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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be scheduled to receive neoadjuvant or adjuvant chemotherapy
Be ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
TEAL Trial Summary
This trial will test if exercise and nutrition counseling during chemo helps treat ovarian cancer. 200 women will get counseling along with chemo, monitored to see if it helps.
Who is the study for?
This trial is for women over 18 with newly diagnosed ovarian cancer who are about to start chemotherapy. They must be able to walk unaided and understand English or Spanish. Women can't join if they're pregnant, have severe mental health issues, are in active treatment for another cancer (except hormone therapy), have already started their second chemo cycle, follow certain diet/exercise guidelines since diagnosis, or have had recent serious heart problems.Check my eligibility
What is being tested?
The study tests how exercise and medical nutrition affect women undergoing chemotherapy for ovarian cancer. Participants will either receive weekly counseling sessions on these interventions during their chemo treatment or be placed in a control group without the intervention. Assessments occur at baseline, after chemo/end of intervention, and one year post-diagnosis.See study design
What are the potential side effects?
Since this trial focuses on exercise and nutrition rather than medication, side effects may include typical reactions to new exercise routines such as muscle soreness or fatigue. Nutritional changes might cause digestive adjustments but aren't expected to cause severe side effects.
TEAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for chemotherapy before or after surgery.
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I am 18 years old or older.
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I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.
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I can walk without using any aids like a cane or walker.
TEAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Chemotherapy completion rate (relative dose intensity)
Secondary outcome measures
Change in Arthralgia
Change in BMI
Change in Cognitive function
+22 moreTEAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise and medical nutritionExperimental Treatment1 Intervention
Over the intervention period (18 weeks on average - dependent on length of chemotherapy) women in the intervention arm will receive weekly counseling sessions, the study dietitian and exercise trainer will each conduct weekly sessions to assist the participants in achieving the diet and exercise study goals.
Group II: ControlActive Control1 Intervention
Contact limited to study assessments.
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,166 Total Patients Enrolled
2 Trials studying Ovarian Cancer
175 Patients Enrolled for Ovarian Cancer
University of MiamiOTHER
901 Previous Clinical Trials
409,786 Total Patients Enrolled
2 Trials studying Ovarian Cancer
292 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,933 Total Patients Enrolled
285 Trials studying Ovarian Cancer
73,566 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe memory loss or serious mental illness.I can read and understand English or Spanish for forms and instructions.I am 18 years old or older.I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.I am scheduled for chemotherapy before or after surgery.I have not had a stroke, heart attack, or severe heart failure in the past year.You are already following a healthy diet and exercising regularly since your diagnosis.I am not on any targeted or biological cancer treatments, except hormone therapy.I can walk without using any aids like a cane or walker.I have finished my second round of chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise and medical nutrition
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots in this clinical experiment that individuals can fill?
"According to clinicaltrials.gov, this medical trial is no longer actively recruiting participants. It was initially posted on March 1st 2023 and the last update occurred on February 27th of the same year. Nevertheless, there are 672 other studies that still need volunteers at present."
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