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Relaxation for Women With Breast Cancer Undergoing Radiotherapy

NCT01202851 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 681

Last updated 2026-05-05

No results posted yet for this study

Summary

The goal of this behavioral research study is to compare two different forms of relaxation programs that will include stretching and relaxation techniques, in order to learn if and how well they may help to improve physical and emotional well-being. This will be tested in patients with breast cancer who are receiving radiation therapy. For comparison purposes, there will also be a group of participants that does not take part in the relaxation programs.

This is an investigational study. The relaxation programs are being compared for research purposes only.

An "assessment" is any time you complete a set of scheduled activities for this study, such as tests and questionnaires.

Up to 700 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions

Interventions

OTHER

Saliva Testing

4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.

OTHER

Relaxation Program

3 times a week, 60 minute sessions for 6 weeks.

BEHAVIORAL

Questionnaires

Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Lorenzo Cohen, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-10
Primary Completion
2028-02-28
Completion
2028-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01202851 on ClinicalTrials.gov