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Trial Title:
Trial of Exercise and Lifestyle in Women With Ovarian Cancer
NCT ID:
NCT05761561
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise and medical nutrition
Description:
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 weekly strength training sessions; 3) eat a combination of
5 or more servings of vegetables and/or fruits per day 4) consume 25 grams or more of
fiber/day; 5) consume adequate amounts of protein to prevent muscle wasting (1.2g/kg body
weight).
Arm group label:
Exercise and medical nutrition
Summary:
An anticipated 200 women with newly diagnosed ovarian 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 OC 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 18-week exercise and medical nutrition intervention or attention control 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 (3-months post-chemotherapy and 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- have a diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal
carcinoma, stage I-IV
- be scheduled to receive 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 (>5 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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06511
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melinda Irwin, PhD
Phone:
203-499-9405
Email:
melinda.irwin@yale.edu
Contact backup:
Phone:
203-499-9405
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tracy Crane, PhD
Phone:
305-243-9832
Email:
Tecrane@miami.edu
Start date:
April 19, 2023
Completion date:
June 2027
Lead sponsor:
Agency:
Yale University
Agency class:
Other
Collaborator:
Agency:
University of Miami
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Yale University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05761561
