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NCT Number: NCT07386444

Inspiratory Muscle Training for Breast Cancer Patients on Chemotherapy

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.

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Key information

Conditions

Early Stage Breast Carcinoma Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Dharini M. Bhammar, MBBS, PhD

CONTACT

[email protected]

614-366-9467

Dharini M. Bhammar, MBBS, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training

Behavioral

Training of respiratory muscles

Primary outcomes

  1. Maximum inspiratory pressure

    Time frame: Baseline to 8 weeks

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

Secondary outcomes

  1. Physical activity levels

    Time frame: Baseline to 8 weeks

    Number of steps/day averaged weekly.

  2. Modified Medical Research Council Dyspnea scale rating

    Time frame: Baseline to 8 weeks

    Patients will indicate the extent to which their dyspnea affects mobility using a one question 1-5 scale; higher scores indicate greater respiratory disability.

  3. Dyspnea 12 score

    Time frame: Baseline to 8 weeks

    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

  4. RAND-36 Quality of life

    Time frame: Baseline to 8 weeks

    8 subdomains will be scored 0-100 with higher scores reflecting better perceived quality of life.

  5. FACIT-F

    Time frame: Baseline to 8 weeks

    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.

Other outcomes

  1. Relative dose intensity of chemotherapy

    Time frame: At 8 weeks

    Will record the relative dose intensity of chemotherapy for each participant. The relative dose intensity will be averaged for analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Dharini Bhammar

CONTACT

[email protected]

614-366-9467

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Acronym: IMACT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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