Recruiting

Inspiratory Muscle Training

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07386444

Conditions

Early Stage Breast Carcinoma

Dyspnea

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inspiratory muscle training

Study Details

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

Study ID

NCT07386444

Start date

Feb 16, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

58 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Inspiratory muscle training

Training of respiratory muscles

Primary outcome measure

  • Maximum inspiratory pressure [ Time Frame: Baseline to 8 weeks ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Dharini M. Bhammar, MBBS, PhD

614-366-9467Dharini.Bhammar@osumc.edu

Principal Investigator:

Dharini M. Bhammar, MBBS, PhD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-04-06.