Alternative Approaches for Nausea Control

Study Overview
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Brief Summary
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216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who expect to have nausea, will be entered. Participants will be randomized to one of three study arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands. Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea

Detailed Description
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Earlier research has shown that the effectiveness of acupressure bands in reducing nausea could be enhanced by boosting patients' expectations of the bands' efficacy. The present study seeks to confirm and extend these findings in a multi-site, 3-arm, randomized, controlled study of 216 breast cancer patients beginning chemotherapy who expect to have nausea. All patients will receive a standardized antiemetic regimen. Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands. The investigators hypothesize that acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea. The two versions of the handout and MP3 are being examined to determine what is the most effective way to deliver the intervention.

Official Title
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Alternative Approaches for Nausea Control

Conditions
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Nausea

Intervention / Treatment
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* Device: Acupressure bands
* Other: Expectancy-neutral handout
* Behavioral: Expectancy-neutral MP3
* Other: Expectancy-enhancing handout
* Behavioral: Expectancy-enhancing MP3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be female. Have a diagnosis of breast cancer, any stage. Be chemotherapy naïve and about to begin her first course of chemotherapy. Be scheduled to receive one of the following four common chemotherapy regimens with the specified antiemetic regimen. They are: Chemotherapy regimen: Doxorubicin/cyclophosphamide. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3. Chemotherapy regimen: Doxorubicin/cyclophosphamide/docetaxel. Antiemetic regimen: Aprepitant + palonosetron + dexamethasone on Day 1 and aprepitant + dexamethasone on Days 2 & 3. Chemotherapy regimen: Docetaxel/carboplatin. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3. Chemotherapy regimen: Docetaxel/cyclophosphamide. Antiemetic regimen: Palonosetron on Day 1 + dexamethasone on Days 1, 2, & 3. Note: Fosaprepitant will be allowed in place of aprepitant, and either granisetron or ondansetron, on one or more days, will be allowed in place of palonosetron. Have a response of > 3 or greater on a question assessing expected nausea as assessed on a 5-point Likert-scale anchored at one end by 1 = I am certain I WILL NOT have this, and at the other end by 5 = I am certain I WILL have this. Be able to read English (since the assessment materials are in printed format). Be 18 years of age or older and give written informed consent. Exclusion Criteria: Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist. Be receiving concurrent radiotherapy or interferon.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1 - Standard Care Only<br>Patients will receive standard care only | |
| Other: Arm 2 - Expectancy-neutral Arm<br>Patients receive: Expectancy-neutral handout Expectancy-neutral MP3 Acupressure bands | Device: Acupressure bands<br>* Bilateral acupressure wrist bands<br>Other: Expectancy-neutral handout<br>* The expectancy neutral handout has neutral information regarding the acupressure bands<br>Behavioral: Expectancy-neutral MP3<br>* Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery.<br>|
| Experimental: Arm 3 - Expectancy-enhancing Arm<br>Patients receive: Expectancy-enhancing handout Expectancy-enhancing MP3 Acupressure bands | Device: Acupressure bands<br>* Bilateral acupressure wrist bands<br>Other: Expectancy-enhancing handout<br>* The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands<br>Behavioral: Expectancy-enhancing MP3<br>* Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. It also has expectancy-enhancing information regarding the acupressure bands.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Report Nausea Diary | Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = Not at all nauseated and at the other end by 7 = Extremely nauseated. The outcome variable for the primary analysis was greatest reported nausea from the five day period. | five days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nausea, Quality of life, Chemotherapy, Expectancy