Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2018 |
| Start Date: | July 1, 2002 |
| End Date: | March 23, 2006 |
Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial
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.
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.
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.
- 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.
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
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