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Trial Title:
Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Breast Cancer
NCT ID:
NCT05787834
Condition:
Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive usual care
Arm group label:
Group I (low resistance RMT Group)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear accelerometer
Arm group label:
Group I (low resistance RMT Group)
Arm group label:
Group II (Moderate to highter resistance RMT)
Intervention type:
Procedure
Intervention name:
Respiratory Muscle Training
Description:
Undergo RMT
Arm group label:
Group I (low resistance RMT Group)
Arm group label:
Group II (Moderate to highter resistance RMT)
Other name:
RMT
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Group I (low resistance RMT Group)
Arm group label:
Group II (Moderate to highter resistance RMT)
Summary:
This clinical trial evaluates whether home-based respiratory muscle training is useful
for minimizing side effects in patients undergoing treatment for breast 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.
Detailed description:
PRIMARY OBJECTIVE:
I. To assess the feasibility of delivering a 12-week RMT program during adjuvant and
neoadjuvant chemotherapy used to treat breast cancer.
SECONDARY OBJECTIVES:
I. To determine how cardiac autonomic regulation, cardiorespiratory fitness, exercise
performance, and quality-of-life (QoL) are affected by RMT during breast cancer
treatment.
II. To assess how RMT affects patient reported symptoms linked to sympathetic
overactivation such as stress, fatigue, dyspnea, when performed during chemotherapy.
EXPLORATORY OBJECTIVE:
I. To determine if RMT reduces circulating biomarkers of autonomic dysfunction,
inflammation, and cardiac injury in breast cancer patients undergoing treatment.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: patients receive lower resistance RMT using a respiratory muscle training device
for 12 weeks.
GROUP II: Patients undergo higher resistance RMT using a respiratory muscle training
device for 12 weeks on study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Documented breast cancer and scheduled to receive adjuvant or neoadjuvant
chemotherapy
- Age >= 18 years old
- Cognitively capable of following direction and performing the intervention
- Able to speak, read and comprehend English language
- Understand the investigational nature of this study and sign an Independent Ethics
Committee/Institutional Review Board approved written informed consent form prior to
receiving any study related procedure
Exclusion Criteria:
- Have uncontrolled intercurrent illness including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, heart failure or psychiatric illness/social situations that
would limit compliance with study requirements
- Prior radiation to the left chest wall
- Patients with medical frailty (clinical discretion)
- Are pregnant or nursing
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the participant an
unsuitable candidate to receive study intervention
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shipra Gandhi, MD
Phone:
716-845-1486
Email:
Shipra.Gandhi@roswellpark.org
Investigator:
Last name:
Shipra Gandhi, MD
Email:
Principal Investigator
Start date:
October 16, 2023
Completion date:
October 16, 2029
Lead sponsor:
Agency:
Roswell Park Cancer Institute
Agency class:
Other
Source:
Roswell Park Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05787834
