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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-00179 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (low-intensity IMT) | Active Comparator | 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 (high-intensity IMT) | Experimental | Patients complete three sets of fifteen repetitions per session of high-intensity IMT over 15-20 minutes four days a week for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory muscle training | Behavioral | Training of respiratory muscles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum inspiratory pressure | Measure of the strength of the inspiratory muscles. Units: cm H20 | Baseline to 8 weeks |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu | |
| Dharini Bhammar | Contact | 614-366-9467 | dharini.bhammar@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dharini M Bhammar, MBBS, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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Deidentified data will be freely available if requested. The privacy and rights of the participants will be protected.
Data will become available after data collection is complete for up to 3 years.
Deidentified data will be made available on request following approved data use agreements between institutions.
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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Participants will be blinded to the intervention.
| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |