Yoga for Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Regular yoga, Cognitive deficits, others

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

Compensation: Varies

Number of Visits: 21

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a yoga program, specifically the Dyadic Yoga Intervention, can improve the quality of life for people with head and neck cancer and their caregivers during radiotherapy. The focus is on reducing fatigue, sleep problems, and depressive feelings while assessing physical abilities like standing up from a chair and grip strength. Participants include those diagnosed with head and neck cancer undergoing at least four weeks of radiotherapy, along with a family caregiver willing to join them. As an unphased trial, this study provides a unique opportunity for patients and caregivers to explore innovative supportive care strategies that may enhance their well-being during treatment.

Will I have to stop taking my current medications?

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 this yoga program is safe for head and neck cancer patients?

Research has shown that yoga therapy is a safe option for head and neck cancer patients undergoing radiation treatment. Studies have found that yoga is not only feasible and well-received but also potentially beneficial during treatment. It is generally gentle on the body, with no serious side effects reported.

In these studies, patients who practiced yoga experienced overall improvement and found daily activities easier to manage. The evidence suggests that yoga can be a gentle and supportive addition to regular cancer care, with a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dyadic Yoga Intervention for head and neck cancer because it offers a holistic approach that integrates both physical and emotional support. Unlike traditional treatments that primarily focus on medical interventions like surgery, radiation, or chemotherapy, this yoga program encourages patients to engage in therapeutic exercise with a partner, enhancing emotional well-being and potentially improving quality of life. This approach not only addresses the physical aspects of recovery but also strengthens the caregiving relationship, which can be crucial during treatment. By exploring the benefits of partner-based yoga, researchers hope to find new ways to support patients beyond conventional medical treatments.

What evidence suggests that this dyadic yoga program is effective for head and neck cancer patients?

This trial will compare a partner-based yoga program with a waitlist control group for patients with head and neck cancer. Studies have shown that yoga therapy can effectively support these patients. A yoga program can enhance their quality of life, especially during treatments like chemotherapy and radiation. Research indicates that practicing yoga with a partner is feasible and may help reduce fatigue, sleep issues, and feelings of depression. Additionally, patients who practice yoga have reported overall improvement in well-being. These findings suggest that yoga could be a promising support method during cancer treatment. ^{1 2 5 6 7}

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 adults over 18 with head and neck cancer who are about to undergo at least 4 weeks of radiotherapy. They must be able to consent, have a performance status of 2 or lower, speak English, and not practice yoga regularly before diagnosis. A family caregiver willing to join the yoga sessions is also required.

Inclusion Criteria

I can take care of myself but cannot do heavy physical work.

I have head or neck cancer and will undergo radiation therapy for at least 4 weeks.

Able to provide informed consent

Exclusion Criteria

Cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team

You have been regularly practicing yoga in the year before being diagnosed.

Those who participate in phase 1 are ineligible to participate in phase 2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants undergo radiation therapy while participating in the dyadic yoga program or completing questionnaires

6 weeks

Weekly visits for radiation therapy and yoga sessions

Yoga Program

Participants in Group 1 take part in up to 15 yoga sessions during radiation therapy

6 weeks

Up to 15 yoga sessions, either in-person or via videoconferencing

Follow-up

Participants are monitored for quality of life and other outcomes after completion of radiation therapy

6 weeks

Questionnaires completed 6 weeks after radiation therapy

What Are the Treatments Tested in This Trial?

Interventions

• Dyadic Yoga Intervention

Trial Overview The study tests a dyadic yoga program's feasibility for patients with head and neck cancer undergoing radiotherapy and their caregivers. It looks at how this program might affect quality of life, including fatigue, sleep issues, mood, physical strength (like grip), and overall well-being.

How Is the Trial Designed?

Group I: Yoga Program Group Experimental Treatment 3 Interventions

Participants take part in the partner-based yoga program. Questionnaire completed during each week of radiation therapy about participant's feelings about the yoga sessions. Questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later).

Group II: Waitlist Control Group (WLC) Experimental Treatment 1 Intervention

Participants receive standard of care. Questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later). After the study has been completed, participant and caregiver/alternative caregiver offered the opportunity to take part in the partner-based yoga program.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11349719/

Dyadic Yoga for Head and Neck Cancer Patients Undergoing ... Yoga therapy appears to be a feasible, acceptable, and possibly efficacious behavioral supportive care strategy for HNC patients undergoing chemoradiation.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04890834

Study Details | NCT04890834 | Dyadic Yoga Intervention ... This study evaluates if partner-based (dyadic) yoga programs may improve the quality of life of patients with head and neck cancer undergoing chemoradiation and ...

3. jpsmjournal.com jpsmjournal.com/article/S0885-3924(24)00650-X/abstract

Dyadic Yoga for Head and Neck Cancer Patients ... Conclusion. Yoga therapy appears to be a feasible, acceptable, and possibly efficacious behavioral supportive care strategy for HNC patients ...

4. healio.com healio.com/news/hematology-oncology/20231031/yogabased-intervention-benefits-patients-with-head-and-neck-cancer

Yoga-based intervention benefits patients with head and ... A yoga-based intervention provided beneficial supportive care among a cohort of patients undergoing radiotherapy for head and neck cancer ...

5. cancertherapyadvisor.com cancertherapyadvisor.com/news/trial-of-a-dyadic-yoga-program-for-patients-with-head-and-neck-cancer/

Trial of A Dyadic Yoga Program for Patients With Head and ... Partner-based yoga program is feasible and will improve overall quality of life among patients with head and neck cancer.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38447621/

Dyadic Yoga for Head and Neck Cancer Patients Undergoing ... Yoga therapy appears to be a feasible, acceptable, and possibly efficacious behavioral supportive care strategy for HNC patients undergoing chemoradiation.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03948100

Study Details | NCT03948100 | Dyadic Yoga Intervention in ... This trial studies how well dyadic yoga intervention works in improving physical performance and quality of life in patients with stage I-IV non-small cell ...