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.

Condition	Treatment or Intervention	Phase
Breast Cancer nausea and vomiting	Procedure: acupressure therapy  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: complications of therapy assessment/management  Procedure: manipulative and body-based interventions  Procedure: nausea and vomiting therapy  Procedure: supportive care/therapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Florida
      H. Lee Moffitt Cancer Center CCOP Research Base, Tampa,  Florida,  33612,  United States
Texas
      University of Texas M.D. Anderson CCOP Research Base, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Suzanne L. Dibble, DNSc, RN,  Principal Investigator,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000257016; MDA-NUR01-396; NCI-0109; NCI-P02-0230; NCT00046865
Record last reviewed:  January 2005
Last Updated:  January 6, 2005
Record first received:  October 3, 2002
ClinicalTrials.gov Identifier:  NCT00046865
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08