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

November 12, 2018 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupressure
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.
Procedure: management of therapy complications
Procedure: acupressure therapy
Procedure: nausea and vomiting therapy
Placebo Comparator: Placebo Acupressure
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.
Procedure: management of therapy complications
Procedure: acupressure therapy
Procedure: nausea and vomiting therapy
Sham Comparator: Usual Care
Arm III: Patients receive usual nausea care during the second or third course of chemotherapy.
Procedure: management of therapy complications
Procedure: nausea and vomiting therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Suzanne L. Dibble, DNSc, RN, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2002

Primary Completion (Actual)

March 23, 2006

Study Completion (Actual)

March 23, 2006

Study Registration Dates

First Submitted

October 3, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000257016
  • MDA-NUR01-396
  • NCI-0109
  • NCI-P02-0230
  • NCI-5950
  • NUR01-396 (Other Identifier: UT MD Andrerson Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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