Inspiratory Muscle Training for Breast Cancer Patients on Chemotherapy (IMACT)

Effects of Inspiratory Muscle Training Among Breast Cancer Patients Undergoing Active Treatment (IMACT)

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.

Study Overview

• Status: Recruiting
• Conditions: Dyspnea; Early Stage Breast Carcinoma
• Intervention / Treatment: Behavioral: Inspiratory muscle training

Detailed Description

PRIMARY OBJECTIVE: To investigate the effects of 8 weeks of IMT on inspiratory muscle strength, exertional dyspnea, and physical activity levels among women undergoing chemotherapy for BC.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients complete three sets of fifteen repetitions per session of low-intensity IMT over 15-20 minutes four days a week for 8 weeks.

ARM 2: Patients complete three sets of fifteen repetitions per session of high-intensity IMT over 15-20 minutes four days a week for 8 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu
• Study Contact Backup: Name: Dharini Bhammar; Phone Number: 614-366-9467; Email: dharini.bhammar@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Dharini M. Bhammar, MBBS, PhD; Phone Number: 614-366-9467; Email: Dharini.Bhammar@osumc.edu
      • Principal Investigator: Dharini M. Bhammar, MBBS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1 (low-intensity IMT); 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; Training of respiratory muscles
Experimental: Arm 2 (high-intensity IMT); 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; Training of respiratory muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum inspiratory pressure	Measure of the strength of the inspiratory muscles. Units: cm H20	Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity levels	Number of steps/day averaged weekly.	Baseline to 8 weeks
Modified Medical Research Council Dyspnea scale rating	Patients will indicate the extent to which their dyspnea affects mobility using a one question 1-5 scale; higher scores indicate greater respiratory disability.	Baseline to 8 weeks
Dyspnea 12 score	Questionnaire consists of 12 descriptor items such as "I feel short of breath" and "my breathing is uncomfortable" with each item rated on a scale of none (0), mild (1), moderate (2), or severe (3). Individual items are summed to generate a total score (0 to 36), with a higher score indicating worse dyspnea	Baseline to 8 weeks
RAND-36 Quality of life	8 subdomains will be scored 0-100 with higher scores reflecting better perceived quality of life.	Baseline to 8 weeks
FACIT-F	Version 4 is a 40-item measure that will be used to assess self-reported fatigue and its impact on daily activities and function over the past 7 days. It is a 5-point Likert-type scale with five subdomains including physical well-being, social/family well-being, emotional well-being, functional well-being, and fatigue yielding a total score from 0-52.	Baseline to 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative dose intensity of chemotherapy	Will record the relative dose intensity of chemotherapy for each participant. The relative dose intensity will be averaged for analysis.	At 8 weeks

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Dharini M Bhammar, MBBS, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dyspnea
• Other Study ID Numbers: OSU-25238; NCI-2026-00179 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be freely available if requested. The privacy and rights of the participants will be protected.
• IPD Sharing Time Frame: Data will become available after data collection is complete for up to 3 years.
• IPD Sharing Access Criteria: Deidentified data will be made available on request following approved data use agreements between institutions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No