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Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
This study has been completed.
Study NCT00046865   Information provided by National Cancer Institute (NCI)
First Received: October 3, 2002   Last Updated: February 6, 2009   History of Changes

October 3, 2002
February 6, 2009
October 2002
 
 
 
Complete list of historical versions of study NCT00046865 on ClinicalTrials.gov Archive Site
 
 
 
Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
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.

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.

Phase III
Interventional
Supportive Care, Randomized, Active Control
  • Breast Cancer
  • Nausea and Vomiting
  • Procedure: acupressure therapy
  • Procedure: management of therapy complications
  • Procedure: nausea and vomiting therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00046865
 
CDR0000257016, MDA-NUR01-396, NCI-0109, NCI-P02-0230, NCI-5950
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Suzanne L. Dibble, DNSc, RN, PhD UCSF Helen Diller Family Comprehensive Cancer Center
National Cancer Institute (NCI)
November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP