Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Cancer

NCT05787834 | Recruiting

• 2 other identifiers: I-3364822NCI-2023-01256
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial evaluates whether home-based respiratory muscle training is useful for minimizing side effects in patients undergoing treatment for cancer. Over-activation of the nervous system during breast cancer treatment can result in heart- and lung-related side effects which have the potential to reduce a patient's quality of life. Aerobic exercise can help prevent the development of these side effects. However, engaging in regular aerobic exercise may be difficult for breast cancer patients who are actively undergoing treatment. Respiratory muscle training (RMT) involves a series of breathing and other exercises that are performed to improve the function of the respiratory muscles through resistance and endurance training. Home-based RMT may represent a more feasible approach for reducing side effects in patients undergoing treatment for breast cancer.

Conditions

Breast Carcinoma; Head and Neck Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Proportion of patients who participate in the study

  Up to 12 weeks

• Proportion of patients who remain on study

  Up to 12 weeks

• Proportion of patients who perform >= 3 respiratory muscle training (RMT) sessions/week

  Overall compliance rates (compliance at all time points) will be estimated using 90% confidence intervals. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors (e.g., baseline age, performance status, self-reported history of exercise, breast cancer (BC) treatment received, treatment side-effects) using a generalized estimating equation (GEE) logistic regression model (auto-regressive covariance structure). Estimates of compliance rates will be obtained by time-point and tests about the appropriate contrasts of model estimates will be used to determine if there is a time trend.

  Up to 12 weeks

• Proportion of patients who perform > 70% of their RMT sessions

  Adherence rates (completion of \>= 70% of sessions) will be estimated using 90% confidence intervals. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors (e.g., baseline age, performance status, self-reported history of exercise, BC treatment received, treatment side-effects) using a GEE logistic regression model (auto-regressive covariance structure). Estimates of compliance rates will be obtained by time-point and tests about the appropriate contrasts of model estimates will be used to determine if there is a time trend.

  Up to 12 weeks

Secondary Outcomes (10)

• Change in Functional Capacity

  At baseline, 6 weeks, and 12 weeks

• Change in Lower body strength

  At baseline, 6 weeks, and 12 weeks

• Assess Dyspnea

  At baseline, 6 weeks, and 12 weeks

• Assess Fatigue

  At baseline, 6 weeks, and 12 weeks

• Change in Quality of life

  At baseline, 6 weeks, and 12 weeks

Study Arms (2)

Group I (low resistance RMT Group)

ACTIVE COMPARATOR

Patients receive usual care for 12 weeks on study and a Respiratory Muscle training Device with small breathing resistance

Other: Best Practice; Other: Medical Device Usage and Evaluation; Procedure: Respiratory Muscle Training; Other: Survey Administration

Group II (Moderate to highter resistance RMT)

EXPERIMENTAL

Patients undergo RMT using a respiratory muscle training device with moderate to higher breathing resistance for 12 weeks on study.

Other: Medical Device Usage and Evaluation; Procedure: Respiratory Muscle Training; Other: Survey Administration

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Group I (low resistance RMT Group)

Medical Device Usage and Evaluation OTHER

Wear accelerometer

Group I (low resistance RMT Group); Group II (Moderate to highter resistance RMT)

Respiratory Muscle Training PROCEDURE

Undergo RMT

Also known as: RMT

Group I (low resistance RMT Group); Group II (Moderate to highter resistance RMT)

Survey Administration OTHER

Ancillary studies

Group I (low resistance RMT Group); Group II (Moderate to highter resistance RMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented breast cancer and scheduled to receive adjuvant or neoadjuvant chemotherapy
• Age \>= 21 years old
• Diagnosed with solid tumor (e.g., head and neck, thoracic, or breast cancer)
• Scheduled to receive at least one dose of chemotherapy or immunotherapy or radiation
• Treated at Roswell Park Comprehensive Cancer Center

You may not qualify if:

• Presence of oral mucosal disease including oral mucositis, or oral candidiasis detected at baseline
• Have uncontrolled intercurrent illness including, but not limited to, ongoing or active respiratory infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness/social situations that would limit compliance with study requirements
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Head and Neck Neoplasms; Lung Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Breathing Exercises

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Ellis Levine, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ASK RPCI

CONTACT

1-877-275-7724; askrpci@roswellpark.org

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: February 23, 2023
• First Posted: March 28, 2023
• Study Start: October 16, 2023
• Primary Completion (Estimated): October 16, 2028
• Study Completion (Estimated): October 16, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

US (1)