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

The Ohio State University

Status: Enrolling

Conditions: Dyspnea; Early Stage Breast Carcinoma

Treatments: Behavioral: Inspiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT07386444

NCI-2026-00179 (Registry Identifier)

OSU-25238

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Arm 1 (low-intensity IMT)

Active Comparator group

Description:

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

Treatment:

Behavioral: Inspiratory muscle training

Arm 2 (high-intensity IMT)

Experimental group

Description:

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

Treatment:

Behavioral: Inspiratory muscle training