Couples-Based Yoga for Brain Cancer

Overseen By Kathrin Milbury, MA,PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Yoga practice, Life expectancy, Cognitive deficits

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a couples-based Hatha yoga program can improve the quality of life for individuals with high-grade glioma (a type of brain cancer) undergoing radiation therapy, along with their partners. The focus is on enhancing aspects such as fatigue, distress, sleep quality, and overall well-being. Participants will either join the yoga sessions or be in a waitlist control group, receiving standard care and completing questionnaires. This trial suits individuals diagnosed with glioma who are about to begin at least four weeks of radiation therapy and have a partner or caregiver willing to join the sessions. As an unphased trial, it offers a unique opportunity to explore complementary therapies that may enhance quality of life during treatment.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the couples-based yoga program is safe for patients with high-grade glioma and their partners?

Research has shown that yoga is generally safe for cancer patients. Studies indicate that yoga can reduce stress and enhance quality of life. For couples participating in a yoga program, it has proven to be safe and beneficial. One study found that a yoga program for couples was not only safe but also practical and helpful for patients with brain tumors and their caregivers. This suggests the yoga program is manageable and free from harmful side effects. Participants in those studies reported feeling less tired, experiencing reduced stress, sleeping better, and enjoying an improved overall quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Couples-Based Yoga Program for brain cancer because it offers a holistic approach that actively involves both patients and their partners in the healing process. Unlike standard treatments, which often focus solely on medical interventions like surgery, chemotherapy, and radiation, this program emphasizes mental and physical wellness through joint yoga sessions. Key features include breath synchronization, postures combined with deep relaxation, and meditation, all designed to enhance well-being and potentially improve quality of life during challenging cancer treatments. This approach not only aims to support the patient's physical health but also strengthens the emotional and mental well-being of both patients and their partners.

What evidence suggests that the couples-based yoga program is effective for improving quality of life in patients with high-grade glioma?

Research has shown that a couples-based Hatha yoga program, which participants in this trial may receive, might benefit patients with high-grade glioma and their partners. Studies have found that it can help reduce fatigue and distress, while improving sleep and overall quality of life. In one study, both patients and caregivers reported benefits from the program. Another study noted a meaningful reduction in cancer-related symptoms. These findings suggest that yoga could enhance life quality during radiation therapy. ^{1 2 3 4 6}

Who Is on the Research Team?

Kathrin Milbury, MA,PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking couples where one partner has a high-grade glioma brain tumor and will undergo radiation therapy. The patient must be fairly active (KPS of 80+) and have a caregiver willing to join the yoga program. Patients with short life expectancy, cognitive deficits, or recent regular yoga practice are excluded.

Inclusion Criteria

I can carry out normal activities with minimal symptoms.

I have a caregiver willing to join me in the study, or I can bring an alternate for yoga sessions.

I have a brain tumor and will undergo radiotherapy with 20 or more sessions.

Exclusion Criteria

For phase 1 only, regularly (self-defined) participated in a yoga practice in the year prior to diagnosis

For phase 1 and 2, cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team

My doctor thinks I have less than 6 months to live.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo radiation therapy while participating in a couple-based Hatha yoga program

5-6 weeks

5 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Couples-Based Yoga Program

Trial Overview The study tests if a Hatha yoga program can improve quality of life, reduce fatigue and distress, and enhance sleep for patients with high-grade glioma and their partners during radiation treatment.

How Is the Trial Designed?

Group I: Arm I (couple-based Hatha yoga program) Experimental Treatment 4 Interventions

Patients and their partners attend up to 15, 45-60 minute sessions of Hatha yoga over the course of radiation therapy 5 times a week for 5-6 weeks. The program comprises four main components: joint loosening with breath synchronization; postures with deep relaxation techniques; breath energization with sound resonance; and meditation. At the fifth session, patients and their partners receive a DVD and are encouraged to practice on their own (individually and/or together) on the days when they do not meet with the instructor.

Group II: Arm II (waitlist control) Active Control 3 Interventions

Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A one-on-one yoga therapy session delivered via telehealth significantly reduced physical and global distress in cancer patients, with notable improvements in anxiety and fatigue, based on data from 95 patient encounters.

The study highlights the potential of yoga therapy as an effective complementary treatment in oncology, suggesting that even a single session can lead to meaningful symptom relief, warranting further research on long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga Therapy in Cancer Care via Telehealth During the COVID-19 Pandemic. Mallaiah, S., Narayanan, S., Wagner, R., et al.[2022]

In a study of 68 breast cancer patients undergoing radiotherapy, an integrated yoga program significantly reduced anxiety and depression levels, as measured by the Hospital Anxiety and Depression Scale (HADS), while the control group experienced increased anxiety and depression.

Although both groups showed elevated radiation-induced DNA damage after treatment, the yoga group exhibited slightly less DNA damage compared to the control group, suggesting that yoga may help mitigate some of the negative effects of radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an integrated yoga program in modulating psychological stress and radiation-induced genotoxic stress in breast cancer patients undergoing radiotherapy. Banerjee, B., Vadiraj, HS., Ram, A., et al.[2022]

A nationwide phase III randomized controlled trial involving 410 cancer survivors found that a 4-week yoga therapy program (YOCAS) significantly improved cancer-related fatigue (CRF) compared to standard survivorship care.

Improvements in sleep quality and reductions in daytime dysfunction were found to mediate 22% to 37% of the positive effects of yoga on CRF, suggesting that enhancing sleep may be a key mechanism through which yoga therapy benefits cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Yoga on Cancer-Related Fatigue and on Mediational Relationships Between Changes in Sleep and Cancer-Related Fatigue: A Nationwide, Multicenter Randomized Controlled Trial of Yoga in Cancer Survivors. Lin, PJ., Kleckner, IR., Loh, KP., et al.[2020]

A review of 29 randomized controlled trials found that yoga significantly improves overall quality of life for cancer patients and survivors, particularly reducing fatigue and enhancing stress management during and after treatment.

Yoga may also positively influence biomarkers related to stress, inflammation, and immune function, although further research is needed to clarify its effects on anxiety, depression, and other specific cancer symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga for symptom management in oncology: A review of the evidence base and future directions for research. Danhauer, SC., Addington, EL., Cohen, L., et al.[2023]

Therapeutic yoga has been shown to improve various aspects of quality of life for cancer patients, including better sleep, reduced anxiety and depression, and enhanced spiritual well-being, based on a review of multiple studies.

The absence of side effects and the positive feedback from participants suggest that yoga could be a beneficial complementary therapy for cancer patients, although the studies had methodological limitations that warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of yoga on patients with cancer: our current understanding. Côté, A., Daneault, S.[2022]

Regular Iyengar yoga practice for 90 minutes twice a week over 8 weeks significantly reduced morning and evening salivary cortisol levels in breast cancer survivors, indicating improved stress regulation.

Participants in the yoga group reported better emotional well-being and lower fatigue, suggesting that yoga may enhance psychosocial functioning and could be a beneficial, low-risk intervention for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Iyengar yoga practice on fatigue and diurnal salivary cortisol concentration in breast cancer survivors. Banasik, J., Williams, H., Haberman, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6041937/

Yoga Program for High-Grade Glioma Patients Undergoing ... All patients (mean age: 52 years, 80% female, 80% grade IV) and caregivers (mean age: 58 years, 80% female, 60% spouses) perceived benefit from the program.

2. withpower.com withpower.com/trial/phase-glioma-5-2015-3f6f4

Couples-Based Yoga for Brain Cancer · Info for Participants A couple-based Hatha yoga program may improve fatigue, distress, sleep quality, and overall quality of life in patients with glioma and their partners. Show ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02481349

Couples-Based Yoga Program in Improving Quality of Life ... A couple-based Hatha yoga program may improve fatigue, distress, sleep quality, and overall quality of life in patients with glioma and their partners. Detailed ...

4. ascopubs.org ascopubs.org/doi/10.1200/jco.2016.34.26_suppl.200

Yoga program for patients with brain tumors undergoing ... Paired t-tests revealed a marginally significant, yet clinically meaningful, decrease in patient's cancer symptoms (t = 2.32, p = .08; MDASI ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2015-01124

Couples-Based Yoga Program in Improving Quality of Life ... A couple-based Hatha yoga program may improve fatigue, distress, sleep quality, and overall quality of life in patients with glioma and their partners.

6. oncnursingnews.com oncnursingnews.com/view/couples-based-yoga-improves-quality-of-life-for-patients-and-caregivers

Couples-Based Yoga Improves Quality of Life for Patients ... A recent study found that yoga could improve overall quality of life for patients with high grade glioma, as well as their caregivers.