Breathing Practice for Multiple Sclerosis and Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Heart disease, COPD, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

147 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Breathing Practice for Multiple Sclerosis and Cancer?

Research shows that deep breathing can help reduce anxiety and fatigue in cancer patients, and breathing exercises as part of yoga programs have been beneficial for people with multiple sclerosis, improving their quality of life and symptom management. ^{1 2 3 4 5}

Is breathing practice safe for people with multiple sclerosis?

Breathing practices, including those used in yoga and mind-body therapies, are generally considered safe for people with multiple sclerosis and may offer non-drug benefits for managing symptoms. ^{2 6 7 8 9}

How does the breathing practice treatment differ from other treatments for multiple sclerosis and cancer?

The breathing practice treatment is unique because it focuses on mind-body techniques like meditation and deep breathing, which aim to improve quality of life, mood, and reduce stress and fatigue, rather than directly targeting the disease itself. This approach is different from conventional treatments that typically involve medication or surgery. ^{1 3 4 10 11}

What is the purpose of this trial?

This clinical trial studies the effect of respiratory training for enhancing brain and mental health among patients with multiple sclerosis (MS) and cancer (along with their caregivers). The relationship between respiration, cardiovascular effects in the brain, mental health, and neurophysiological mechanisms are significant for patient populations facing complex health challenges, such as those with cancer and neurodegenerative disease, and their caregivers. By measuring oxygen delivery to brain tissues and cerebrospinal fluid flow, this trial may help researchers investigate the potential benefits of respiratory training for patients with MS and cancer and their caregivers.

Research Team

Paul H. Min, PhD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for patients with multiple sclerosis or various cancers, including neuroendocrine and prostate cancer, as well as their caregivers. It aims to explore how breathing exercises can improve brain and mental health.

Inclusion Criteria

STUDY 2: They also must have access to a smartphone or tablet

STUDY 1: Participants must be physically fit enough to perform light exercise

STUDY 1: Must have access to a smartphone or tablet

Exclusion Criteria

STUDY 1: Participants incompatible with MRI machines due to factors such as pacemakers or metallic implants

STUDY 1: Participants with psychiatric conditions such as psychosis, suicidality, bipolar disorder, major depression, and substance use disorders are excluded

I do not have chronic conditions like heart disease, COPD, diabetes, or neurological disorders.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in breathing or walking self-practice routines using a mobile app over 30 minutes daily for 4 months. Participants may participate in real-time online or in-person sessions with instructors.

4 months

Weekly online sessions, monthly in-person sessions

Extended Treatment

Participants continue or discontinue their self-practice routines for an additional 2 months, with some groups combining breathing and walking practices.

2 months

Weekly online sessions, monthly in-person sessions

Follow-up

Participants are monitored for changes in respiratory function, brain activity, and quality of life measures using MRI and various questionnaires.

2 months

Treatment Details

Interventions

• Breathing Practice

Trial Overview The study tests respiratory training's effects on the brain and mental health by using questionnaires, MRI scans, biospecimen collection, and exercise interventions to measure changes in oxygen delivery to the brain.

Participant Groups

Group I: Study 3 Subgroup 6 (4 months breathing sessions) Experimental Treatment 4 Interventions

MS patients engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. MS patients then discontinue breathing self-practice routines for the additional 2 months on study. Patients also undergo MRI scans and blood sample collection throughout the study.

Group II: Study 3 Subgroup 5 (6 month breathing sessions) Experimental Treatment 4 Interventions

MS patients engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. MS patients then engage in breathing self-practice routines using a mobile app over 30 minutes daily for an additional 2 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Patients also undergo MRI scans and blood sample collection throughout the study.

Group III: Study 2 (4 month breathing sessions) Experimental Treatment 3 Interventions

Cancer patients and their caregivers engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants also undergo MRI scans throughout the study.

Group IV: Study 1 Group 2, Subgroup 4 (walking + breathing) Experimental Treatment 4 Interventions

Participants engage in walking self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants then engage in walking self-practice routines using a mobile app over 30 minutes daily for an additional 2 months and also engage in breathing self-practice routines using a mobile app over 30 minutes daily for 2 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants also undergo MRI scans throughout the study.

Group V: Study 1 Group 1, Subgroup 2 (4 month breathing sessions) Experimental Treatment 3 Interventions

Participants engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants then discontinue breathing self-practice routines for the additional 2 months on study. Participants also undergo MRI scans throughout the study.

Group VI: Study 1 Group 1, Subgroup 1 (6 month breathing sessions) Experimental Treatment 3 Interventions

Participants engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants then engage in breathing self-practice routines using a mobile app over 30 minutes daily for an additional 2 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants also undergo MRI scans throughout the study.

Group VII: Study 1 Group 2, Subgroup 3 (6 month walking routines) Active Control 3 Interventions

Participants engage in walking self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants then engage in walking self-practice routines using a mobile app over 30 minutes daily for an additional 2 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants also undergo MRI scans throughout the study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

In a study involving 23 Japanese women with gynaecological cancer undergoing chemotherapy, a 10-minute deep breathing intervention significantly reduced 'tension-anxiety' and fatigue compared to a control group.

The results suggest that deep breathing can be an effective complementary therapy to help alleviate emotional and physical distress in cancer patients during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of deep breathing on 'tension-anxiety' and fatigue in cancer patients undergoing adjuvant chemotherapy. Hayama, Y., Inoue, T.[2022]

An 8-week online adaptive yoga program for patients with multiple sclerosis was found to be safe and enjoyable, with all participants reporting perceived benefits from their involvement.

Participants not only experienced improvements in their perceived symptom severity and quality of life but also valued the social interaction with fellow patients during the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring an 8-Week Online Adaptive Yoga Program for Multiple Sclerosis: A Pilot Study. Robert, MK., Hales Reynolds, MA., Eisenberg, M., et al.[2023]

In a study of 60 women undergoing radiation therapy for breast cancer, those practicing pranayama showed improved sleep quality, while the control group experienced increased fatigue levels by the end of treatment.

Pranayama is a simple and equipment-free exercise that can be easily taught by oncology nurses, making it a practical option for managing symptoms like fatigue and sleep disturbances in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Pranayama or Deep Breathing Exercises on Fatigue and Sleep Quality in Women Receiving Radiation Therapy for Breast Cancer. Gündogdu, F., Koçaşlı, S.[2023]

Participation in an 8-week mindfulness-based stress reduction (MBSR) program significantly improved quality of life, reduced stress symptoms, and enhanced sleep quality in 59 cancer patients (49 with breast cancer and 10 with prostate cancer).

The study also revealed changes in cytokine production, indicating a shift in immune response, with increased IL-4 and decreased IFN-gamma and IL-10, suggesting a move towards a healthier immune profile associated with reduced depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Carlson, LE., Speca, M., Patel, KD., et al.[2023]

In a pilot study involving 30 cancer patients, those who participated in an 8-week Medical Qigong (MQ) program reported clinically significant improvements in their quality of life (QOL) compared to those receiving only usual medical care.

The MQ intervention also showed potential in reducing treatment side effects and inflammation, as indicated by lower levels of the inflammation biomarker (CRP), although the small sample size limited the statistical significance of these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Qigong for cancer patients: pilot study of impact on quality of life, side effects of treatment and inflammation. Oh, B., Butow, P., Mullan, B., et al.[2019]

The LoveYourBrain Yoga program, a six-week intervention for people with multiple sclerosis, significantly reduced fatigue, anxiety, and improved overall wellbeing, demonstrating its effectiveness in a community-based setting with 15 participants.

Participants reported high satisfaction with the program, with 92.3% indicating they would recommend it to others, highlighting its acceptability and potential as a supportive therapy for managing MS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A crossover pilot trial of the feasibility, acceptability, and effectiveness of LoveYourBrain Yoga for community-dwelling adults with multiple sclerosis. Donnelly, KZ., Jeffreys, C., MacKenzie, T., et al.[2022]

A randomized controlled trial involving 48 patients with mild to moderate multiple sclerosis showed that 2 months of home-based breathing exercises significantly improved lung function, specifically vital capacity and forced vital capacity, compared to a control group.

While the breathing exercises demonstrated some benefits, the long-term clinical significance and potential for delaying respiratory dysfunction in MS patients still need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep breathing exercises with positive expiratory pressure in patients with multiple sclerosis - a randomized controlled trial. Westerdahl, E., Wittrin, A., Kånåhols, M., et al.[2017]

Engaging in physical and relaxation activities is linked to significantly lower rates of depression (40% and 33% reductions, respectively) and lower fatigue (19% reduction) in individuals with multiple sclerosis, suggesting these activities can improve mental health outcomes.

Meditation not only correlates with a 30% reduction in depression and a 17% increase in mastery but also shows promising long-term benefits, with a 28% decrease in depression and a 48% reduction in the risk of developing depression over five years, highlighting its potential as a safe and effective preventive intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undertaking specific stress-reducing activities are associated with reduced fatigue and depression, and increased mastery, in people with multiple sclerosis. Nag, N., Yang, X., Jelinek, G., et al.[2022]

Mind-body therapies, including yoga, mindfulness, relaxation, and biofeedback, have shown promise in managing various symptoms of multiple sclerosis, based on a review of 11 studies.

While the evidence is limited, these therapies are considered relatively safe and may offer a beneficial non-drug approach to symptom management in multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-body medicine for multiple sclerosis: a systematic review. Senders, A., Wahbeh, H., Spain, R., et al.[2021]

The pilot study of the 'Breathe Easier' mindfulness-based intervention showed strong feasibility among 62 participants, with 79% completing the 8-week program, indicating that such interventions can be effectively implemented for lung cancer survivors and their families.

Participants who engaged in level 1 yoga reported significant improvements in dyspnea, fatigue, sleep quality, and stress, while level 2 participants showed mixed results, highlighting the need for tailored approaches in mindfulness interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Pilot Study Evaluating Feasibility and Preliminary Effects of Breathe Easier: A Mindfulness-based Intervention for Survivors of Lung Cancer and Their Family Members (Dyads). McDonnell, KK., Gallerani, DG., Newsome, BR., et al.[2021]

A clinical trial involving 40 hospitalized cancer patients tested two meditation practices, Isha Kriya (IK) and meditative slow breathing (MSB), showing that both practices were acceptable, with 12 out of 15 participants responding positively to the meditation experience by day 7.

The study faced challenges in feasibility, as only 39% of eligible patients participated, and factors like high morbidity and limited time for meditation hindered consistent practice, suggesting that future research should focus on shorter-term outcomes and better support for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Feasibility Study of Meditative Practices in Hospitalized Cancer Patients. Narayanan, S., Reddy, A., Lopez, G., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

The effects of deep breathing on 'tension-anxiety' and fatigue in cancer patients undergoing adjuvant chemotherapy. [2022]

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

Exploring an 8-Week Online Adaptive Yoga Program for Multiple Sclerosis: A Pilot Study. [2023]

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

The Effects of Pranayama or Deep Breathing Exercises on Fatigue and Sleep Quality in Women Receiving Radiation Therapy for Breast Cancer. [2023]

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

Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. [2023]

5. Singapore pubmed.ncbi.nlm.nih.gov

Medical Qigong for cancer patients: pilot study of impact on quality of life, side effects of treatment and inflammation. [2019]

6. England pubmed.ncbi.nlm.nih.gov

A crossover pilot trial of the feasibility, acceptability, and effectiveness of LoveYourBrain Yoga for community-dwelling adults with multiple sclerosis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Deep breathing exercises with positive expiratory pressure in patients with multiple sclerosis - a randomized controlled trial. [2017]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Undertaking specific stress-reducing activities are associated with reduced fatigue and depression, and increased mastery, in people with multiple sclerosis. [2022]

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

Mind-body medicine for multiple sclerosis: a systematic review. [2021]

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

A Prospective Pilot Study Evaluating Feasibility and Preliminary Effects of Breathe Easier: A Mindfulness-based Intervention for Survivors of Lung Cancer and Their Family Members (Dyads). [2021]

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

Randomized Feasibility Study of Meditative Practices in Hospitalized Cancer Patients. [2021]