Yoga for Head and Neck Cancer

Overseen By Kathrin Milbury, MA,PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Regular yoga participation

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

Compensation: Varies

Number of Visits: 18

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if yoga can improve the quality of life for head and neck cancer patients undergoing chemoradiation and their caregivers. The study compares standard care alone to standard care plus partner-based yoga sessions (Dyadic Yoga Intervention). Patients with a family caregiver willing to participate in yoga sessions and who have not practiced yoga in the past year might be suitable candidates. The trial also explores whether adding yoga can reduce hospital visits during and after treatment. As an unphased trial, participants contribute to innovative research that could enhance cancer care and support.

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

What prior data suggests that this yoga program is safe for patients with head and neck cancer?

Research has shown that yoga therapy offers a safe and promising way to support patients with head and neck cancer during treatment. Studies have found this type of yoga to be feasible, well-received, and potentially beneficial. For instance, patients undergoing chemotherapy and radiation found yoga to be a helpful part of their care. No major safety issues or serious problems arose from the yoga sessions. This suggests that the yoga program, which includes both patients and their caregivers, is well-tolerated and could serve as a supportive addition to regular cancer care. ^{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 novel approach to enhancing patient and caregiver well-being. Unlike standard care, which includes symptom management and supportive services, this intervention adds a therapeutic exercise component through yoga sessions. These sessions aim to improve physical and mental health by promoting relaxation, reducing stress, and potentially boosting recovery. The integration of yoga could offer complementary benefits beyond what traditional medical treatments provide, addressing both the physical and emotional challenges faced by patients and their caregivers.

What evidence suggests that dyadic yoga might be an effective treatment for head and neck cancer?

Research has shown that yoga therapy might help patients with head and neck cancer undergoing chemoradiation. Studies have found yoga to be a practical and acceptable support method for these patients. In this trial, one group will receive standard care, while another will participate in a yoga program designed to enhance the quality of life for both patients and their caregivers. The partner-based yoga program aims to boost well-being for both groups. Overall, early evidence suggests yoga could be a helpful addition to standard cancer care. ^{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 adult patients with head and neck cancer scheduled for chemoradiation, who have a caregiver willing to participate. Both must be English-speaking, able to consent, and not already practicing yoga regularly.

Inclusion Criteria

PATIENTS: Having a family caregiver (e.g., spouse/partner, sibling, adult child) willing to participate

I have head and neck cancer and will undergo at least 5 weeks of combined chemotherapy and radiation.

I am able to get out of my bed or chair and move around.

Exclusion Criteria

You or your caregiver have practiced yoga on a regular basis in the year before you were diagnosed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemoradiation therapy and participate in yoga sessions 3 times per week for a total of 15 sessions

5 weeks

15 yoga sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up assessments every 2 weeks for 3 months and then monthly for up to 6 months

6 months

Bi-weekly visits for 3 months, then monthly visits

What Are the Treatments Tested in This Trial?

Interventions

• Dyadic Yoga Intervention

Trial Overview The study tests if a partner-based yoga program can improve life quality and reduce hospital visits for both patients undergoing chemoradiation for head and neck cancer and their caregivers.

How Is the Trial Designed?

Group I: Arm II (exercise, yoga sessions) Experimental Treatment 3 Interventions

Patients and caregivers receive standard care as in arm I. Patients and caregivers also participate in yoga sessions 3 times per week over 60 minutes each for a total of 15 sessions.

Group II: Arm I (Standard of care) Active Control 2 Interventions

Patients and caregivers receive standard care including education pertaining to symptom management, prophylactic dental hygiene and possible extraction, speech pathology for baseline swallowing assessment and prophylactic treatment, and dietary services for regular nutrition consults during CRT. Psychiatry, social work, interventional radiology and supportive care services are consulted as needed.

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

The individualized mindfulness-based stress reduction (IMBSR) program was feasible and acceptable for 19 head and neck cancer patients undergoing treatment, suggesting it can be integrated into their care.

Higher levels of post-intervention mindfulness were linked to lower psychological distress and improved quality of life, indicating that mindfulness practices may benefit patients during active cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualised mindfulness-based stress reduction for head and neck cancer patients undergoing radiotherapy of curative intent: a descriptive pilot study. Pollard, A., Burchell, JL., Castle, D., et al.[2022]

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]

The SHARE intervention significantly improved positive dyadic coping behaviors among head and neck cancer patients and their spouses, leading to better psychological outcomes, such as reduced depression and anxiety, with moderate to large effect sizes.

Improvements in positive dyadic coping were linked to enhanced marital adjustment, suggesting that fostering supportive communication and actions between couples can be beneficial during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyadic Coping in Patients Undergoing Radiotherapy for Head and Neck Cancer and Their Spouses. Badr, H., Herbert, K., Bonnen, MD., et al.[2023]

A randomized controlled trial involving 26 patient-caregiver dyads showed that a 15-session dyadic yoga intervention significantly improved physical function and walking distance in patients undergoing thoracic radiotherapy compared to a waitlist control group.

Caregivers also experienced marginal improvements in vitality and role performance, suggesting that the dyadic yoga program benefits both patients and their caregivers during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyadic yoga program for patients undergoing thoracic radiotherapy and their family caregivers: Results of a pilot randomized controlled trial. Milbury, K., Liao, Z., Shannon, V., et al.[2020]

Psychooncological interventions are designed to help cancer patients, particularly those with head and neck cancer, cope with their illness and improve their psychological well-being and quality of life.

These interventions utilize established psychological methods and rely on teamwork among various healthcare professionals to address the unique challenges faced by head and neck cancer patients, who often experience significant distress and functional impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychooncological Treatment of Patients with Head and Neck Cancer]. Moschen, R., Riedl, D.[2018]

Among 30 head-and-neck cancer patients surveyed, 63% expressed interest in mind-body interventions (MBIs) to help manage psychosocial distress, indicating a significant demand for such support.

The study found no significant differences in levels of depression, anxiety, or sleep disturbance based on interest in MBIs, suggesting that while patients are interested in these interventions, their current psychosocial distress levels may not influence that interest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial distress and the preferred method of delivery of mind-body interventions among patients with head-and-neck cancer. Budhrani-Shani, P., Chau, NG., Berry, DL.[2022]

This study aims to assess the feasibility of implementing dyadic yoga (DY) and caregiver yoga (CY) interventions for glioma patients and their caregivers, involving 75 participants over 15 sessions during 6 weeks of radiotherapy.

The primary goal is to determine if at least 50% of eligible dyads consent to participate and if 70% complete all assessments, which will help inform future larger trials on the impact of yoga on symptoms and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A research protocol for a pilot, randomized controlled trial designed to examine the feasibility of a dyadic versus individual yoga program for family caregivers of glioma patients undergoing radiotherapy. Milbury, K., Li, J., Weathers, SP., et al.[2023]

A tailored hatha yoga program for head and neck cancer survivors was found to be feasible, with high participant retention and satisfaction, and no adverse events reported during the 8-week intervention.

Preliminary efficacy data suggested that the yoga program may improve shoulder range of motion, reduce pain, and decrease anxiety in participants, indicating potential benefits for managing long-term treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Efficacy of Tailored Yoga in Survivors of Head and Neck Cancer: A Pilot Study. Adair, M., Murphy, B., Yarlagadda, S., et al.[2019]

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]

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]

Both meditation techniques—meditation with a coach and self-meditation with a CD—were effective in reducing anxiety, depression, and emotional distress in patients undergoing radiation therapy for head and neck cancer, as shown in a study of 28 patients over 12 weeks.

Self-meditation with a CD was found to be a more cost-effective option compared to meditation with a coach, making it a practical choice for patients facing high stress during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Two Types of Meditation on Patients' Psychosocial Responses During Radiation Therapy for Head and Neck Cancer. Boxleitner, G., Jolie, S., Shaffer, D., et al.[2017]

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 ...