Relaxation Program for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Major psychiatric diagnoses, No surgery, Extreme mobility issues, Yoga practice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how two different relaxation programs can enhance the physical and emotional well-being of breast cancer patients undergoing radiation therapy. Participants will either engage in simple stretching, breathing exercises, and guided relaxation or join a comparison group that does not participate in these activities. Women with stage 0-III breast cancer scheduled to begin daily radiation therapy for 4-6 weeks may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on relaxation programs, so it's likely you can continue your medications, but please confirm with the study team.

What prior data suggests that these relaxation programs are safe for breast cancer patients receiving radiation therapy?

Research has shown that relaxation training can benefit people with breast cancer. One study found that relaxation techniques during chemotherapy reduced anxiety and other uncomfortable feelings. Another study discovered that cancer patients often use relaxation exercises, such as deep breathing and progressive muscle relaxation, to reduce pain and improve overall well-being.

Research supports the safety of relaxation programs. Health experts often recommend these generally safe exercises to manage stress and enhance the quality of life for cancer patients. Reports of negative effects from these techniques are rare, making them a well-tolerated option for boosting emotional and physical health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of a structured relaxation program on breast cancer patients undergoing radiation therapy. Unlike standard treatments that typically focus on chemotherapy, radiation, and surgery, this program emphasizes simple stretching exercises, specific breathing skills, and guided relaxation. These methods aim to help manage stress and reduce cortisol levels, which is something traditional treatments don’t address directly. By collecting saliva samples to monitor cortisol, the trial seeks to uncover whether relaxation techniques can improve the overall well-being and potentially enhance the treatment outcomes for breast cancer patients.

What evidence suggests that these relaxation programs could be effective for breast cancer patients?

Studies have shown that relaxation programs can greatly benefit breast cancer patients. For instance, exercises such as progressive muscle relaxation significantly reduce pain and enhance quality of life. Research also indicates that these exercises lower depression and anxiety levels in breast cancer patients. This trial will evaluate two different relaxation programs, each incorporating simple stretching exercises, specific breathing skills, and guided relaxation. These techniques can be particularly beneficial for those undergoing stressful treatments like radiation therapy. Overall, relaxation techniques have proven effective in easing the emotional and physical stress often associated with battling breast cancer. ^{4 6 7 8 9}

Who Is on the Research Team?

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

You have practiced yoga or similar mind-body activities in the past year or are currently doing so.

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

You have been diagnosed with serious mental illnesses like schizophrenia or bipolar disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Radiation Therapy

Participants undergo radiation therapy while participating in relaxation programs or control group activities

4-6 weeks

3-5 sessions per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including questionnaires and saliva testing

12 months

Questionnaires and saliva samples at 3, 6, and 12 months post-radiotherapy

Maintenance Intervention

Participants in the maintenance intervention arm receive telephone counseling and booster sessions post-radiotherapy

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Relaxation Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Waitlist Control Group (WLC) Experimental Treatment 2 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 2 Experimental Treatment 3 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 1 Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38635763/

Progressive relaxation training in patients with breast ... The study demonstrated that Progressive Relaxation Exercises caused a significant reduction in pain scores among Breast Cancer patients receiving Aromatase ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0301020

Progressive relaxation training in patients with breast cancer ... The study demonstrated that Progressive Relaxation Exercises caused a significant reduction in pain scores among Breast Cancer patients receiving Aromatase ...

3. tcr.amegroups.org tcr.amegroups.org/article/view/62580/html

A systematic review and meta-analysis of the effects of muscle ... The results showed that muscle relaxation training can significantly reduce depression and anxiety in breast cancer patients, improve their quality of life.

4. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-024-02459-w

A survey of cancer patients' interest in undertaking exercise to ... Ample evidence shows that relaxation therapy interventions are effective in reducing stress and anxiety that are frequently associated with RT.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S174438812200144X

Effects of progressive muscle relaxation on health-related ... This systematic review and meta-analysis indicated that PMRT was effective to relieve symptoms of anxiety and pain experienced by cancer patients and improve ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3832338/

Relaxation training during chemotherapy for breast cancer ... Conclusion: Relaxation training during chemotherapy can reduce anxiety and other adverse events in postoperative breast cancer patients. This should be ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04826367?term=AREA%5BConditionSearch%5D(Covid-19%20AND%20%22Skin%20Diseases%22)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=8

Relaxation Training by Tele-Rehabilitation in Patients With ... The purpose of our study; to examine the effects of relaxation exercises performed by tele-rehabilitation on functional capacity, fatigue, emotional state, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11143565/

A survey of cancer patients' interest in undertaking exercise to ... Among the various relaxation exercises, breathing exercises had the greatest appeal (39.7%), followed by progressive muscle relaxation (32.4%) ...

9. nevadacancercoalition.org nevadacancercoalition.org/blog/relaxation-can-lead-better-cancer-outcomes

Relaxation can lead to better cancer outcomes Health experts at the National Cancer Institute suggest a number of ways to relieve stress, including relaxation and imagery exercises, akin to ...