Breast Cancer Clinical Trial

Alternative Approaches for Nausea Control

Summary

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

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Full Description

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.

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Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

242

Study ID:

NCT01695993

Recruitment Status:

Completed

Sponsor:

University of Rochester

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There are 4 Locations for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Hematology-Oncology Associates of Central New York
East Syracuse New York, 13057, United States
Rochester General Hospital's Lipson Cancer and Blood Center
Rochester New York, 14621, United States
University of Rochester James P. Wilmot Cancer Center
Rochester New York, 14642, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

242

Study ID:

NCT01695993

Recruitment Status:

Completed

Sponsor:


University of Rochester

How clear is this clinincal trial information?

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