Breathing Practice for Brain and Mental Health in Cancer and Neurodegenerative Diseases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

- STUDY 1: Should read and understand English well enough to consent, complete measures, and follow instructions.

- STUDY 1: Must have access to a smartphone or tablet.

- STUDY 2: Participants must be physically fit enough to perform light exercise.

- STUDY 2: Cancer patients may have prostate cancer, neuroendocrine tumor, or brain cancer in any stage.

- STUDY 2: The main focus is on pairs of cancer patients and their respective caregivers, but individual cancer patients or individual caregivers are also acceptable.

- STUDY 2: Participants should read and understand English well enough to consent, complete measures, and follow instructions.

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

- STUDY 3: Participants must be physically fit enough to perform light exercise.

- STUDY 3: The patient should have multiple sclerosis.

- STUDY 3: Participants should read and understand English well enough to consent, complete measures, and follow instructions.

- STUDY 3: They also 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: Additionally, those with chronic medical conditions, including heart disease (coronary artery disease, congestive heart failure, hypertension, cardiac arrhythmia), chronic obstructive pulmonary disease (COPD), cystic fibrosis, cancer, diabetes, sleep apnea, aneurysms, and neurological conditions (epilepsy, Alzheimer's disease, Huntington' disease, essential tremor and Parkinson disease) are excluded.

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

- STUDY 1: Participants serving as caregivers for any of the aforementioned conditions and for other illnesses such as cancer or neurological disorders, are also excluded.

- STUDY 1: Further exclusions apply to those with severe vision, hearing impairments, have a body mass index (BMI) over 30, and those who are pregnant.

- STUDY 1: Those planning to become pregnant during the study period will be excluded.

- STUDY 2: Participants incompatible with MRI machines due to factors such as pacemakers or metallic implants are excluded, as are those with chronic lung disease (chronic obstructive pulmonary disease [COPD], cystic fibrosis), aneurysms, and those who are pregnant.

- STUDY 2: Those planning to become pregnant during the study period will be excluded.

- STUDY 3: Participants incompatible with MRI machines due to factors such as pacemakers or metallic implants are excluded, as are those with chronic lung disease (chronic obstructive pulmonary disease [COPD], cystic fibrosis), aneurysms, and those who are pregnant.

- STUDY 3: Those planning to become pregnant during the study period will be excluded.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06788886
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Paul H. Min, PhD
Principal Investigator Affiliation	Mayo Clinic in Rochester
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Malignant Brain Neoplasm, Malignant Solid Neoplasm, Multiple Sclerosis, Neuroendocrine Tumor, Prostate Carcinoma
Study Website:	View Trial Website

Additional Details

PRIMARY OBJECTIVE:

I. To evaluate the immediate and long-term effects of improved respiratory function on local tissue oxygen delivery and cerebral circulation, by comparing control and training groups.

SECONDARY OBJECTIVE:

I. To identify key biological aspects of breathing related to brain health and mental well-being, our research explores how respiratory function can improve clinical symptoms related to fatigue and emotional states.

EXPLORATORY OBJECTIVE:

I. To establish a clinically applicable support tool that uses effective breathing practice to help patients, and their caregivers better navigate their clinical treatment.

OUTLINE: Participants are assigned to 1 of 3 studies. STUDY 1: Participants are randomized to 1 of 2 groups. GROUP 1: 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. At month 4, participants are randomized to 1 of 2 subgroups. SUBGROUP 1: Participants 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. SUBGROUP 2: Participants discontinue breathing self-practice routines for the additional 2 months on study. Participants also undergo MRI scans throughout the study. GROUP 2: 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. At month 4, participants are randomized to 1 of 2 subgroups. SUBGROUP 3: Participants 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. SUBGROUP 4: Participants 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. STUDY 2: 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. STUDY 3: 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. At month 4, participants are randomized to 1 of 2 subgroups. SUBGROUP 5: MS patients 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. SUBGROUP 6: MS patients discontinue breathing self-practice routines for the additional 2 months on study. Patients also undergo MRI scans and blood sample collection throughout the study.

Arms & Interventions

Arms

Experimental: Study 1 Group 1, Subgroup 1 (6 month breathing sessions)

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.

Experimental: Study 1 Group 1, Subgroup 2 (4 month breathing sessions)

Active Comparator: Study 1 Group 2, Subgroup 3 (6 month walking routines)

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

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.

Experimental: Study 2 (4 month breathing sessions)

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.

Experimental: Study 3 Subgroup 5 (6 month breathing sessions)

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.

Experimental: Study 3 Subgroup 6 (4 months breathing sessions)

Interventions

Procedure: - Biospecimen Collection

Undergo blood sample collection

Other: - Exercise Intervention

Participate in walking routines

Procedure: - Magnetic Resonance Imaging

Undergo MRI

Other: - Questionnaire Administration

Ancillary studies

Procedure: - Respiratory Therapy

Participate in breathing sessions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

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