Overnight Fasting After Completion of Therapy: The OnFACT Study

Childhood Cancer Survivors Clinical Trial

Official title:

Overnight Fasting After Completion of Therapy: The OnFACT Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03523377
• Other study ID #: 18-199
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2018
• Est. completion date: April 2026

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Danielle Friedman, MD, MS
• Phone: 212-639-7376
• Email: friedmad[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Childhood Cancer Survivors

Intervention

Other:
• prolonged overnight fasting
Three phone calls using motivational interviewing, support via SMS text.
• usual care
Eat a heart-healthy diet and exercise for at least 30 minutes five days a week

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation completion	Proportion of registered participants who successfully complete the 6-month intervention	6 months
Secondary	measure of glucose metabolism	Assess the effect of prolonged overnight fasting on glucose metabolism, measured by glycosylated hemoglobin (HbA1c).	6 months

External Links

•   Memorial Sloan Kettering Cancer Center