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Fasting Intervention for Ovarian Cancer (FAST Trial)
N/A
Recruiting
Led By Jenna Marcus, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed or high suspicion for endometrial, ovarian, fallopian tube or primary peritoneal cancer, and are able and expecting to undergo adjuvant chemotherapy following hysterectomy for treatment of disease, as determined by their treating physician
ECOG status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks
Awards & highlights
FAST Trial Summary
This trial will investigate the effects of fasting & ketogenic diets on side effects & quality of life of women with endometrial & ovarian cancer.
Who is the study for?
This trial is for women over 18 with confirmed or suspected endometrial, ovarian, fallopian tube, or primary peritoneal cancer who are fluent in English and have internet access. They must be planning to receive chemotherapy after surgery at Northwestern Medicine and have an ECOG status of 0 or 1.Check my eligibility
What is being tested?
The study tests the effects of alternate day fasting on side effects and quality of life during chemotherapy for gynecologic cancers. It aims to see if this diet regimen can reduce the negative impact of standard chemotherapeutic treatment.See study design
What are the potential side effects?
While specific side effects aren't listed for the FAST Intervention, fasting may cause fatigue, dizziness, headaches, low blood sugar levels (hypoglycemia), and could affect how other medications work.
FAST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am expected to have chemotherapy after a hysterectomy for my cancer.
Select...
I am fully active or can carry out light work.
FAST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment Compliance
Fasting non-compliance
Treatment Compliance
Secondary outcome measures
Adverse events and toxicity
Neuropathic Pain
Physical Function
Other outcome measures
Cancer Related Fatigue
Molecular biomarker: Estrone
Molecular biomarker: Insulin
+5 moreFAST Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FAST GroupExperimental Treatment1 Intervention
The FAST intervention will consist of one week of alternate day fasting (ADF) using the sandwich model at the start of each cycle of chemotherapy, for a total of 6 weeks of ADF. Patients will be instructed on how and what they may consume on fasting days.
Group II: Control GroupActive Control1 Intervention
Participants in the control arm will be instructed to eat as desired throughout their entire chemotherapy treatment course. Control group participants will not receive any special study- related instructions or direction regarding food and drinks consumed during chemotherapy.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
917,057 Total Patients Enrolled
4 Trials studying Endometrial Cancer
6,267 Patients Enrolled for Endometrial Cancer
Jenna Marcus, MDPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You work night shifts or late shifts.I have had cancer treatment within the last 2 years.My physical activity is somewhat limited but I can still take care of myself.I do not have diabetes, recent heart attack, stroke, blood clots in lungs, kidney failure, or any condition that prevents fasting.I am not planning to have chemotherapy at Northwestern Medicine.My BMI is over 50 or I have an eating disorder, and I don't take insulin or blood thinners.I am a woman aged 18 or older.I am fully active or can carry out light work.I am expected to have chemotherapy after a hysterectomy for my cancer.My doctor will adjust my medication if fasting affects my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: FAST Group
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 researchers presently enrolling participants for this investigation?
"According to the clinicaltrials.gov website, this study is not currently accepting candidates and was last edited on August 4th 2023. In spite of that fact, there are 900 other medical trials actively recruiting patients at present."
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