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

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Drug-induced Nausea and Vomiting

Treatments: Procedure: management of therapy complications; Procedure: nausea and vomiting therapy; Procedure: acupressure therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00046865

CDR0000257016

NCI-P02-0230

MDA-NUR01-396

NCI-5950

NUR01-396 (Other Identifier)

NCI-0109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 3 patient groups, including a placebo group

Acupressure

Experimental group

Description:

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.

Treatment:

Procedure: management of therapy complications

Procedure: nausea and vomiting therapy

Procedure: acupressure therapy

Placebo Acupressure

Placebo Comparator group

Description:

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.

Treatment:

Procedure: management of therapy complications

Procedure: nausea and vomiting therapy

Procedure: acupressure therapy

Usual Care

Sham Comparator group

Description:

Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.

Treatment:

Procedure: management of therapy complications

Procedure: nausea and vomiting therapy