- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03523377
Overnight Fasting After Completion of Therapy: The OnFACT Study
June 29, 2026 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to test whether regularly not eating for at least 14 hours overnight ("intermittent fasting") is feasible and can improve blood sugar.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Body mass index is ≥ 18.5 kg/m^2
- History of treatment for cancer or related illness diagnosed at ≤ 25 years old
- Off cytotoxic therapy for primary cancer ≥ 2 years
- Not receiving cytotoxic therapy (chemotherapy, external beam radiation therapy) at the time of study enrollment
- History of radiation to the chest, abdomen or total body
- Current age ≥18 years
- English-speaking
- Personal phone with SMS text messaging capability
- Willingness to wear an mHealth device, such as a FitBit, for two 7-day periods
- Able to perform all study requirements
Exclusion Criteria:
- Use of any antidiabetic, weight loss, or appetite control medication
- Use of any other medication that could impact dietary intake, such as prednisone
- Currently fasts 12 hours or more by self-report
- Unable to fast due to medical reason such as pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: prolonged overnight fasting
Participants randomized to the fasting arm will be instructed on how to use the SMS texting app to indicate the beginning and end of the nightly fast.
In the first 2-4 weeks following the first overnight fast, intervention participants will complete three phone calls with study staff trained in motivational interviewing.
These calls will be used to reinforce the prolonged overnight fasting instructions, identify barriers to prolonged overnight fasting, and support successes where they have occurred.
|
Three phone calls using motivational interviewing, support via SMS text.
|
|
Active Comparator: usual care
Participants randomized to the usual care arm will be instructed to eat a heart-healthy diet and exercise for at least 30 minutes five days a week, which is usual counseling in our clinics.
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Eat a heart-healthy diet and exercise for at least 30 minutes five days a week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation completion
Time Frame: 6 months
|
Proportion of registered participants who successfully complete the 6-month intervention
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
measure of glucose metabolism
Time Frame: 6 months
|
Assess the effect of prolonged overnight fasting on glucose metabolism, measured by glycosylated hemoglobin (HbA1c).
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Danielle Friedman, MD, MS, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 27, 2018
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
May 1, 2018
First Submitted That Met QC Criteria
May 1, 2018
First Posted (Actual)
May 14, 2018
Study Record Updates
Last Update Posted (Actual)
July 1, 2026
Last Update Submitted That Met QC Criteria
June 29, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-199
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.