Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00046865
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Completed
Phase	Phase 3
Start date	July 1, 2002
Completion date	March 23, 2006

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms