Recruiting

Breathing Practice

Sponsor:

Mayo Clinic

Code:

NCT06788886

Conditions

Malignant Brain Neoplasm

Malignant Solid Neoplasm

Multiple Sclerosis

Neuroendocrine Tumor

Prostate Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Exercise Intervention

Magnetic Resonance Imaging

Questionnaire Administration

Respiratory Therapy

Study Details

Brief summary:

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.

Conditions

Malignant Brain Neoplasm

Malignant Solid Neoplasm

Multiple Sclerosis

Neuroendocrine Tumor

Prostate Carcinoma

Study ID

NCT06788886

Start date

Feb 5, 2025

Status verified date

Jun, 2026

Completion date

Jan 18, 2027

Anticipated

Primary completion date

Jan 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

147 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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)

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.

active comparator: Study 1 Group 2, Subgroup 3 (6 month walking routines)

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.

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)

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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Exercise Intervention

Participate in walking routines

Magnetic Resonance Imaging

Undergo MRI

Questionnaire Administration

Ancillary studies

Respiratory Therapy

Participate in breathing sessions

Primary outcome measure

  • Changes in respiratory function correlated with brain activity [ Time Frame: Baseline up to 6 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Paul H. Min, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-10.