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

Description

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.

Conditions

Ovarian Cancer

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Study Overview

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Study Details

Study 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.

Trial of Exercise and Lifestyle (TEAL) for Women With Ovarian and Endometrial Cancer

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

Condition
Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University, New Haven, Connecticut, United States, 06511

Miami

University of Miami, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Study Record Dates

2027-06