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Malignant Brain NeoplasmNCT06788886

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

A study testing Biospecimen Collection, Exercise Intervention and Magnetic Resonance Imaging in people with Malignant Brain Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
What is being tested?
Biospecimen Collection, Exercise Intervention and Magnetic Resonance Imaging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
1 siteUnited States
Study dates
5 Feb 2025to 18 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Paul H. Min, PhD

    Recruiting

Other trials in United States

About this study

Official title: Enhancing Brain and Mental Health Through Respiratory Training: Clinical Applications in Cancer and Neurodegenerative Disease Care for Patients and Caregivers (Breathing Study)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Biospecimen Collection, Exercise Intervention, Magnetic Resonance Imaging, Questionnaire Administration, Respiratory Therapy
Medical subject headings
Brain Neoplasms, Multiple Sclerosis, Neuroendocrine Tumors, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Exercise InterventionOther

    Participate in walking routines

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Questionnaire AdministrationOther

    Ancillary studies

  • Respiratory TherapyProcedure or surgery

    Participate in breathing sessions

Study groups in NCT06788886
Study groupRoleWhat they receive
Study 1 Group 1, Subgroup 1 (6 month breathing sessions)ExperimentalParticipants 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.
Receives: Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Respiratory Therapy
Study 1 Group 1, Subgroup 2 (4 month breathing sessions)ExperimentalParticipants 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.
Receives: Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Respiratory Therapy
Study 1 Group 2, Subgroup 3 (6 month walking routines)Active comparatorParticipants 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.
Receives: Other: Exercise Intervention; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration
Study 1 Group 2, Subgroup 4 (walking + breathing)ExperimentalParticipants 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.
Receives: Other: Exercise Intervention; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Respiratory Therapy
Study 2 (4 month breathing sessions)ExperimentalCancer 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.
Receives: Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Respiratory Therapy
Study 3 Subgroup 5 (6 month breathing sessions)ExperimentalMS 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.
Receives: Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Respiratory Therapy
Study 3 Subgroup 6 (4 months breathing sessions)ExperimentalMS 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.
Receives: Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Respiratory Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline up to 6 months

Secondary outcomes (10)

  1. Change in QOL - PHQ-9

    Assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 questions related to problems experienced over the past 2 weeks. Questions are answered on a scale of 0-3 where 0=Not at all; 1=several days; 2=more than half the days, and 3=nearly every day.

    Measured: Baseline up to 6 months

  2. Change in QOL - GAD-7

    Assessed using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 consists of 7 questions related to problems experienced over the past 2 weeks. Questions are answered on a scale of 0-3 where 0=Not at all; 1=several days; 2=more than half the days, and 3=nearly every day.

    Measured: Baseline up to 6 months

  3. Change in QOL - Linear Analog Self Assessment

    Assessed using the Linear Analog Self Assessment, which consists of 5 questions related to feeling related to well being experienced over the past week. Questions are answered on a scale ranging from 0-10 where 0=as bad as it can be and 10=as good as it can be.

    Measured: Baseline up to 6 months

  4. Adherence to the breathing protocol for the intention group

    Measured: Up to 6 months

  5. Change in sleep quality - PSQI

    Assessed using the Pittsburgh Sleep Quality Index (PSQI), which consists of questions related to sleep habits during the past month. Questions begin with sleep habits (general time going to bed, how long to fall asleep, general rising time, etc.). These are followed by a list of items answered on scale of 0-3 where 0=not during the past month; 1=less than once a week; 2=once or twice a week ;and 3=three or more times a week. Higher scores indicate worse sleep quality.

    Measured: Baseline up to 6 months

  6. Change in sleepiness - ESS

    Assessed using the Epworth Sleepiness Scale (ESSI), which consists of questions related to sleep habits during the past month. The survey consists of a list of eight situations in which the respondents rate their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. The scale estimates whether participants are experiencing excessive sleepiness, which higher scores indicating a higher level of sleepiness..

    Measured: Baseline up to 6 months

  7. Change in fatigue - MFIS

    Assessed using the Modified Fatigue Impact Scale (MFIS), which consists of 21 questions related to the effects of fatigue over the past 4 weeks. Questions are answered on a scale of 0-4 where 0=never; 1=rarely; 2=sometimes; 3=often; and 4=almost always.

    Measured: Baseline up to 6 months

  8. Change in caregiver strain - CSI

    Assessed using the Caregiver Strain Index (CSI), a list of 13 "things that other people have found to be difficult." Caregivers respond with yes or no to indicate whether each item applies to them.

    Measured: Baseline up to 6 months

  9. Change in resilience - BRS

    Assessed using the Brief Resilience Scale (BRS), which consists of 6 items answered on a scale of 1-5 where 1=strongly disagree; 2=disagree; 3=neutral; 4=agree, and 5=strongly agree (or the reverse, i.e. 5=strongly disagree and 1=strongly agree). Higher scores generally indicate stronger resilience.

    Measured: Baseline up to 6 months

  10. Change in ability to implement health-promoting behaviors - SRAHP

    Assessed using the Self Rated Abilities for Health Practices Scale (SRAHP), a 28-item, 5-point scale. SRAHP contains four subscales: Exercise, Nutrition, Responsible Health Practice, and Psychological Well Being. Each subscale has seven items. Respondents are asked to rate the extent to which they are able to perform health practices related to these four domains. Responses are on a 5-point scale where 0=not at all; 1=a little; 2=somewhat; 3=mostly; and 4=completely. Higher scores indicate greater self-efficacy for health practices.

    Measured: Baseline up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2025
  2. Study start5 Feb 2025
  3. Primary completion18 Jan 2027 (estimated)
  4. Study completion18 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
147 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06788886
Sponsor's protocol ID
24-000979
Other IDs
NCI-2025-00205, 24-000979
Status last verified
Jun 2026
First submitted
17 Jan 2025
Last updated
10 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Biospecimen Collection, Exercise Intervention and Magnetic Resonance Imaging in people with Malignant Brain Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in respiratory function correlated with brain activity (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06788886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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