Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Acupressure may help to reduce or prevent nausea in patients who are undergoing chemotherapy. It is not yet known whether acupressure plus standard care for nausea is more effective than standard care alone for nausea in women who are receiving chemotherapy for breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of acupressure in treating nausea in women who are receiving combination chemotherapy for breast cancer.

Detailed Description
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OBJECTIVES: Compare nausea experience and intensity in women with breast cancer receiving one of three combination therapy regimens when treated with standard nausea care plus acupressure vs standard nausea care alone. Compare the quality of life, presence of anxiety, and functional status of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to chemotherapy regimen (doxorubicin and cyclophosphamide vs doxorubicin, cyclophosphamide, and fluorouracil vs doxorubicin with paclitaxel or docetaxel vs fluorouracil, epirubicin, and cyclophosphamide) and treatment setting. Patients are randomized to 1 of 3 arms. Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes. Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site. Arm III: Patients receive usual nausea care during the second or third course of chemotherapy. All patients complete a daily log during the second or third course of chemotherapy. Quality of life is assessed at baseline and after the last treatment. PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 2 years.

Official Title
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Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial

Conditions
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Breast Cancer, Drug-induced Nausea and Vomiting

Intervention / Treatment
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* Procedure: acupressure therapy
* Procedure: management of therapy complications
* Procedure: nausea and vomiting therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of breast cancer and receiving one of the following combination therapy regimens: Doxorubicin and cyclophosphamide with or without fluorouracil Doxorubicin with paclitaxel or docetaxel Fluorouracil, epirubicin, and cyclophosphamide Must be beginning second or third course of chemotherapy Nausea intensity with prior chemotherapy of at least 3 (moderate) on the intensity scale of the Morrow Assessment of Nausea and Emesis Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age Adult Sex Female Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other Concurrent antiemetics allowed

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupressure<br>Arm I: Patients receive active acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied to a specific site each morning and again whenever nausea is experienced for 3-6 minutes. | Procedure: acupressure therapy<br> <br> Procedure: management of therapy complications<br> <br> Procedure: nausea and vomiting therapy<br> <br> |
| Placebo Comparator: Placebo Acupressure<br>Arm II: Patients receive placebo acupressure plus usual nausea care during the second or third course of chemotherapy. Acupressure is applied as in arm I except at a non-specific site. | Procedure: acupressure therapy<br> <br> Procedure: management of therapy complications<br> <br> Procedure: nausea and vomiting therapy<br> <br> |
| Sham Comparator: Usual Care<br>Arm III: Patients receive usual nausea care during the second or third course of chemotherapy. | Procedure: management of therapy complications<br> <br> Procedure: nausea and vomiting therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea and vomiting, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer