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

This study has been completed.
Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
Official Title † Treatment of Chemotherapy-Induced Nausea With Acupressure: A Phase III Trial
Brief 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.
Detailed 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 Phase Phase III
Study Type † Interventional
Study Design † Supportive Care, Randomized, Active Control
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Breast Cancer
Nausea and Vomiting
Intervention † Procedure: acupressure therapy
Procedure: management of therapy complications
Procedure: nausea and vomiting therapy
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Completed
Enrollment †
Start Date † October 2002
Completion Date
Eligibility 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
Gender Female
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00046865
Organization ID CDR0000257016
Secondary IDs †† MDA-NUR01-396, NCI-0109, NCI-P02-0230, NCI-5950
Study Sponsor † M.D. Anderson Cancer Center
Collaborators †† National Cancer Institute (NCI)
Investigators †
Principal Investigator:     Suzanne L. Dibble, DNSc, RN, PhD     UCSF Helen Diller Family Comprehensive Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date November 2004
First Received Date † October 3, 2002
Last Updated Date January 12, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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