No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Supportive Care
Participants needed
200 (estimated)
Sponsor
Yale University · Other
Who this trial is looking for
This trial is looking for women who have recently been diagnosed with ovarian or endometrial cancer and are starting chemotherapy. Participants will receive support for exercise and nutrition during their treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with stage I-IV ovarian cancer or advanced endometrial cancer.
My treatment includes carboplatin and taxane.
I am scheduled for at least 6 cycles of chemotherapy.
I can walk without assistance.
I can read and understand instructions in English or Spanish.
I agree to be randomly assigned to either the exercise group or the control group.
I have permission from my oncologist to participate.
I am at least 18 years old.
You may not be able to join if
I have already completed 2 cycles of chemotherapy.
I have been following strict dietary guidelines with over 7 servings of fruits and vegetables daily.
I have been exercising regularly with over 150 minutes per week of moderate to vigorous activity since my diagnosis.
I am pregnant or planning to become pregnant.
I had a stroke or heart attack in the last year.
I have major psychiatric issues or dementia.
I am receiving treatment for another cancer, except for hormone therapy.
I am receiving external beam radiation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 m…
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 Locations
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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)
…
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
Contacts
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