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Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Cancer

ConditionsBreast CarcinomaHead and Neck CancerLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorRoswell Park Cancer Institute

About this trial

This clinical trial evaluates whether home-based respiratory muscle training is useful for minimizing side effects in patients undergoing treatment for cancer. Over-activation of the nervous system during breast cancer treatment can result in heart- and lung-related side effects which have the potential to reduce a patient's quality of life. Aerobic exercise can help prevent the development of these side effects. However, engaging in regular aerobic exercise may be difficult for breast cancer patients who are actively undergoing treatment. Respiratory muscle training (RMT) involves a series of breathing and other exercises that are performed to improve the function of the respiratory muscles through resistance and endurance training. Home-based RMT may represent a more feasible approach for reducing side effects in patients undergoing treatment for breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide written informed consent

Age >= 21 years old

Diagnosed with solid tumor (e.g., head and neck, thoracic, or breast cancer)

Scheduled to receive at least one dose of chemotherapy or immunotherapy or radiation

Disqualifiers

Presence of oral mucosal disease including oral mucositis, or oral candidiasis detected at baseline

Have uncontrolled intercurrent illness including, but not limited to, ongoing or active respiratory infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness/social situations that would limit compliance with study requirements

Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Trial design

Design model

Parallel

Treatments tested in this trial

  • Best Practice

    Other intervention

    Receive usual care

  • Medical Device Usage and Evaluation

    Other intervention

    Wear accelerometer

  • Respiratory Muscle Training

    Procedure/Surgery

    Undergo RMT

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Group I (low resistance RMT Group)Active comparator 4 interventions
Group B: Group II (Moderate to highter resistance RMT)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients who participate in the study

Time frame
Up to 12 weeks
2

Proportion of patients who remain on study

Time frame
Up to 12 weeks
3

Proportion of patients who perform >= 3 respiratory muscle training (RMT) sessions/week

Overall compliance rates (compliance at all time points) will be estimated using 90% confidence intervals. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors (e.g., baseline age, performance status, self-reported history of exercise, breast cancer (BC) treatment received, treatment side-effects) using a generalized estimating equation (GEE) logistic regression model (auto-regressive covariance structure). Estimates of compliance rates will be obtained by time-point and tests about the appropriate contrasts of model estimates will be used to determine if there is a time trend.

Time frame
Up to 12 weeks
4

Proportion of patients who perform > 70% of their RMT sessions

Adherence rates (completion of \>= 70% of sessions) will be estimated using 90% confidence intervals. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors (e.g., baseline age, performance status, self-reported history of exercise, BC treatment received, treatment side-effects) using a GEE logistic regression model (auto-regressive covariance structure). Estimates of compliance rates will be obtained by time-point and tests about the appropriate contrasts of model estimates will be used to determine if there is a time trend.

Time frame
Up to 12 weeks

Secondary outcomes

1

Change in Functional Capacity

Six minute walking test is a functional test of sub-maximum cardiorespiratory capacity.

Time frame
At baseline, 6 weeks, and 12 weeks
2

Change in Lower body strength

The Short Physical Performance Battery - PPB is comprised of 3 tasks: a hierarchial standing balance test (side by side, semi-tandem and tandem), 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 Points (p) and then summarized into a total score of 0-12 p, where 12 p represents the highest performance.

Time frame
At baseline, 6 weeks, and 12 weeks
3

Assess Dyspnea

Dyspnea will be measured by the Dyspnea-12 questionnaire which contains 12 items on a scale of 0(none), mild (1) and Severe (3) and evaluates the physical and affective dimensions of dyspnea. Higher scores represent greater severity.

Time frame
At baseline, 6 weeks, and 12 weeks
4

Assess Fatigue

Fatigue will be measured using the Brief Fatigue Inventory (BFI). Each item is scored 1 (no fatigue) to 10 (as bad as you can imagine) to assess the severity of fatigue and its impact on daily functioning. A global fatigue score is obtained by averaging all the items (1-3: mild, 4-7: moderate, 8-10: severe)

Time frame
At baseline, 6 weeks, and 12 weeks

Other outcomes

Sponsors and contacts

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

Roswell Park Cancer Institute

Lead sponsor

Source ClinicalTrials.gov
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