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NCT05761561 | RECRUITING | Ovarian Cancer

Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer
Sponsor:

Yale University

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.

Condition or disease

Ovarian Cancer

Intervention/treatment

Exercise and medical nutrition

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : SINGLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Trial of Exercise and Lifestyle (TEAL) for Women With Ovarian and Endometrial Cancer
Actual Study Start Date : 2023-04-19
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2027-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer

Location Details

NCT05761561

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Locations

RECRUITING

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06511

RECRUITING

United States, Florida

University of Miami

Miami, florida, United States, 33136