Yoga or Stretching and Relaxation in Improving Physical Function in Patients with Stage 0-III Breast Cancer Undergoing Radiation Therapy

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIISupportive care18 and over2009-0976
NCI-2012-01895, NCT01202851

Trial Description

Summary

This randomized phase III trial studies yoga or stretching and relaxation in improving physical function in patients with stage 0-III breast cancer undergoing radiation therapy. Yoga therapy may help improve quality of life in breast cancer patients undergoing radiotherapy. It is not yet known if yoga is more effective than stretching and relaxation in improving physical function.

Further Study Information

PRIMARY OBJECTIVES:

I. Examine the efficacy of a yoga program incorporated into the treatment schedule for women with breast cancer undergoing radiotherapy.

II. Determine the effects of the yoga program on other aspects of adjustment.

III. Identify some of the processes underlying the efficacy of the intervention.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients attend 60-minute yoga classes 3 times per week for 6 weeks or 4-5 times per week for 4 weeks, concurrently with radiation therapy. Patients are then further randomized to maintenance comprising telephone contact once per month with booster sessions every 3 months after completion of therapy, or usual care, with no contact after completion of therapy.

ARM II: Patients attend 60-minute stretching and relaxation classes 3 times per week for 6 weeks or 4-5 times per week for 4 weeks, concurrently with radiation therapy. Patients are then further randomized to maintenance or usual care as in Arm I.

ARM III: Patients complete quality of life assessments.

After completion of study treatment, patients in the maintenance arms are followed up monthly, and patients in usual contact arms and in arm III are followed up at 3, 6, and 12 months.

Eligibility Criteria

Inclusion Criteria:

Able to read, write, and speak English or Spanish (patient and spouse/partner)

Women with stage 0-III breast cancer who will be undergoing daily adjuvant radiation for 4-6 weeks (patients only)

Exclusion Criteria:

Patients who have practiced yoga or taken yoga classes in the year prior to study enrollment or who are currently engaged in a regular mind-body practice

Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted)

Patients who have any major psychiatric diagnoses (e.g., schizophrenia, bipolar disorder)

Patients who have not undergone any surgical treatment for their cancer

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

M D Anderson Cancer Center

  • National Cancer Institute
Lorenzo Cohen, Principal Investigator

Trial Sites

U.S.A.

Texas
Houston

M D Anderson Cancer Center

Lorenzo Cohen
Ph: 713-745-4260
Email: lcohen@mdanderson.org

Lorenzo Cohen
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01202851

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.