Inspiratory Muscle Training for Breast Cancer Patients on Chemotherapy

ConditionsEarly Stage Breast Carcinoma Dyspnea

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

Inspiratory muscle training
Behavioral
Training of respiratory muscles

Treatment groups

58 Participants

are divided into 2 treatment groups

Group A: Arm 1 (low-intensity IMT)Active comparator 1 intervention

Group B: Arm 2 (high-intensity IMT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Maximum inspiratory pressure

Measure of the strength of the inspiratory muscles. Units: cm H20

Time frame

Baseline to 8 weeks

Secondary outcomes

Physical activity levels

Number of steps/day averaged weekly.

Time frame

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.

Time frame

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

Time frame

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.

Time frame

Baseline to 8 weeks

Other outcomes

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.

Time frame

At 8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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