Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Location status: Recruiting
Location contact
Christina Dieli-Conwright, PhD
PRINCIPAL_INVESTIGATOR
Christina Dieli-Conwright, PhD, MPH
CONTACT
Mary Norris, MS
CONTACT
NCT Number: NCT04997096
The purpose of this research is to determine whether a 16-week virtually supervised aerobic and resistance exercise program is feasible in patients receiving first-line chemotherapy after surgery for ovarian or endometrial cancer and if it will improve lower extremity function (function of the legs), lessen chemotherapy-induced peripheral neuropathy (CIPN; numbness or tingling in the hands or feet), and if there is any effect on inflammatory blood markers (the level of a certain marker in the blood that is associated with inflammation; redness and swelling).
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
Location status: Recruiting
Christina Dieli-Conwright, PhD
PRINCIPAL_INVESTIGATOR
Christina Dieli-Conwright, PhD, MPH
CONTACT
Mary Norris, MS
CONTACT
This research study is a randomized controlled trial that will compare an exercise group to a control group on lower extremity function, CIPN, and inflammatory markers in ovarian or endometrial cancer patients undergoing first-line chemotherapy after surgery.
The names of the study interventions involved in this study are/is:
The research study procedures include: screening for eligibility and study interventions including evaluations and follow up visits.
It is expected that about 30 people will take part in this research study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
16-week, virtually supervised, technology-based, aerobic and resistance exercise program performed 3 days per week which starts at least 4 weeks after surgery
Home-based stretching program consisting of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. Participants will be shown how to use the booklet and instructed on how to complete the stretching exercises by an exercise trainer.
Time frame: 16 Weeks
The feasibility of the 16-week exercise intervention is defined as the proportion of patients completing the exercise intervention sessions. The analysis population will be the eligible patients who are assigned to the intervention group (N=20). The investigators will estimate the proportion and corresponding 95% exact confidence interval (CI).99 The Investigators expect that the proportion is 70% or higher
Time frame: 16 Weeks
The enrollment rate is defined as the proportion of patients who participate in the study among those patients who are approached for the enrollment.
Time frame: 16 Weeks
Short Physical Performance Battery (SPPB), an objective measure of lower-extremity function based on three timed tests of standing balance, walking speed, and chair stand tests, which in older adults is predictive of disability, nursing home admission, and all-cause mortality
Time frame: 16 weeks
Aerobic fitness will be assessed by the 6-minute walk test (6MWT). The 6MWT has been administered in cancer survivors and has a reliability coefficient of 0.93 when tested in cancer survivors. Participants will be instructed to walk as quickly as possible without running on an indoor pre-measured walkway for 6 minutes
Time frame: 16 Weeks
Physical function will be assessed using the Patient Reported Outcome Measure Information System (PROMIS) Physical Function-10 scale.
Time frame: 16 Weeks
NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Contact information is provided by the study sponsor or research team.
Dana-Farber Cancer Institute
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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