Researchers sought to show that  some SSRI antidepressants reduce tamoxifen’s effectiveness by inhibiting its bioactivation by cytochrome P450 2D6 (CYP2D6).

The study enrolled postmenopausal women with breast cancer using tamoxifen therapy and a single SSRI antidepressant (paroxetine fluoxetine, sertraline, citalopram, fluvoxamine, or venlafaxine.)

The study included women living in Ontariowho were 66 years or olderand treated with tamoxifen for breast cancer between 1993 and 2005 and with a single SSRI. (24,430 women were identified; 2,430 entered into study; mean age was 74 years).

Inclusion criteria: Postmenopausal women with breast cancer newly treated with tamoxifen (defined as no tamoxifen prescription in the preceding year) and a single SSRI antidepressant (paroxetine fluoxetine, sertraline, citalopram, fluvoxamine, or venlafaxine)

Exclusion criteria: Antidepressant use of duloxetine or escitalopram

Ontario Cancer Registry provided the data.

This was a retrospective cohort study.

The study examines the total duration of tamoxifen therapy (index date: date tamoxifen was last dispensed plus an additional 60 days) and the extent to which co-prescription of potentially interacting medications occurred during the course of treatment. The primary outcome was death from breast cancer

Of 2,430 women treated with tamoxifen and single SSRI, 374 (15%) died of breast cancer during follow up. Absolute increases of 25%, 50%, and 75% in the proportion of time on tamoxifen overlappingthe  use of paroxetine were associated with 24%, 54%, & 91% increases in the risk of death from breast cancer. (p < 0.05) No such risk was seen with other antidepressants

Reported study limitations included lack of information on breast cancer stage and lack of information on indication for antidepressant use.

This intervention was therapeutic touch (TT). The experimental group received 10 minutes of TT and 20 minutes of dialogue, and the control group received 10 minutes of quiet time and 20 minutes of dialogue. Data were collected as part of a larger experimental study of the effects of TT on pre- and postoperative anxiety and mood and pain in women with breast cancer. Telephone interviews were conducted at the completion of an experimental or control nursing intervention administered in the women’s homes before and after breast cancer surgery. The interview consisted of six open-ended questions.

The study reported on a sample of 18 women with early-stage breast cancer.

Mixed methods of qualitative and quantitative study were used.

Telephone interviews consisting of six open-ended questions

Regardless of experimental or control intervention, women expressed feelings of calmness, relaxation, security, and comfort. No objective measures were reported.

• Validity and reliability of measures are unknown.
• The study had a very small sample size.

To evaluate irinotecan disposition and pharmacodynamics in the presence and absence of the broad-spectrum antibiotic neomycin

Patients experiencing grade 2 or higher diarrhea after receiving irinotecan alone (350 mg/m² every 3 weeks) received the same dose combined with 1,000 mg oral neomycin three times per day continuously from 2 days prior to 5 days after the second course.

The study reported on 20 patients with advanced colorectal cancer receiving CPT-11 (350 mg/m² every 3 weeks).

This was a nonrandomized trial. Patients acted as their own controls.

Presence of more than 4 stools per day and duration (measured in days) of diarrhea were recorded.

• Nine patients developed grade 2 diarrhea in the first chemotherapy course and were then given neomycin as cotreatment in the second course of chemotherapy.
• No significant effect was found on hematological toxicity (p > 0.05), but diarrhea improved in six out of seven patients (p = 0.033).

Findings indicate that bacterial B-glucorinidase plays a crucial role in irinotecan-induced diarrhea without affecting enterocycling and systemic SN-38 levels.
 

This was an extremely small pilot study.

STUDY PURPOSE: To evaluate published evidence regarding the effects of music on cancer-related pain 

• FINAL NUMBER STUDIES INCLUDED =  5
• TOTAL PATIENTS INCLUDED IN REVIEW = 248
• SAMPLE RANGE ACROSS STUDIES: 9–126 patients

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

Out of the five studies included, two showed significant differences in self-reported pain scores associated with the music intervention. Most studies were done outside of the United States, and in most studies, patients were offered a limited variety of prerecorded music for listening.

This review showed mixed results regarding the effects of listening to music on pain among patients with cancer in various phases of care.

• There were few studies included.
• There was no evaluation of study quality.
• Three out of five studies were done prior to 2000.

This review did not add substantially to the body of evidence regarding the use of music for cancer-related pain. There are a number of more recent studies that have shown greater efficacy and are of higher quality than those reviewed here.

To determine the effects of treatments for nausea and vomiting either as a result of the disease or its treatment in adults with cancer and other chronic diseases

Databases reviewed searched were MEDLINE, Embase, and the Cochrane database. Harm alerts from the Food and Drug Administration (FDA) and the United Kingdom regulatory agency also were reviewed.

No separate description of the volume of literature evaluated or the specific evaluation process was provided. The Grading of Recommendations Assessment, Development and Evaluation (GRADES) system was used for rating the evidence, and these results were provided. The literature review was completed as of April 2008.

The study reported on 13 randomized, controlled trials (RCTs), representing more than 14,000 patients with cancer. These included studies of nausea and vomiting as a result of disease or treatment.

Results indicated that 5-HT₃ RAs + dexamethasone was beneficial.

The following were identified as likely to be beneficial.

• 5-HT₃ RAs + corticosteroid with radiotherapy-induced nausea and vomiting
• Aprepitant added to conventional regimens
• Haloperidol
• Metoclopramide for chemotherapy-induced nausea and vomiting (CINV)
• Phenothiazines
• Venting gastrostomies

Cannabinoids were identified as being a tradeoff between benefit and harm.

The following were determined to have unknown effectiveness.

• 5-HT₃ receptor antagonists (RAs) for radiation-induced nausea and vomiting
• Antihistamines
• Antimuscarinics
• Antipsychotics
• Benzodiazepines for CINV

• Although no evidence was identified, and, at this writing, there was a stated drug safety alert on haloperidol, this review identified haloperidol as likely to be beneficial. It is unclear how this can meet this category.
• Results cited tended to focus on vomiting episodes and did not address the symptom of nausea.
• Results were a mix of symptoms from the disease itself or treatment, so differentiation of applicability was not always clear.
• Some aspects of the search strategy were unclear.
• Some interventions stated that no RCTs or systematic reviews were found, so no evidence was provided; however, in other areas, observational studies and consensus opinions were cited as supporting evidence.
• Inclusion and exclusions were not stated.
• No information was included on nonpharmacologic interventions in combination with antiemetic regimens.

Intervention goals were to

1. Educate patient/partner dyads about cancer pain and management.
2. Teach dyads a variety of pain coping strategies.
3. Teach partners how to help patients acquire and maintain coping skills.

Three 45- to 60-minute face-to-face sessions with an RN educator for training in pain management strategies were delivered over one to two weeks. Educators were knowledgeable about cancer pain and skilled in coping skills training interventions. Four educators were used, and quality assurance plans were described.

• In session 1, the training program and materials were explained, a videotape was shown, and a book was given regarding barriers, treatments, side effects, and healthcare provider communication.
• In session 2, participants received relaxation training and guided imagery.
• In session 3, an activity pacing method was introduced.

For sessions 2 and 3, the educator guided participants through skills, partners were asked to serve as coach, and the educator provided feedback.

Following completion of the three sessions, the educator reviewed the coping skills found most useful and developed a maintenance plan.

• The sample (N = 78) was comprised of patient/partner dyads.
• Participants were assigned to the intervention group (n = 41) or a control group (n = 37) receiving standard care through their medical outpatient or hospice program.
• Patients had advanced cancer diagnoses and were experiencing disease-related pain (worst pain rating of > 3 on the Brief Pain Inventory), a life expectancy of less than six months, and no change in their disease treatment planned.
• Patients were older than 18 years of age and met Medicare hospice benefit eligibility criteria (regardless of enrollment).

Home setting

A properly randomized, controlled trial design was used (with small sample size). Power analysis was not reported.

• Caregiver Strain Index
• Chronic Pain Self-Efficacy Scale (for caregivers)
• Profile of Mood States–Brief

A trend toward reporting lower levels of caregiver strain (p = 0.06) existed.

Partners receiving the intervention reported significantly higher levels of self-efficacy for helping patients control pain and significantly higher levels of self-efficacy for helping patients control other symptoms.

No significant difference was found in positive or negative mood.

• The sample size was small.
• The study had high attrition rates (31.7% in the intervention group and 24.3% in the control group).

To determine whether the oral administration of calcium aluminosilicate clay (CASAD) reduces the rate of grade 3 diarrhea associated with irinotecan administration in patients with colorectal cancer

Patients were provided with CASAD or placebo capsules. The treatment arm received capsules containing 500 mg of the active compound taken as two tablets four times daily. Treatment lasted for six weeks or until treatment criteria were met. After six weeks, all patients were offered off-label CASAD for an additional six weeks. Patients who developed diarrhea were provided standard-of-care antidiarrheal medication. Patients completed baseline assessments of bowel statuses and additional assessments at three, five, and six weeks. Daily bowel logs were completed by patients and reviewed at the third, fifth, and sixth provider visits.

• N = 100
• AGE RANGE = 20–83 years
• MALES: 54%, FEMALES: 46%
• KEY DISEASE CHARACTERISTICS: Metastatic colorectal cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Scheduled to receive irinotecan alone or with other agents: Eastern Cooperative Oncology Group status ≤ 2

• SITE: Multi-site
• SETTING TYPE: Outpatient
• LOCATION: MD Anderson and affiliates

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

This was a phase II, randomized, double-blinded, multicenter study. Patients were randomized on a 1:1 ratio to receive CASAD or a placebo. Patients were stratified according to irinotecan therapy, no concurrent therapy, or concurrent therapy in addition to irinotecan.

• MD Anderson Symptom Inventory (MDASI)
• Patient completed bowel/ostomy assessment
• Daily diary

There were no differences between groups. In the CASAD arm, seven out of 49 patients in the CASAD arm versus three out of 46 patients in the placebo arm developed grade 3 diarrhea during the first six weeks (PR = 0.10). The incidence of any grade of diarrhea was similar in both arms. There was no difference in gastrointestinal (GI) toxicities between the two groups.

CASAD was ineffective in preventing diarrhea in this patient population. There were no issues with GI toxicities, indicating that CASAD was clinically safe.

• Subject withdrawals ≥ 10%
• Other limitations/explanation: Weak science on which study it was based on

CASAD is not indicated as a preventive measure for diarrhea associated with irinotecan administration.

To systematically review the currently available high-quality evidence evaluating treatments for moist desquamation in patients receiving radiotherapy

Databases used were AMED, BIOMED, BIOSIS, BNI, British Library Integrated Catalogue, CINAHL, Cochrane, Current Controlled Trials, DARE, Dissertation Abstracts, DoH Research Findings Register, EMBASE, HSRProj, IBSS, Index to Theses, ISI Wok, Medline, National Cancer Research Network, National Register of Cancer Trials, National Research Register, PROQUEST, and ZETOC. Keywords searched were radiotherapy, radiation therapy, deep x-ray therapy, irradiation, wounds, moist desquamation, desquamation burns, radiation burns, radiotherapy burns, broken skin, ulcers, wound healing, skin care, wound care, and epithelial. Studies were included if they

• Were randomized controlled trials or controlled clinical trials
• Investigated the impact of one or more interventions for moist desquamation in patients of any diagnosis receiving radiation therapy
• Included measurements of wound healing time or other skin integrity measures and some form of patient comfort or acceptability measure.

Studies were excluded if they

• Were not in a language where translation was available to the author
• Were published before 1990
• Did not have a control
• Investigated prophylactic agents or preventive interventions only.

The search returned 166 articles. Of these, 20 were relevant. Only 10 were included in the review. Studies were evaluated for quality using the CASP guidelines for clinical trials. Of the 10 studies that met inclusion criteria, none were judged to be of very poor quality, so all were included in the review. Studies were not homogenous in interventions or variables examined, so no meta-analysis was undertaken. A qualitative overview of results is presented.

• The total sample size across 10 studies was approximately 575.
• Some studies did not specify the number of patients in a control group.
• Most studies did not find a significant difference associated with interventions; two studies showed a statistically significant reduction in healing time in their intervention group (studies using gentian violet), and one study showed a significantly increased healing time in their intervention group (hydrogel).
• All studies examined the use of some type of topical skin treatment.

• Hydrogel and hydrocolloid dressings have been recommended by professional groups and are founded on moist wound healing principles; however, this review found conflicting evidence to support the use of either of these. It was noted that these can be very expensive and can leak.
• Limited evidence supports the effectiveness of other types of dressing.
• Limited evidence supports creams and other topical agents.
• Gentian violet was the most frequently used control substance. It was noted that this is no longer recommended by the department of health in the UK because of its carcinogenic potential.

No convincing evidence for any intervention was found. Evidence was mixed concerning the use of hydrogel and hydrocolloid dressings; however, improved patient comfort was sometimes seen with these. Other dressings studied did not show positive results and comparison dry dressings may cause injury of granulating tissue with daily removal for treatment. A number of other types of dressings that might be useful were briefly identified, but there are no reports of research using these yet. Limited evidence supports other interventions. Most findings with topical agents were equivocal. In one study, hydrocortisone cream appeared to reduce healing time (abstract only).

Although the author states that the 10 studies included were all of sufficient quality for use according to the guidelines used, results reported per study indicate that one study may have reported information that was untrue, one study was identified as being poorly reported with insufficient information, and one study was identified as fairly low quality.

Well-designed research in this area is urgently needed.

To examine differences in incidence and risk of chemotherapy-induced nausea and vomiting (CINV) among patients receiving low emetogenic chemotherapy (LEC) with or without prophylactic granisetron 

The first cohort of patients received 8 mg IV bolus dexamethasone or 10 mg metachloepramide. The second cohort also was given 3 mg IV bolus of granisetron.  Both groups were given dexamethasone (2-4 mg twice daily) or metochlopramide (10 mg three times daily) tablets to be taken for three days after chemotherapy. CINV was evaluated for 120 hours, days 1–5 after chemotherapy.

• The study consisted of 94 patients.
• Mean age of patients was 53.4 years.
• The sample was 51% male and 48% female.
• Disease types were not described.
• Drugs used in chemotherapy were gemcitabine, vinorelbine, fluorouracil, and docetaxel.
• The percentage of patients who were chemotherapy naïve was 19% in both groups.

The study was conducted at a single outpatient site in Malaysia.

All patients were in active, antitumor treatment.

This was a two-group cohort, observational trial.

• Patients recorded emesis in diaries using a rating system adapted from the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool.
• Complete control was defined as no nausea or vomiting and no use of rescue medication.

Those who received granisetron had lower rates of acute and delayed nausea and emesis. The only significant difference between groups was in the prevalence of acute emesis; 3.9% of those who received granisetron experienced acute emesis versus 19% of those who did not receive granisetron (p = 0.017). No differences were found between groups in complete control rates in either the acute or delayed phases. With analysis controlling for covariates influencing CINV, those receiving granisetron had a lower risk of CINV (overall response [OR] = 0.1, 95% confidence interval [CI] = 0.02–0.85, p = 0.034).

Patients receiving granisetron in addition to antiemtic regimens recommended for LEC had a lower incidence of acute emesis, but no effect was found on delayed phase symptoms or acute nausea.

• The sample size was small with fewer than 100 patients.
• A risk of bias exists because no blinding or random assignment was used.

Common recommendations for CINV prophylaxis with LEC do not include the use of neurokinin 1 (NK1) or 5-HT₃ medications but, rather, rely primarily on the use of increased dexamethasone dosage for control. This study examined the addition of a 5-HT₃ to an LEC antiemetic regimen and demonstrated a significant improvement in acute emesis. Granisetron is more costly than a single-agent antiemetic regimen such as dexamethasone, so additional antiemetic use is seen as controversial or “overtreatment.” Nurses can advocate for consideration of aggressive prevention of CINV to minimize the adverse patient experience with chemotherapy, balanced with recognition of potential cost burdens to the patient. As shown in many other studies, control of nausea (rather than emesis) remains challenging. The strength of findings in this study are limited by the study design. Further well-designed research in this area is warranted.

To evaluate the impact of a nursing intervention incorporating structured symptom assessment and management of the chemotherapy-related symptoms of nausea, vomiting, fatigue, and mucositis.

A consecutive sample of 249 patients, who were scheduled to receive first-line chemotherapy, received structured symptom assessment and management, facilitated by WISECARE+, an information technology–based program. Symptom data was self-report by patients using a paper questionnaire for 14 consecutive days following each cycle of chemotherapy, starting on the first day of treatment.

• In total, 249 patients (22.9% male, 77.1% female) were included.
• Age was 15 to 85+ years.
• Patients had breast, lung, ovarian, or colorectal cancer; osteosarcoma; acute myeloid leukemia (AML); acute lymphoblastic leukemia (ALL); or lymphoma.
• Patients were chemotherapy-naïve, physically and psychologically fit adults.

• Multisite
• Inpatient and outpatient
• Pan-European:  eight clinical sites in Belgium, Denmark, England, Ireland, and Scotland

Patients were undergoing the active treatment phase of care.

The study used a pre- and postintervention design.

• The Chemotherapy Symptom Assessment Scale (C-SAS) rigorously tested for criterion validity, construct validity, test-retest reliability, and internal consistency (a = 0.75).   
• WISE Tool (electronic patient and symptom record/database):  No validity or reliability data were provided.

Patients experienced less nausea postintervention, but pre/post differences were only significant at days 0 to 4 (p = 0.025). Similarly, patients had less vomiting after the intervention but pre and post differences were only significant at days 0 to 4 (p < 0.001). Although changes in oral problems varied at different time points in the study, overall repeated measures analysis showed reduction in oral problems over the course of the study (p = 0.016). There was no effect of the intervention on fatigue.

Structured nursing symptom assessment and management of chemotherapy-related symptoms improved the symptoms of nausea, vomiting, and oral problems (mucositis) related to chemotherapy.

• No appropriate control group was used.
• The study sample was extremely heterogeneous, and the study was possibly underpowered.
• The study did not evaluate interventions specific to mucositis but, rather, the format or structuring of interventions. The study was not designed to specify if the oral problems were strictly mucositis.

The study used patient-assessed symptom data that was collected in real time. The data measured the incidence, severity, and associated distress of the symptoms. Additional research is needed to evaluate the effectiveness of the structured symptom assessment and management of chemotherapy-related symptoms.