Clinical trial NCT04997096: Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy
Official title: Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Ovarian Carcinoma
Ovarian Cancer Stage IV
Ovarian Cancer Stage III
Ovarian Cancer Stage 3
Endometrial Cancer
Endometrial Cancer Stage
Keywords: Ovarian Cancer
Ovarian Carcinoma
Ovarian Cancer Stage IV
Ovarian Cancer Stage III
Ovarian Cancer Stage 3
Endometrial Cancer
Aerobic Exercise
Strength Training
Cardiovascular training
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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:

* Aerobic and resistance exercise; virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom
* Attention control for 16 weeks, home-based stretching

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.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patients with stages III-IV ovarian or endometrial cancer
* Receiving first-line carboplatin and paclitaxel chemotherapy after surgery
* ≥18 years, children under the age of 18 will be excluded due to rarity of disease
* Physician's clearance to participate in moderate-vigorous intensity exercise
* Able to read, write, and understand English
* Ability to understand and the willingness to sign an informed consent document
* Willing to undergo two venous blood draws for the study

Exclusion Criteria:

* Pre-existing musculoskeletal, neurological, or cardiorespiratory conditions, as determined by the treating oncologist
* Participants with uncontrolled intercurrent illness, as determined by the treating oncologist
* Participants with psychiatric illness/social situations that would limit compliance with study requirements, as determined by the treating oncologist
* Participants who have received prior chemotherapy for cancer treatment (e.g. taxanes for breast cancer)

Primary outcomes:
measure: Proportion of patients completing the exercise intervention sessions.
timeFrame: 16 Weeks
measure: Enrollment Rate
timeFrame: 16 Weeks
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)-Lower Extremity Function
timeFrame: 16 Weeks
measure: Change in 6-minute walk distance
timeFrame: 16 weeks
measure: PROMIS- Physical function
timeFrame: 16 Weeks
measure: Number of Participants with Treatment Related Adverse Events
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christina Dieli-Conwright, PhD
role: PRINCIPAL_INVESTIGATOR
References: