Yoga for Multiple Myeloma

Overseen By UACC IIT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Poor performance status, Other trial, Mental health, Fall, Others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

31 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the feasibility of implementing a weekly yoga intervention in patients with multiple myeloma on active therapy. This study aims to analyze the impact of yoga intervention on physical symptoms (e.g. pain, fatigue, sleep), psychological symptoms (e.g. anxiety, depression), and overall health-related quality of life (HRQOL) in multiple myeloma patients on active treatment.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It focuses on patients with multiple myeloma who are already on active treatment.

What data supports the effectiveness of the treatment Yoga for Multiple Myeloma?

Research on yoga for breast cancer patients shows it can improve quality of life, reduce depression, and manage symptoms like fatigue and stress. These benefits suggest yoga might also help people with multiple myeloma feel better and manage their symptoms. ^{1 2 3 4 5}

Is yoga generally safe for humans?

Research shows that yoga is generally safe for humans, with no significant differences in serious or nonserious adverse events compared to usual care or exercise. However, there may be more minor adverse events compared to psychological or educational interventions. ^{1 4 6 7 8}

How does yoga treatment differ from other treatments for multiple myeloma?

Yoga is a unique treatment for multiple myeloma as it focuses on improving quality of life by reducing physical and emotional symptoms like fatigue and anxiety, rather than directly targeting the cancer itself. Unlike traditional drug treatments, yoga is a non-drug, mind-body intervention that can be used alongside standard medical care to help patients cope with the challenges of cancer treatment. ^{1 9 10 11 12}

Research Team

Shaunak Pandya, MD

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for adults over 18 with multiple myeloma who are currently receiving treatment. Participants should be able to use a computer or smartphone, attend weekly yoga sessions at a studio, and understand English. They must be in good physical condition as judged by specific medical criteria and not involved in another clinical study.

Inclusion Criteria

Able to utilize a wearable device, such as Apple Watch or Fitbit (optional)

I am currently receiving treatment for multiple myeloma.

I am fully active or able to carry out light work.

Exclusion Criteria

Your doctor thinks your mental health symptoms are not well managed.

I do not have amyloidosis or another cancer needing treatment.

Actively participating in another clinical trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a weekly 40-minute guided mindful yoga intervention for 12 consecutive weeks

12 weeks

12 visits (in-person or remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Waitlist Yoga Intervention

Participants in the waitlist group start the yoga intervention at week 13 for 12 consecutive weeks

12 weeks

Treatment Details

Interventions

• Delayed yoga intervention
• Immediate yoga intervention

Trial Overview The study tests how feasible it is to have weekly yoga sessions for multiple myeloma patients undergoing treatment. It looks at the effects of yoga on physical discomforts like pain and fatigue, mental health issues such as anxiety, and overall life quality.

Participant Groups

Group I: Immediate yoga group Experimental Treatment 1 Intervention

20 participants randomized to immediate yoga intervention group will participate together in a weekly 40-minute guided mindful yoga intervention for a total of 12 consecutive weeks. After each session, participants will be asked to complete the Edmonton Symptom Assessment System (ESAS-r) through MyDataHelps app. At the end of each session, participants will be asked additional questions via MyDataHelps such as completion of yoga session on-site or remotely, the length of time they participated in the session, any additional yoga sessions during the past week, and comments regarding the session/intervention. These participants will also complete health-related quality of life (HRQOL) assessment (EORTC QLQ-C30) at baseline, 6 weeks, and 12 weeks during active yoga intervention.

Group II: Waitlist yoga group (delayed yoga intervention group) Active Control 1 Intervention

20 participants randomized to this group will start the yoga intervention at week 13 and participate in 12 consecutive weeks of weekly 40 minute guided mindful yoga. Participants in this group will complete ESAS-r every 3 weeks and EORTC QLQ-C30 every 6 weeks for the first 12 weeks. These participants will also complete HRQOL assessment (EORTC QLQ-C30) at baseline, 6 weeks, and 12 weeks during active yoga intervention, weeks 13-24.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Findings from Research

The Bali Yoga Program for Breast Cancer Patients (BYP-BC) effectively prevented an increase in depression symptoms among women undergoing chemotherapy, while the control group experienced a significant rise in these symptoms.

After the control group received the yoga intervention, their depression symptoms decreased, indicating that the BYP-BC program can be beneficial for managing psychological distress in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of the Bali Yoga Program (BYP-BC) on reducing psychological symptoms in breast cancer patients receiving chemotherapy: results of a randomized, partially blinded, controlled trial. Lanctôt, D., Dupuis, G., Marcaurell, R., et al.[2017]

In a study of 93 women with early breast cancer, those who started yoga immediately after surgery (intervention group) showed significant improvements in overall quality of life and functional status compared to those who began yoga 5 weeks post-surgery (control group).

86% of women in the intervention group reported increased physical activity due to yoga, and more women in this group expressed a desire to continue practicing yoga, highlighting the benefits of early yoga initiation as a supportive treatment in cancer recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga for Patients with Early Breast Cancer and its Impact on Quality of Life - a Randomized Controlled Trial. Siedentopf, F., Utz-Billing, I., Gairing, S., et al.[2021]

A review of 71 studies indicates that yoga can improve quality of life (QOL) for women undergoing breast cancer treatment, enhancing aspects like physical well-being, emotional health, and social functioning.

Despite the positive findings, the review highlights the need for more rigorous research to pinpoint which specific elements of yoga are most beneficial for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga and quality-of-life improvement in patients with breast cancer: a literature review. Levine, AS., Balk, JL.[2012]

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]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

A 12-week randomized controlled trial involving 78 adult cancer survivors showed that a yoga intervention was highly feasible and acceptable, with high attendance rates (75.5-89.5%) and no reported adverse events.

Participants expressed high satisfaction with the program (average rating of 4.8 out of 5), indicating that yoga can be a beneficial exercise option for improving health and well-being during cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a yoga, aerobic and stretching-toning exercise program for adult cancer survivors: the STAYFit trial. Gothe, NP., Erlenbach, E.[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 study involving 486 hospitalized patients with hematological cancer showed that a 40-minute individualized yoga therapy session was feasible, with 87% of sessions completed and no early terminations due to pain.

Patients reported significant reductions in symptoms such as fatigue and anxiety after the yoga sessions, indicating that yoga can be an effective non-drug intervention to improve quality of life during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized, Single Session Yoga Therapy to Reduce Physical and Emotional Symptoms in Hospitalized Hematological Cancer Patients. Mascaro, JS., Waller, AV., Wright, L., et al.[2020]

After educational interventions, interest in yoga among older veterans who are cancer survivors significantly increased from 5.5% to 31.8%, indicating that knowledge can enhance engagement with yoga as a therapeutic option.

Participation in a yoga program led to improved beliefs about its benefits and physical function, particularly for those who initially had higher expectations about yoga, suggesting that targeted interventions can effectively address barriers to access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Access to Yoga for Older Male Veterans After Cancer: Examining Beliefs About Yoga. Auguste, EJ., Weiskittle, RE., Sohl, SJ., et al.[2022]

In a study involving 227 women undergoing chemotherapy for breast cancer, a 4-session Tibetan yoga program significantly improved sleep quality and reduced depression symptoms compared to usual care, especially for those with poor sleep efficiency.

Baseline actigraphy-assessed sleep efficiency was a better predictor of who would benefit from the yoga intervention than self-reported sleep quality, indicating that women with lower sleep efficiency experienced the most improvement in sleep and mood after participating in the yoga program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep moderates the effects of Tibetan yoga for women with breast cancer undergoing chemotherapy. Sinclair, KL., Kiser, E., Ratcliff, CG., et al.[2022]

Mind-body interventions like hypnosis and imagery/relaxation have been shown to effectively control pain and reduce anxiety in cancer patients, enhancing their overall treatment experience.

Yoga and meditation are supported by randomized controlled trials for improving quality of life, mood, and sleep in cancer patients, highlighting the importance of these therapies in managing the emotional and physical challenges of cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-body interventions in oncology. Carlson, LE., Bultz, BD.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The effects of the Bali Yoga Program (BYP-BC) on reducing psychological symptoms in breast cancer patients receiving chemotherapy: results of a randomized, partially blinded, controlled trial. [2017]

2. Germany pubmed.ncbi.nlm.nih.gov

Yoga for Patients with Early Breast Cancer and its Impact on Quality of Life - a Randomized Controlled Trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Yoga and quality-of-life improvement in patients with breast cancer: a literature review. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Yoga for symptom management in oncology: A review of the evidence base and future directions for research. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Effect of yoga on patients with cancer: our current understanding. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a yoga, aerobic and stretching-toning exercise program for adult cancer survivors: the STAYFit trial. [2022]

8. United States 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. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Individualized, Single Session Yoga Therapy to Reduce Physical and Emotional Symptoms in Hospitalized Hematological Cancer Patients. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Enhancing Access to Yoga for Older Male Veterans After Cancer: Examining Beliefs About Yoga. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Sleep moderates the effects of Tibetan yoga for women with breast cancer undergoing chemotherapy. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Mind-body interventions in oncology. [2021]