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New treatment option for Ovarian Cancer
Official title Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer
ClinicalTrials.gov ID: NCT05761561
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- have a diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, stage I-IV OR have a diagnosis of advanced or...
- 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
You likely can't join if
- 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...
- 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)
See the full 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.