study demonstrated minimal improvement in total sleep time and some sleep latency improvement immediately following completion of acupuncture sessions but not at week 8 (not a sustainable effect); waking after sleep onset improved.

Limitations

  • The study had a small sample size, with less than 30 patients.
  • The majority of the patients enrolled were not taking a hormone modulator at the time of enrollment; therefore, the authors were unable to extrapolate the results found here to apply to BSCs using aromatase inhibitors or tamoxifen in treating their breast cancer.
  • The number of acupuncture treatments was limited to three over two weeks.
  • Reproducible results were limited because the study mainly occurred at one site with one acupuncturist.
  • No control group was used for comparison to the intervention of acupuncture.

Nursing Implications

The study showed that women may be amenable, especially highly motivated women, to pursuing acupuncture as a nonpharmacological approach to managing HFs. Further investigations with larger sample sizes are needed to note if there are any correlations with socioeconomic/cultural influences for the acceptability of acupuncture and to compare acupuncture to another intervention for the control of HFs/sleep quality.

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Oton-Leite, A.F., Silva, G.B., Morais, M.O., Silva, T.A., Leles, C.R., Valadares, M.C., . . . Mendonca, E.F. (2015). Effect of low-level laser therapy on chemoradiotherapy-induced oral mucositis and salivary inflammatory mediators in head and neck cancer patients. Lasers in Surgery and Medicine, 47, 296–305.

Study Purpose

To evaluate the effect of low-level laser therapy (LLLT) on the severity of oral mucositis (OM) and the release of salivary molecules (TNF~a, IL-1b, IL6, IL10, TGF-b, EGF< FGF< VEGF< MMP2/TIMP2, and MMP9/TIMP2) during chemoradiation in patients with head and neck cancer

Intervention Characteristics/Basic Study Process

All patients received radiation therapy (RT) treatments over seven weeks with a minimum dose of 50 Gy to the oral cavity and cisplatin at 100 mg/m2 every 21 days. Patients were randomized to two groups. The experimental group received LLLT (660 nm, 25 mw output power in a continuous wave at a fluence of 6.2 J/cm2 energy per point of 0.24 J for 10 seconds per point) while the control group received sham therapy (patients wore glasses so they would not know if laser light was on or not). LLLT and sham therapies were administered by the same operator. All patients received standard oral healthcare, antifungals, and analgesics when needed. OM was evaluated weekly by the same trained dentist who was blinded to the randomization. Saliva samples were obtained at one point before chemoradiotherapy and at three points during the treatment on days 7, 21, and 35 of RT. Spitting specimens and unstimulated saliva collections were obtained, and both were analyzed for salivary inflammatory mediator levels.

Sample Characteristics

  • N = 25  
  • AGE = 10 were aged greater than 60 years, and 15 were aged less than 60 years
  • MALES: 84%, FEMALES: 16%
  • KEY DISEASE CHARACTERISTICS: Head and neck cancer (nine oral cavity, seven pharynx, and nine oropharynx)
  • OTHER KEY SAMPLE CHARACTERISTICS: In the laser group, three patients died during the course of the study, two from pneumonia and one from hemorrhagic complications (not explained). In the control group, two patients dropped out of treatment. The sample started with 30 patients, and only 25 completed treatment.

Setting

  • SITE: Single site  
  • SETTING TYPE: Unknown
  • LOCATION: Brazil

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active treatment

Study Design

Randomized, double-blinded, placebo-controlled clinical trial

Measurement Instruments/Methods

  • The severity of OM was rated according to the National Cancer Institute (NCI) and World Health Organization (WHO) mucositis grading scales.

Results

OM grades in both scales were significantly lower in the laser group than in the control group at RT sessions 7, 21, and 35 (p < 0.05). In the control group, levels of IL-6 followed the clinical course of OM until the peak (ulcerative phase) at RT session 21. In the LLLT group, salivary IL-6 concentrations decreased significantly at the end of RT (session 35, p = 0.032). Regarding the proinflammatory cytokines IL-1B and TNF-a, there was no statistically significant difference between the two groups. In regard to the anti-inflammatory cytokines IL-10 and TGF-b, no statistically significant difference between the groups was found. For the growth factors analyzed, FGF levels decreased after the ulcerative phase of OM in the laser group. This was statistically significant at session 35, corresponding to wound healing (p = 0.038).

Conclusions

LLLT reduced OM in the experimental group when compared to the control group. This study added to the growing body of literature demonstrating that LLLT is an effective intervention for OM in patients receiving treatment for cancer.

Limitations

  • Small sample (< 30)
  • Key sample group differences that could influence results
  • Other limitations/explanation: Six patients in the laser group had T3 or T4 disease while 10 patients in the control group had T3 or T4 disease. There was no mention of comorbid conditions such as diabetes, which might affect healing time and salivary concentrations. There were no limits on medications taken by the participants, which could have affected the outcomes.

Nursing Implications

Reducing OM can have a distinct impact on patients' quality of life, pain control, and ability to complete chemoradiation in a timely manner. Nurses have daily interactions with patients to assist them through the completion of therapy. This study contributed to the growing body of literature demonstrating that LLLT is an effective intervention for OM.

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Othman, A.H., & Zaky, A.H. (2014). Management of hot flushes in breast cancer survivors: Comparison between stellate ganglion block and pregabalin. Pain Medicine, 15, 410–417.

Study Purpose

To compare stellate ganglion block and pregabalin in terms of efficacy and safety for the treatment of hot flashes in survivors of breast cancer

Intervention Characteristics/Basic Study Process

Patients were randomized to two groups. Stellate ganglion block at the anterolateral aspect of the C7 vertebra on the right side under fluoroscopy was done for 20 women experiencing hot flashes, and 20 other women received 75 mg pregabalin twice daily. Monthly symptom questionnaires were obtained at baseline and for the following three months.

Sample Characteristics

  • N = 40  
  • MEAN AGE = 21 and older, with at least a six-month life expectancy
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Women with a diagnosis of breast cancer. All had received chemotherapy in the past. Subjects were not included in the study if they were currently receiving antineoplastic chemotherapy, androgens, estrogens, or progesterone analogs. The use of other agents for treating hot flashes, including vitamin E, antidepressants, or gabapentin, was not allowed prior to study initiation.
  • OTHER KEY SAMPLE CHARACTERISTICS: Subjects experienced hot flashes for at least a month prior to study. They could receive tamoxifen, raloxifene, or aromatase inhibitors. No subject had a hysterectomy.

Setting

  • SITE: Not stated/unknown    
  • SETTING TYPE: Not specified    
  • LOCATION: Not specified

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship

Study Design

  • Prospective single blind

Measurement Instruments/Methods

All of the participants completed daily hot flash diaries that included four levels of severity of hot flashes (mild, moderate, severe, and very severe). The hot flash score was not selective to hot flashes at night or during the day; instead, it looked at the total number of hot flashes and their intensity during the 24-hour period. The side effects of pregabalin were assessed.

Results

The stellate ganglion block group had a significant (p < 0.05) decline in the frequency of mild, moderate, and very severe levels and total hot flashes in comparison with the pregabalin 75 mg twice daily group during the three months of follow-up period.

Conclusions

During this study with a short follow-up of three months in a small group of subjects, stellate ganglion block had superior efficacy in the management of hot flashes in survivors of breast cancer.

Limitations

  • Small sample (less than 100)
  • Measurement validity/reliability questionable 
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs

Nursing Implications

Randomized trial exploring the effectiveness of stellate ganglion block and pregabalin suggests stellate ganglion is more effective in decreasing hot flashes. The sample size is small (n = 40); there is limited information about how the hot flash score was calculated.  Follow-up period was three months. More research on both interventions is needed.

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Otani, H., Morita, T., Uno, S., Yamamoto, R., Hirose, H., Matsubara, T., . . . Sasaki, K. (2014). Effect of leaflet-based intervention on family members of terminally ill patients with cancer having delirium: Historical control study. American Journal of Hospice and Palliative Medicine, 31, 322–326. 

Study Purpose

To assess the effects of an informational leaflet about delirium on family-perceived distress, the need for improvement in professional care for delirium, and the knowledge about the causes of delirium in patients during the end of life

Intervention Characteristics/Basic Study Process

Palliative care practitioners distributed an informational leaflet on delirium as part of their routine care of patients. Families of patients who experienced delirium at the end of life were then contacted by mail six months after the patient had died to complete a questionnaire about their experience.

Sample Characteristics

  • N = 113   
  • MEAN AGE = 74 years
  • MALES: 61%, FEMALES: 39%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Predominately spouse of patient (42%) or child of patient (36%)

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Japan

Phase of Care and Clinical Applications

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

Study Design

Single-arm, historical control

Measurement Instruments/Methods

A questionnaire was developed for the study that measured family distress (single item), the need for improvements in professional care for delirium (single item), and knowledge of the causes of delirium (single item). A Likert-type scale was used for each question.

Results

The intervention group had a better understanding of certain aspects of the causes of delirium (p < 0.001). No difference was reported between the historical control and intervention groups in terms of the levels of family-perceived distress or the need for improvement in professional care for delirium.

Conclusions

An educational leaflet may improve family members' knowledge and understanding about some of the causes of delirium at the end of life.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement validity/reliability questionable
  • Low return rate
  • Potential for recall bias among both groups surveyed

Nursing Implications

Written information about expected symptoms, such as delirium, may be helpful in increasing family members' knowledge.

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Otake, A., Yoshino, K., Ueda, Y., Sawada, K., Mabuchi, S., Kimura, T., . . . Kimura, T. (2015). Usefulness of duloxetine for Paclitaxel-induced peripheral neuropathy treatment in gynecological cancer patients. Anticancer Research, 35, 359–363.

Study Purpose

To explore the potential efficacy of duloxetine for use against chemotherapy-induced peripheral neuropathy (CIPN) among patients with gynecologic cancers receiving paclitaxel

Intervention Characteristics/Basic Study Process

The medical records of patients being treated with duloxetine were evaluated retrospectively. The severity of symptoms before and after duloxetine administration was evaluated according to documented patient responses as either responders (symptoms dropped more than 1 grade) or non-responders (patients had a stable or worsening grade of neuropathy). A maintenance dose of duloxetine at 20 mg per day was given in 18 cases, and 40 mg per day was given in seven cases. In 12 cases, duloxetine administration began during chemotherapy. In 13 cases, it was started after chemotherapy (in four of these cases, one year after the completion of chemotherapy).

Sample Characteristics

  • N = 25  
  • MEDIAN AGE = 62 years (range = 40–77 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Ovarian, corpus, and cervical cancers; all were receiving paclitaxel and carboplatin with or without epirubicin; median accumulated dose of paclitaxel was 1,805 mg per body; accumulated median dose of carboplatin was 3,368 mg
  • OTHER KEY SAMPLE CHARACTERISTICS: Prior to duloxetine, medications used in some patients included goshajinkigan, pregaabalin, vitamin B12, and SSRIs.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care 

Study Design

Retrospective, observational trial

Measurement Instruments/Methods

  • National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 4.0

Results

56% of patients responded to duloxetine and 44% did not respond. An analysis of demographic, disease, and treatment-related variables showed no significant association between any of these factors and the effectiveness of duloxetine. Adverse events were mild, and duloxetine generally was well tolerated. Overall, older patients tended to be less responsive to duloxetine.

Conclusions

The majority of patients responded to duloxetine, suggesting that in some patients, it can be helpful in managing the symptoms of CIPN.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement validity/reliability questionable

 

 

Nursing Implications

The findings of this study suggest that duloxetine may be helpful for some patients for the prevention and management of CIPN. However, it was not effective in all cases. The study's findings were limited by its design. Additional research studies exploring effective dosages, the types of CIPN that respond to duloxetine, appropriate timing, and effects of duloxetine on the full range of CIPN symptoms rather than just pain are needed.

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Ota, M., Tatsumi, K., Suwa, H., Watanabe, J., Watanabe, K., Osada, S., . . . Endo, I. (2014). The effect of pyridoxine for prevention of hand-foot syndrome in colorectal cancer patients with adjuvant chemotherapy using capecitabine: A randomized study. Hepato-Gastroenterology, 61, 1008–1013. 

Study Purpose

To assess the effectiveness of pyridoxine for the prevention of hand-foot syndrome in patients receiving capecitabine

Intervention Characteristics/Basic Study Process

Patients were randomized to receive pyridoxine or not. Pyridoxine 30 mg was given three times daily during chemotherapy. The primary study endpoint was hand-foot syndrome of grade 2 or higher.

Sample Characteristics

  • N = 60   
  • MEAN AGE = 62.1 years
  • MALES: Not provided, FEMALES: Not provided
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Colorectal cancer

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Open-label, randomized, controlled trial

Measurement Instruments/Methods

Common Terminology Criteria for Adverse Events (CTCAE)

Results

Sixty percent of patients had at least grade 2 hand-foot syndrome. No differences existed between study groups.

Conclusions

Pyridoxine was not shown to have an effect for the prevention of hand-foot syndrome.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)

 

Nursing Implications

Pyridoxine was not shown to have a preventive effect on the development of hand-foot syndrome. There are few interventions studied or shown to be effective for the prevention of this complication of cancer treatment. Ongoing research is needed to determine the effective approaches for the management of skin and nail toxicities.

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Ost, D.E., Ernst, A., Grosu, H.B., Lei, X., Diaz-Mendoza, J., Slade, M., . . . AQuIRE Bronchoscopy Registry. (2015). Therapeutic bronchoscopy for malignant central airway obstruction: Success rates and impact on dyspnea and quality of life. Chest, 147, 1282–1298. 

Study Purpose

To measure the technical success of therapeutic bronchoscopy and its impact in improving dyspnea and quality of life among patients with malignant central airway obstruction

Intervention Characteristics/Basic Study Process

Data from the AQuIRE (American College of Chest Physicians Quality Improvement Registry) for 1,115 procedures on 947 patients undergoing therapeutic bronchoscopy from January 2009–February 2013 were used for this study. Primary outcome data were defined as greater than a 50% opening of airway lumen. A smaller subset (N = 187) of centers collected pre- and postprocedure (30 days) secondary outcome data looking at dyspnea improvement after bronchoscopy as measured via Borg scores and health-related quality of life (HRQOL) measured via the SF-6D.

Sample Characteristics

  • N = 947   
  • AGE = 62.8 years
  • MALES: 55.6%, FEMALES: 44.4%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Of all participants, 71.7% had primary lung cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: The sample size for clinical outcome data was 187.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Cleveland Clinic Foundation, Cleveland, OH; the Penn State Cancer Institute, Hershey, PA; the University of Illinois Hospital and Health Sciences Center, Chicago, IL; the Department of Pulmonary and Critical Care Medicine, Boston University, Boston, MA; the Department of Interventional Pulmonology, Chicago Chest Center, Chicago, IL; the Department of Pulmonary and Critical Care, Baylor College of Medicine, Houston, TX; the Department of Internal Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine, Duke University Medical Center, Durham, NC; the Department of Pulmonary and Critical Care Medicine, Johns Hopkins Hospital, Baltimore, MD; the Department of Pulmonary, Critical Care, and Sleep Medicine, University of Cincinnati, Cincinnati, OH; and the Department of Pulmonary and Critical Care Medicine, University of Calgary, Calgary, AB, Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Elder care, palliative care

Study Design

  • Retrospective data analysis for technical outcomes
  • Prospective trial to evaluate clinical outcomes

Measurement Instruments/Methods

  • SF-6D
  • Borg Rating of Perceived Exertion Scale score 
  • Technical success was based on anatomic criteria defined as a brochoscopically reopening of the airway lumen to greater than 50% of the normal diameter, and the airway had to connect to a viable area of distal lung. All clinical outcomes were assessed by the attending physician using standardized definitions from a code book developed by the American College of Chest Physicians Quality Improvement Registry, Evaluation and Education (AQuIRE) program, to evaluate therapeutic bronchoscopy for malignant central airway obstruction.

Results

The technical success rate of the therapeutic bronchoscopies was 90%–98%. Participants with an American Society of Anesthesiology score greater than 3 with renal failure, primary lung cancer, left mainstem disease, and tracheoesophageal fistula were linked with failure. In addition, participants who were heavy smokers and who had multiple cancers and lobar obstruction showed a smaller improvement than the other participants. A 3.9% complication rate was observed, 0.5% of the patients died postprocedure, and the 30-day mortality rate was 15%. Secondary outcome data post-procedure showed that 48% of the patients had a clinically significant improvement in dyspnea, dyspnea stayed the same in 43% of patients, and 9% had worse dyspnea. HRQOL improved postprocedure for 42% of patients. Those that had worse baseline dyspnea scores tended to have the greatest improvement. Those with lobular obstructions had smaller measures of improvement in HRQOL.

Conclusions

The use of therapeutic bronchoscopy for the treatment of malignant central airway obstruction had a high technical success rate. More importantly, patients showed significant improvement in their subjective rating of dyspnea and in HRQOL. Having clinical outcome data assists in the process of weighing potential risks versus benefits of this procedure. Given that some of the patients with the worst dyspnea at baseline ultimately had the greatest benefit, these patients should be considered for therapeutic bronchoscopy and not assumed to be too sick to benefit.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no random assignment)
  • Key sample group differences that could influence results
  • Findings not generalizable
  • No standard method of patient selection or standardization of procedure, as all clinical decisions were at the discretion of the individual performing the therapeutic bronchoscopy
  • Significant variations in practice patterns existed in different centers and locations of care.
  • Technical success rates were determined by the individual performing the procedure, and bias may have existed.

Nursing Implications

To educate and advocate for patients undergoing therapeutic bronchoscopies, nurses must be knowledgeable about the different types, purpose, indications, and potential risks and benefits of each. The technical success of the procedure is not sufficient enough in measuring the overall benefit to the patient; quality of life and palliation of dyspnea outcomes must also be considered.

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Ostuzzi, G., Benda, L., Costa, E., & Barbui, C. (2015). Efficacy and acceptability of antidepressants on the continuum of depressive experiences in patients with cancer: Systematic review and meta-analysis. Cancer Treatment Reviews, 41, 714–724.

Purpose

STUDY PURPOSE: To assess efficacy and acceptance of antidepressants on depression in patients with cancer
 
TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, CENTRAL, PsycINFO, and hand searches on international websites for regulatory agencies
 
KEYWORDS: Not provided
 
INCLUSION CRITERIA: Trials comparing antidepressants with inactive control groups, randomized trials, published and unpublished work, any patients receiving antidepressants, and participants with major depressive disorder, adjustment disorder, sythymic disorder, or depressive symptoms

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 4,587
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane risk of bias tool

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 21, and 19 in meta-analysis
  • TOTAL PATIENTS INCLUDED IN REVIEW = 2,007
  • SAMPLE RANGE ACROSS STUDIES: 19-549
  • KEY SAMPLE CHARACTERISTICS: Varied tumor types, ages ranged from 18-89 years

Results

Antidepressants were effective in reducing distressing symptoms (SMD = -0.229, p = 0.018) and major depression or depressive symptoms (SMD = -0.285, p = 0.001).  All types of antidepressants showed some efficacy, although tricyclic antidepressants did not show efficacy across two small studies. SSRIs and manserin were effective. Quality of life measures were also improved. There was significant heterogeneity. Analysis showed significant efficacy was correlated with length of follow up (p < 0.001). Antidepressants did not differ from placebo in terms of acceptability, using drop-out rate as a proxy of acceptability.

Conclusions

Antidepressants of all types demonstrated overall efficacy for improvement in depressive symptoms as well as other distressing symptoms. SSRIs and manserin showed the best results

Limitations

Overall quality of reports was graded as low to moderate. Several studies included funding by drug companies, suggesting sponsorship bias as the funder role was not described.  There was significant heterogeneity

Nursing Implications

Findings from this analysis show that antidepressants, particularly SSRIs and manserin, were tolerable and effective in reducing depressive symptoms in patients with cancer. Findings also suggest that efficacy may increase over time, pointing to the potential need for sufficient duration of treatment. It is important that nurses screen for symptoms of depression among patients with cancer, and facilitate relevant treatment.

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Ostuzzi, G., Matcham, F., Dauchy, S., Barbui, C., & Hotopf, M. (2015). Antidepressants for the treatment of depression in people with cancer. Cochrane Database of Systematic Reviews, 6, CD011006. 

Purpose

STUDY PURPOSE: Assess effects of antidepressants among people with cancer for treatment of depression

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, CENTRAL, and PsycINFO and hand searching of drug approval agencies
 
KEYWORDS: Extensive lists of search terms per database are provided
 
INCLUSION CRITERIA: Randomized trials comparing any antidepressant with placebo or another antidepressant. Adult patients 
 
EXCLUSION CRITERIA: Trials in which antidepressants were compared to another agent such as stimulants, antipsychotics, etc.

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 4,498
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane risk of bias assessment

Sample Characteristics

  • TOTAL PATIENTS INCLUDED IN REVIEW = 861
  • FINAL NUMBER STUDIES INCLUDED = 9, with 7 used in meta-analysis
  • SAMPLE RANGE ACROSS STUDIES: 35-93
  • KEY SAMPLE CHARACTERISTICS: Majority were in patients with breast cancer

 

Results

There was no differences between antidepressants as a class and placebo in five RCTs, no difference between groups comparing different antidepressants, and no difference in drop-out rates between placebo and antidepressants

Conclusions

The findings did not provide strong evidence for efficacy of antidepressants.

Limitations

Study quality was generally low with unclear risk of bias in multiple aspects of the study design and implementation. In five studies, risk of bias due to conflict of interest was questionable. There was no difference found between SSRIs and tricyclic antidepressants. Studies included were all conducted prior to 2009.

Nursing Implications

This particular analysis did not demonstrate efficacy of antidepressants in patients with cancer for management of depressive symptoms. There were multiple limitations in this analysis due to the low quality of the studies included.

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Osterlund, P., Ruotsalainen, T., Korpela, R., Saxelin, M., Ollus, A., Valta, P., … Joensuu, H. (2007). Lactobacillus supplementation for diarrhoea related to chemotherapy of colorectal cancer: A randomised study. British Journal of Cancer, 97(8), 1028–1034.

Study Purpose

To assess the effect of Lactobacillus and fiber supplementation on tolerability of treatment with chemotherapy containing 5-fluorouracil (5-FU) and to compare the tolerability and frequency of diarrhea with the Mayo regimen (bolus 5-FU) to that of the simplified de Gramont regiment (bolus plus continuous 5-FU)

Intervention Characteristics/Basic Study Process

Postoperative colorectal cancer (CRC) patients were randomly assigned to receive adjuvant chemotherapy monthly (Mayo regimen) or twice monthly (simplified de Gramont regimen) for 24 weeks. Further randomization determined whether patients received the probiotic Lactobacillus rhamnosus GG gelatin capsules twice daily and daily fiber on cycle days 7–14 for 8 days per month during the 24 weeks of chemotherapy. All patients received dietary counseling and kept nutrition diaries. Treatment-related adverse effects were assessed at every cycle.

Sample Characteristics

  • The study reported on 148 patients.
  • Median age was 60 years, with a range of 31–75.
  • The sample was 49% female and 51% male.
  • Patients were scheduled to receive adjuvant chemotherapy after surgery for Dukes’ B or C CRC or chemotherapy following surgery for Dukes’ D CRC who were rendered free from metastases by the surgery.

Setting

The study was conducted at a single-site, outpatient setting in Finland.

Phase of Care and Clinical Applications

All patients were undergoing the active treatment phase of care.

Study Design

This was a prospective, randomized trial.

Measurement Instruments/Methods

The National Cancer Institute of Canada Common Toxicity Criteria, version 2, was used.

Results

  • Less grade 3-4 diarrhea occurred in patients receiving Lactobacillus supplementation than in those not receiving it (22% versus 37%; p = 0.027). 
  • Less abdominal discomfort (flatulence, borborygmi, or abdominal distention) of any grade occurred in patients receiving Lactobacillus than in those not receiving it (59% versus 75%; p = 0.058). 
  • Only 21% of the patients receiving Lactobacillus had chemotherapy dose reductions due to bowel toxicity as compared to 47% of those who did not receive this supplement (p = 0.0008). 
  • Lactobacillus supplementation had no significant effects on overall treatment toxicity or on the frequency of stomatitis or neutropenia.
  • Fiber supplementation did not affect overall gastrointestinal (GI) toxicity (p = 0.13).

Conclusions

The frequency of grade 3 or 4 diarrhea and the frequency of abdominal discomfort may be decreased with the use of Lactobacillus rhamnosus supplementation for patients receiving 5-FU-based chemotherapy.

Limitations

  • Adjuvant chemotherapy for CRC now commonly includes irinotecan, capecitabine, or oxaliplatin.  5-FU was the only adjuvant chemotherapy given in this study.
  • The study was neither placebo-controlled nor blinded to the administration of the fiber or Lactobacillus.
  • Metoclopramide and 5-HT3 inhibitors were used to treat nausea and vomiting. These medications could possibly have effected reported bowel toxicity.
  • No mention was made regarding whether patients were instructed to avoid yogurts and other dairy products produced by fermentation.
  • Use of antimicrobials was not mentioned as an exclusion criterion.

Nursing Implications

The administration of Lactobacilus rhamnosus GG may decrease the frequency and severity of diarrhea and abdominal discomfort with 5-FU-based chemotherapy. Further placebo-controlled, blinded studies are needed.

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