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


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Drug-induced Nausea and Vomiting

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

Suzanne L. Dibble, DNSc, RN, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Institutional Review Board

Study ID:

CDR0000257016

NCT ID:

NCT00046865

Start Date:

October 2002

Completion Date:

March 2006

Related Keywords:

  • Breast Cancer
  • Drug-induced Nausea and Vomiting
  • 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
  • Breast Neoplasms
  • Nausea
  • Vomiting

Name

Location

University of Texas M.D. Anderson CCOP Research BaseHouston, Texas  77030-4009
H. Lee Moffitt Cancer Center CCOP Research BaseTampa, Florida  33612