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

Overview

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.

Interventions

• Behavioral Exercise and medical nutrition
  The study dietitian and exercise trainer will each conduct weekly counseling sessions via telephone or zoom throughout the course of chemotherapy (approximately 18 weeks) to assist the participants in achieving the diet and exercise study goals. Participants will be provided written informational material, exercise bands for strength training and a Fitbit to record activity. Participant goals are to: 1) participate in 150 min/week of moderate-intensity physical activity 2) participate in two we

Primary outcome measures

• Chemotherapy completion rate (relative dose intensity) [Time frame: Through end of first line chemotherapy, an average of 5 months]

Secondary outcome measures (12)

• Change in Skeletal muscle mass [Time frame: Through study completion, an average of 1 year]
• Change in Muscle Mass assessed using D3Creatine dilution method [Time frame: Through end of first line chemotherapy, an average of 5 months.]
• Change in Healthy Eating Index-2020 (24-hour recall) [Time frame: Through study completion, an average of 1 year]
• Change in Healthy Eating Index-2020 (FFQ) [Time frame: Through study completion, an average of 1 year]
• Change in Physical activity - objective measure [Time frame: Through study completion, an average of 1 year]
• Change in Physical activity - subjective measure [Time frame: Through study completion, an average of 1 year]
• Change in Neuropathy [Time frame: Through study completion, an average of 1 year]
• Change in Cognitive function [Time frame: Through study completion, an average of 1 year]
• Change in Arthralgia [Time frame: Through study completion, an average of 1 year]
• Change in GI disturbance [Time frame: Through study completion, an average of 1 year]
• Change in lower leg lymphedema [Time frame: Through study completion, an average of 1 year]
• Change in BMI [Time frame: Through study completion, an average of 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Yale University — New Haven
• University of Miami — Miami

Identifiers

NCT: NCT05761561 · 20211179 · U01CA271278

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗