Clinical trial NCT05761561: Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer
Official title: Trial of Exercise and Lifestyle (TEAL) for Women With Ovarian and Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Miami
name: National Cancer Institute (NCI)
First posted: 2023-03-09
Enrollment: 200
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: An anticipated 200 women with newly diagnosed ovarian and endometrial cancer scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital Network at Yale Cancer Center (YCC) and Sylvester Comprehensive Cancer Center (SCCC) at University of Miami.

Participants will be randomized to an exercise and medical nutrition intervention arm with weekly counseling sessions throughout chemotherapy, or a control arm.

Study assessments will be conducted at baseline, post-chemotherapy/end of intervention and at 1-year post diagnosis. Women who are prescribed neoadjuvant therapy will have additional assessments prior to surgery.

Data required to calculate the primary endpoint (relative dose intensity of chemotherapy) will be abstracted from the medical record directly following each chemotherapy session.

Detailed description: 200 women with newly diagnosed ovarian or endometrial cancer scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital at Yale Cancer Center (YCC) and Sylvester Comprehensive Cancer Center (SCCC) at University of Miami. If women are interested and eligible, the study team will obtain consent and collect baseline data. Participants will be randomized to an exercise and medical nutrition intervention (18 weeks dependent on length of chemotherapy) or usual care throughout therapy. After the standard 6 cycles of chemotherapy (\~18 weeks), a post-chemotherapy/end of intervention visit will be conducted. Follow-up assessments will be at standard of care visits (12-months post-diagnosis). Data required to calculate the primary endpoint (relative dose intensity of chemotherapy) will be abstracted from the medical record directly following each chemotherapy session.

Eligibility criteria: Inclusion Criteria:

* have a diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, stage I-IV OR have a diagnosis of advanced or metastatic endometrial carcinoma (including carcinosarcoma) AND their treatment regimen includes carboplatin and taxane (or equivalent)
* be scheduled to receive at least 6 cycles of neoadjuvant or adjuvant chemotherapy
* be physically able to walk without a walking aid (e.g. cane or walker)
* be able to complete forms, understand instructions and read intervention book in English or Spanish
* agree to be randomly assigned to either group
* have clearance from oncologist to participate
* be ≥ 18 years of age

Exclusion Criteria:

* having already completed a 2nd cycle of chemotherapy
* already practicing dietary (\>7 servings of fruits and vegetables per day) OR physical activity guidelines (≥150 min per week of moderate to vigorous exercise and resistance training two times per week) since diagnosis
* pregnancy or intention to become pregnant
* recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction \<40%
* presence of dementia or major psychiatric disease
* in active treatment including target or biologic therapies for any other cancer (excluding hormone therapy treatments)
* receiving external beam radiation

Primary outcomes:
measure: Chemotherapy completion rate (relative dose intensity)
timeFrame: Through end of first line chemotherapy, an average of 5 months
Secondary outcomes:
measure: Change in Skeletal muscle mass
timeFrame: Through study completion, an average of 1 year
measure: Change in Muscle Mass assessed using D3Creatine dilution method
timeFrame: Through end of first line chemotherapy, an average of 5 months.
measure: Change in Healthy Eating Index-2020 (24-hour recall)
timeFrame: Through study completion, an average of 1 year
measure: Change in Healthy Eating Index-2020 (FFQ)
timeFrame: Through study completion, an average of 1 year
measure: Change in Physical activity - objective measure
timeFrame: Through study completion, an average of 1 year
measure: Change in Physical activity - subjective measure
timeFrame: Through study completion, an average of 1 year
measure: Change in Neuropathy
timeFrame: Through study completion, an average of 1 year
measure: Change in Cognitive function
timeFrame: Through study completion, an average of 1 year
measure: Change in Arthralgia
timeFrame: Through study completion, an average of 1 year
measure: Change in GI disturbance
timeFrame: Through study completion, an average of 1 year
measure: Change in lower leg lymphedema
timeFrame: Through study completion, an average of 1 year
measure: Change in BMI
timeFrame: Through study completion, an average of 1 year
measure: Change in waist circumference
timeFrame: Through study completion, an average of 1 year
measure: Change in Skin Carotenoids
timeFrame: Through study completion, an average of 1 year
measure: Change in Fitness
timeFrame: Through study completion, an average of 1 year
measure: Change in grip strength
timeFrame: Through study completion, an average of 1 year
measure: Change in blood biomarkers
timeFrame: Through study completion, an average of 1 year
measure: Change in financial toxicity
timeFrame: Through study completion, an average of 1 year
measure: Change in level of function and ability to perform specific tasks
timeFrame: Through study completion, an average of 1 year
measure: Change in Social Support
timeFrame: Through study completion, an average of 1 year
measure: Change in Social Activity
timeFrame: Through study completion, an average of 1 year
measure: Change in Quality of life (SF-36)
timeFrame: Through study completion, an average of 1 year
measure: Change in Sleep Quality
timeFrame: Through study completion, an average of 1 year
measure: Change in Fatigue
timeFrame: Through study completion, an average of 1 year
measure: Change in symptoms of chemotherapy assessed using the Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: Through end of chemotherapy, an average of 5 months.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
References: