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Relaxation Program for Breast Cancer

Phase 3

Waitlist Available

Led By Lorenzo Cohen, PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older (patient and spouse/partner)

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

Must not have

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

Patients who have not undergone any surgical treatment for their cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to and during radiotherapy, through 6 week relaxation program and 12 months post radiotherapy

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing two relaxation techniques to see if they can improve physical and emotional wellbeing for breast cancer patients receiving radiation. Up to 700 people will take part.

Who is the study for?

This trial is for women aged 18 or older with stage 0 - III breast cancer, who are about to start daily radiation therapy for 4-6 weeks. Participants must be able to communicate in English or Spanish. It's not open to those who've practiced yoga recently, have significant mobility issues, major psychiatric conditions like schizophrenia or bipolar disorder, or haven't had surgery for their cancer.

What is being tested?

The study is testing two different relaxation programs involving stretching and relaxation techniques against a control group with no such program. The aim is to see if these programs improve the physical and emotional well-being of women undergoing radiation therapy for breast cancer.

What are the potential side effects?

Since this trial involves non-invasive activities like stretching and relaxation exercises, side effects may be minimal but could include muscle soreness or emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I and my spouse/partner are both 18 years old or older.

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I am a woman with early to locally advanced breast cancer scheduled for daily radiation therapy for 4-6 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot move in and out of a chair without help.

Select...

I have not had surgery for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to and during radiotherapy, through 6 week relaxation program and 12 months post radiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to and during radiotherapy, through 6 week relaxation program and 12 months post radiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to and during radiotherapy, through 6 week relaxation program and 12 months post radiotherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of Relaxation Program

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Waitlist Control Group (WLC)Experimental Treatment2 Interventions

Participants in this group given the option to take part in one of the two forms of relaxation (off study) after they finish their last questionnaire packet. 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.

Group II: Relaxation Group 2Experimental Treatment3 Interventions

Simple stretching exercises, specific breathing skills, and guided relaxation for 3 sessions, 3 times a week for 6 weeks. Each session should last about 60 minutes. Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study. 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.

Group III: Relaxation Group 1Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Questionnaires

2013

Completed Phase 2

~4280

0 / 4Eligibility criteria met