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

NCT06788886 | Recruiting

• 2 other identifiers: 24-000979NCI-2025-00205
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in respiratory function correlated with brain activity

  Assessed using advanced imaging techniques (such as MRI) and physiological analyses. The approach to data analysis will involve a detailed examination of the MRI data collected from each participant. Respiratory data will be correlated with neuroimaging findings to provide a comprehensive view of how respiratory patterns may influence brain activity.

  Baseline up to 6 months

Secondary Outcomes (10)

• Change in QOL - PHQ-9

  Baseline up to 6 months

• Change in QOL - GAD-7

  Baseline up to 6 months

• Change in QOL - Linear Analog Self Assessment

  Baseline up to 6 months

• Adherence to the breathing protocol for the intention group

  Up to 6 months

• Change in sleep quality - PSQI

  Baseline up to 6 months

Study Arms (7)

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

EXPERIMENTAL

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.

Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Respiratory Therapy

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

EXPERIMENTAL

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.

Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Respiratory Therapy

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

ACTIVE COMPARATOR

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.

Other: Exercise Intervention; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

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

EXPERIMENTAL

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.

Other: Exercise Intervention; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Respiratory Therapy

Study 2 (4 month breathing sessions)

EXPERIMENTAL

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.

Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Respiratory Therapy

Study 3 Subgroup 5 (6 month breathing sessions)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Respiratory Therapy

Study 3 Subgroup 6 (4 months breathing sessions)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Respiratory Therapy

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Study 3 Subgroup 5 (6 month breathing sessions); Study 3 Subgroup 6 (4 months breathing sessions)

Exercise Intervention OTHER

Participate in walking routines

Study 1 Group 2, Subgroup 3 (6 month walking routines); Study 1 Group 2, Subgroup 4 (walking + breathing)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Study 1 Group 1, Subgroup 1 (6 month breathing sessions); Study 1 Group 1, Subgroup 2 (4 month breathing sessions); Study 1 Group 2, Subgroup 3 (6 month walking routines); Study 1 Group 2, Subgroup 4 (walking + breathing); Study 2 (4 month breathing sessions); Study 3 Subgroup 5 (6 month breathing sessions); Study 3 Subgroup 6 (4 months breathing sessions)

Questionnaire Administration OTHER

Ancillary studies

Study 1 Group 1, Subgroup 1 (6 month breathing sessions); Study 1 Group 1, Subgroup 2 (4 month breathing sessions); Study 1 Group 2, Subgroup 3 (6 month walking routines); Study 1 Group 2, Subgroup 4 (walking + breathing); Study 2 (4 month breathing sessions); Study 3 Subgroup 5 (6 month breathing sessions); Study 3 Subgroup 6 (4 months breathing sessions)

Respiratory Therapy PROCEDURE

Participate in breathing sessions

Study 1 Group 1, Subgroup 1 (6 month breathing sessions); Study 1 Group 1, Subgroup 2 (4 month breathing sessions); Study 1 Group 2, Subgroup 4 (walking + breathing); Study 2 (4 month breathing sessions); Study 3 Subgroup 5 (6 month breathing sessions); Study 3 Subgroup 6 (4 months breathing sessions)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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: 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Neoplasms; Multiple Sclerosis; Neuroendocrine Tumors; Prostatic Neoplasms

Interventions

Specimen Handling; Magnetic Resonance Spectroscopy; Respiratory Therapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Therapeutics

Study Officials

• Paul H. Min, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: February 5, 2025
• Primary Completion (Estimated): January 18, 2027
• Study Completion (Estimated): January 18, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (1)