Yoga for Non-Small Cell Lung Cancer

Overseen By Kathrin Milbury, MA,PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Mind-body practice, CNS metastasis

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

Compensation: Varies

Number of Visits: 2

Duration: 15 sessions

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well dyadic yoga can improve physical performance and quality of life for individuals with stage I-IV non-small cell lung or esophageal cancer undergoing radiotherapy, along with their caregivers. Dyadic yoga involves both the patient and a caregiver participating in yoga sessions together, potentially aiding physical function, fatigue, sleep issues, and depressive symptoms. The trial compares this to a dyadic education program focused on symptom management. It suits those diagnosed with these cancers who will receive at least three weeks of chest radiotherapy and have a caregiver assisting them. As an unphased trial, this study provides a unique opportunity to explore innovative supportive care options that could enhance 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 dyadic yoga intervention is safe for patients with non-small cell lung cancer and their caregivers?

Research shows that yoga is generally safe for people with cancer, including those who have undergone treatments like radiotherapy. Studies have explored the benefits of a yoga program for patients with non-small cell lung cancer. Results suggest that participants can practice yoga with ease.

Earlier research reported very few side effects among those practicing yoga, indicating that the yoga program in this trial is expected to be safe for participants. This trial tests a form of exercise and relaxation, not a new drug or medical procedure, so the risk of serious side effects is low. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the dyadic yoga intervention for non-small cell lung cancer because it offers a holistic approach that combines physical exercises and relaxation techniques. Unlike traditional treatments, which often focus solely on medical interventions like chemotherapy or radiation, this yoga method emphasizes the well-being of both patients and caregivers. It aims to enhance quality of life by reducing stress and improving physical function, potentially offering a complementary strategy alongside existing medical therapies.

What evidence suggests that dyadic yoga intervention is effective for improving quality of life in non-small cell lung cancer patients?

Research has shown that practicing yoga together can enhance physical well-being and quality of life for people with non-small cell lung cancer. In this trial, participants in Group I will engage in a dyadic yoga intervention, where patients and their caregivers participate in 15 yoga sessions. One study found that these sessions made participants feel stronger, less tired, and improved their sleep. Participants also exhibited fewer signs of depression and experienced an overall improvement in quality of life. These benefits suggest that yoga can effectively support both patients and their caregivers during cancer treatment. ^{1 4 6 7 8}

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 patients with stage I-IV non-small cell lung or esophageal cancer who are about to undergo at least 3 weeks of thoracic radiotherapy. They must be able to perform daily activities (ECOG <=2), speak English, and consent. Caregivers can join optionally if they're adults, speak English, and give consent. People practicing mind-body techniques in the past year or with brain metastases cannot join.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

I have lung or esophageal cancer and will undergo 3 weeks of chest radiation.

Able to provide informed consent

Exclusion Criteria

I have regularly practiced mind-body techniques like meditation or yoga before my diagnosis.

My cancer has spread to my brain or spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dyadic yoga intervention or dyadic education program for up to 15 sessions, each lasting 60 minutes

15 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Every 2 weeks for 3 months, then monthly for up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Dyadic Yoga Intervention

Trial Overview The study tests a dyadic yoga program's effectiveness on improving physical performance and life quality for both patients undergoing radiotherapy for certain cancers and their caregivers. It includes assessments through questionnaires and an educational component alongside the yoga intervention.

How Is the Trial Designed?

Group I: Group I (dyadic yoga) Experimental Treatment 3 Interventions

Patients and caregivers undergo dyadic yoga intervention session involving physical exercises and relaxation techniques over 60 minutes each for up to 15 sessions.

Group II: Group II (dyadic education) Active Control 3 Interventions

Patients and caregivers undergo dyadic education program session focusing on strategies of how to manage patient and caregiver symptoms over 60 minutes each for up to 15 sessions.

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

Yoga significantly reduces distress, anxiety, and depression in cancer patients undergoing radiotherapy, indicating its potential as a supportive therapy during treatment.

While yoga shows moderate benefits for fatigue and emotional function, the evidence for its effects on overall psychological outcomes and functional well-being is limited, suggesting the need for further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing Yoga in Oncologic Patients Treated with Radiotherapy: Review. Tolia, M., Tsoukalas, N., Nikolaou, M., et al.[2022]

Yoga interventions for adults undergoing cancer treatment have been shown to significantly improve psychological outcomes such as depression, anxiety, and distress, based on a review of 21 studies.

There is emerging evidence that yoga may also enhance quality of life and alleviate physical symptoms like sleep disturbances and fatigue, although more research is needed to confirm these benefits and explore specific areas of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of yoga therapy during cancer treatment. Danhauer, SC., Addington, EL., Sohl, SJ., et al.[2021]

A 12-week pilot trial involving 46 patients with lung cancer showed that a low-moderate intensity yoga program significantly improved psychosocial outcomes like fatigue, depression, and sleep disturbance in 54% of participants, along with quality of life improvements in 77%.

The study also found that physical functions such as flexibility and strength improved in a high percentage of participants, with no serious adverse events reported, suggesting that partner-supported yoga could be a safe and beneficial complementary therapy during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and potential benefits of partner-supported yoga on psychosocial and physical function among lung cancer patients. Sullivan, DR., Medysky, ME., Tyzik, AL., 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]

A 14-week yoga intervention was feasible for 7 survivors of non-small cell lung cancer (NSCLC), with participants able to practice without respiratory distress and maintaining over 95% attendance.

The yoga program led to significant improvements in mood, sleep quality, and overall quality of life, along with a decrease in salivary cortisol levels, suggesting potential benefits for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of the feasibility and outcomes of yoga for lung cancer survivors. Fouladbakhsh, JM., Davis, JE., Yarandi, HN.[2014]

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]

The Vivekananda Yoga intervention was found to be feasible and acceptable for lung cancer patients and their caregivers, with 60% of participants completing the program and 95.5% rating it as very useful.

Significant improvements were observed in patients' mental health and caregivers' sleep disturbances, indicating potential benefits for quality of life outcomes, although further research is needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vivekananda Yoga Program for Patients With Advanced Lung Cancer and Their Family Caregivers. Milbury, K., Mallaiah, S., Lopez, G., et al.[2022]

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6405285/

Dyadic Yoga Program for Patients Undergoing Thoracic ... Patients with stage I-III non-small cell lung or esophageal cancer undergoing TRT and their caregivers (N=26 dyads) were randomized to a 15-session DY or a ...

3. withpower.com withpower.com/trial/phase-lung-neoplasms-11-2018-54fbc

Yoga for Non-Small Cell Lung Cancer Dyadic yoga intervention may help to improve physical function, fatigue, sleep difficulties, depressive symptoms, and overall quality of life for patients with ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2017.35.31_suppl.125

Randomized controlled trial (RCT) of a dyadic yoga ... Methods: Non-small cell lung cancer patients undergoing RT and their caregivers were randomized to a 15-session yoga or a waitlist control (WLC) group.

5. reporter.nih.gov reporter.nih.gov/search/2OryzcGoqkygSuMg2rqokg/project-details/10694883

Dyadic yoga Program for Patients with Lung Cancer ... Based on the promising findings of our pilot data, we proposed to examine a dyadic yoga program in patients with lung cancer (LC) and their family caregivers.

6. reporter.nih.gov reporter.nih.gov/search/FGxAjxRLm0-7iItpqV1wDA/project-details/10818157

Dyadic yoga Program for Patients with Lung Cancer Undergoing ... The parent R37 project seeks to examine the efficacy of an instructor-led dyadic yoga program regarding improved objective physical function and QOL outcomes in ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/249801

Dyadic Yoga Intervention in Improving Physical ... This trial studies how well dyadic yoga intervention works in improving physical performance and quality of life in patients with stage I-IV ...

8. withpower.com withpower.com/trial/phase-carcinoma-non-small-cell-lung-8-2025-0c23a

Yoga Program for Non-Small Cell Lung Cancer Research shows that yoga is generally safe for people with cancer, including those who have undergone treatments like radiotherapy. It has been studied for ...