Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    16-week, virtually supervised, technology-based, aerobic and resistance exercise program performed 3 days per week which starts at least 4 weeks after surgery

  • Attention Control

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: ExerciseExperimental treatment 1 intervention
Group B: Attention ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients completing the exercise intervention sessions.

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
2

Enrollment Rate

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

Secondary outcomes

1

Short Physical Performance Battery (SPPB)-Lower Extremity Function

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
2

Change in 6-minute walk distance

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
3

PROMIS- Physical function

Physical function will be assessed using the Patient Reported Outcome Measure Information System (PROMIS) Physical Function-10 scale.

Time frame
16 Weeks
4

Number of Participants with Treatment Related Adverse Events

NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Time frame
16 Weeks

Other outcomes

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