Inspiratory Muscle Training for Breast Cancer Patients on Chemotherapy

NCT07386444 | Recruiting

• 2 other identifiers: OSU-25238NCI-2026-00179
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies whether breathing exercises for the muscles that help with breathing air in, inspiratory muscle training (IMT), works to improve breathing muscle strength, shortness of breath, and physical activity levels in women who are receiving chemotherapy for early-stage breast cancer (BC). Cancer and/or treatments for BC can directly result in muscle wasting that involves breathing muscles, skeletal muscles or heart muscles. Pain, weakness, shortness of breath, and side effects of cancer treatment may lead to lower physical activity levels. IMT involves breathing exercises using a small hand-held device. The device makes it a little harder to breathe in, which may help strengthen breathing muscles. IMT may be an effective way to improve breathing muscle strength, shortness of breath, and physical activity levels in women who are receiving chemotherapy for early-stage BC.

Conditions

Early Stage Breast Carcinoma; Dyspnea

Outcome Measures

Primary Outcomes (1)

• Maximum inspiratory pressure

  Measure of the strength of the inspiratory muscles. Units: cm H20

  Baseline to 8 weeks

Secondary Outcomes (5)

• Physical activity levels

  Baseline to 8 weeks

• Modified Medical Research Council Dyspnea scale rating

  Baseline to 8 weeks

• Dyspnea 12 score

  Baseline to 8 weeks

• RAND-36 Quality of life

  Baseline to 8 weeks

• FACIT-F

  Baseline to 8 weeks

Other Outcomes (1)

• Relative dose intensity of chemotherapy

  At 8 weeks

Study Arms (2)

Arm 1 (low-intensity IMT)

ACTIVE COMPARATOR

Patients complete three sets of fifteen repetitions per session of low-intensity IMT over 15-20 minutes four days a week for 8 weeks.

Behavioral: Inspiratory muscle training

Arm 2 (high-intensity IMT)

EXPERIMENTAL

Patients complete three sets of fifteen repetitions per session of high-intensity IMT over 15-20 minutes four days a week for 8 weeks.

Behavioral: Inspiratory muscle training

Interventions

Inspiratory muscle training BEHAVIORAL

Training of respiratory muscles

Arm 1 (low-intensity IMT); Arm 2 (high-intensity IMT)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Within 3 weeks of starting chemotherapy for an early-stage breast cancer diagnosis
• Able to exercise independently without needing support
• Ability to read, speak, understand English

You may not qualify if:

• Metastatic breast cancer
• Unwilling or unable to follow protocol requirements
• Any significant health condition which in the investigator's opinion increases the risks of participation or makes the participant unsuitable for the study

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dharini M Bhammar, MBBS, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Dharini Bhammar

CONTACT

614-366-9467; dharini.bhammar@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available after data collection is complete for up to 3 years.
• Access Criteria: Deidentified data will be made available on request following approved data use agreements between institutions.

Locations

US (1)