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Recruiting NCT07386444

Inspiratory Muscle Training for Breast Cancer Patients on Chemotherapy

No phase Interventional Early Stage Breast Carcinoma Dyspnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inspiratory muscle training.
Who it may be relevant to
Registry conditions: Early Stage Breast Carcinoma, Dyspnea. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Behavioral Inspiratory muscle training
    Training of respiratory muscles

Primary outcome measures

  • Maximum inspiratory pressure [Time frame: Baseline to 8 weeks]
Secondary outcome measures (5)
  • Physical activity levels [Time frame: Baseline to 8 weeks]
  • Modified Medical Research Council Dyspnea scale rating [Time frame: Baseline to 8 weeks]
  • Dyspnea 12 score [Time frame: Baseline to 8 weeks]
  • RAND-36 Quality of life [Time frame: Baseline to 8 weeks]
  • FACIT-F [Time frame: Baseline to 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT07386444 · OSU-25238 · NCI-2026-00179

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗