Childhood Cancer SurvivorsNCT03523377
Overnight Fasting After Completion of Therapy: The OnFACT Study
A study testing prolonged overnight fasting in people with Childhood Cancer Survivors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Childhood Cancer Survivors
- What is being tested?
- prolonged overnight fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2018to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Childhood Cancer Survivors
- Being tested
- prolonged overnight fasting, usual care
- Keywords
- Fasting, 18-199
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prolonged overnight fastingOther
Three phone calls using motivational interviewing, support via SMS text.
usual careOther
Eat a heart-healthy diet and exercise for at least 30 minutes five days a week
| Study group | Role | What they receive |
|---|---|---|
| prolonged overnight fasting | Experimental | 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. Receives: Other: prolonged overnight fasting |
| usual care | Active comparator | 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. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation completion
Proportion of registered participants who successfully complete the 6-month intervention
Measured: 6 months
Secondary outcomes (1)
measure of glucose metabolism
Assess the effect of prolonged overnight fasting on glucose metabolism, measured by glycosylated hemoglobin (HbA1c).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start27 Apr 2018
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The OnFACT study is a pilot randomized controlled trial of prolonged overnight fasting among adult survivors of childhood cancer.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rockefeller University
- Responsible party
- Sponsor
- Investigators
- Danielle Friedman, MD, MS, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523377
- Sponsor's protocol ID
- 18-199
- Status last verified
- Jun 2026
- First submitted
- 1 May 2018
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overnight Fasting After Completion of Therapy: The OnFACT Study
- ClinicalTrials.gov ID
- NCT03523377
- Acronym / sponsor ID
- 18-199
- Conditions
- Childhood Cancer Survivors
- Keywords
- Fasting, 18-199
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Rockefeller University
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The OnFACT study is a pilot randomized controlled trial of prolonged overnight fasting among adult survivors of childhood cancer.
| Arm | Type | Receives |
|---|---|---|
| prolonged overnight fasting | Experimental | Other: prolonged overnight fastingParticipants 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. |
| usual care | Active comparator | Other: usual careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prolonged overnight fastingThree phone calls using motivational interviewing, support via SMS text. | Other | prolonged overnight fasting |
| usual careEat a heart-healthy diet and exercise for at least 30 minutes five days a week | Other | usual care |
Primary outcome
Participation completion
Time frame: 6 months
Proportion of registered participants who successfully complete the 6-month intervention
1 secondary outcome
measure of glucose metabolism
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Friedman, MD, MS principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prolonged overnight fasting in people with Childhood Cancer Survivors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation completion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.