Dyspnea, Early Stage Breast Carcinoma
Conditions
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.
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
BEHAVIORALInspiratory muscle training
Training of respiratory muscles
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to the intervention.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum inspiratory pressure | Baseline to 8 weeks | Measure of the strength of the inspiratory muscles. Units: cm H20 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity levels | Baseline to 8 weeks | Number of steps/day averaged weekly. |
| Modified Medical Research Council Dyspnea scale rating | 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. |
| Dyspnea 12 score | 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 |
| RAND-36 Quality of life | Baseline to 8 weeks | 8 subdomains will be scored 0-100 with higher scores reflecting better perceived quality of life. |
| FACIT-F | 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. |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
CONTACTDharini Bhammar
PRINCIPAL_INVESTIGATORDharini M Bhammar, MBBS, PhD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed