Overnight Fasting for Health Improvement in Childhood Cancer Survivors

Overseen By Chaya Moskowitz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antidiabetics, Weight loss, Appetite control

Disqualifiers: Pregnancy, Fasting 12+ hours, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether fasting for at least 14 hours overnight, known as intermittent fasting, can improve blood sugar levels in childhood cancer survivors. It compares two groups: one practicing prolonged overnight fasting and another following usual healthy habits, such as a balanced diet and regular exercise. This study is suitable for individuals who had cancer, completed treatment over two years ago, have a BMI of at least 18.5, and are willing to participate in fasting and use a mobile health device. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance health outcomes for childhood cancer survivors.

Will I have to stop taking my current medications?

If you are taking any antidiabetic, weight loss, or appetite control medications, or medications that could affect your diet like prednisone, you will need to stop taking them to participate in this trial.

What prior data suggests that prolonged overnight fasting is safe for childhood cancer survivors?

Research suggests that extended overnight fasting might be safe for some cancer patients. Early studies show that fasting can help reduce chemotherapy side effects, potentially protecting healthy cells while still targeting cancer cells. Other studies found no harm from fasting and even linked it to positive changes, such as increased ketones, which the body produces when burning fat. Although more research is needed, current evidence suggests that fasting is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about prolonged overnight fasting for childhood cancer survivors because it offers a lifestyle-based approach that could complement existing care. Unlike traditional treatments that often involve medications or more invasive interventions, this method focuses on natural physiological processes—specifically, the body's ability to repair and rejuvenate during fasting periods. By leveraging a simple change in eating habits, prolonged overnight fasting may help improve health outcomes without the side effects associated with pharmaceuticals. Moreover, the use of motivational interviewing and digital tools for support adds an innovative layer, making it easier for participants to maintain this healthy routine.

What evidence suggests that prolonged overnight fasting might be an effective treatment for improving blood sugar in childhood cancer survivors?

Research has shown that prolonged overnight fasting can improve blood sugar levels. Studies have found that fasting for 13 hours or more at night links to better long-term blood sugar control, as measured by HbA1c levels. For breast cancer survivors, fasting for more than 13 hours each night also correlates with a lower risk of cancer recurrence. Early research suggests that fasting might reduce side effects from cancer treatments. In this trial, participants will be randomized to either a prolonged overnight fasting group or a usual care group. Overall, evidence suggests that extended overnight fasting could be a healthy practice for cancer survivors. ^{3 4 6 7 8}

Who Is on the Research Team?

Danielle Friedman, MD, MS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Adults over 18 who survived childhood cancer, speak English, can text, and have a personal phone. They must be off cancer treatments for at least 2 years and willing to wear a FitBit-like device. Not eligible if they already fast for 12+ hours, are pregnant, or take certain medications affecting diet or blood sugar.

Inclusion Criteria

Body mass index is ≥ 18.5 kg/m^2

Personal phone with SMS text messaging capability

English-speaking

Exclusion Criteria

Unable to fast due to medical reason such as pregnancy

Currently fasts 12 hours or more by self-report

I am not taking medications like prednisone that could affect my eating habits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in prolonged overnight fasting or usual care for 6 months

6 months

3 phone calls (for fasting group)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prolonged Overnight Fasting
• Usual Care

Trial Overview The OnFACT Study is testing if not eating for at least 14 hours overnight (intermittent fasting) is doable and beneficial for regulating blood sugar in adults who had cancer as children.

How Is the Trial Designed?

Group I: prolonged overnight fasting Experimental Treatment 1 Intervention

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.

Group II: usual care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Rockefeller University

Collaborator

Trials

162

Recruited

16,700+

Published Research Related to This Trial

A pilot study involving 40 women with a history of early-stage breast cancer showed that prolonged overnight fasting (POF) for 13 hours was feasible, with 95% of participants successfully fasting for at least 70% of the study nights.

Participants experienced significant improvements in anxiety, BMI, depression, and fatigue after 12 weeks of fasting, suggesting that POF may be a beneficial nonpharmacological intervention for improving certain health outcomes in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study to assess prolonged overnight fasting in breast cancer survivors (longfast). O'Donnell, E., Shapiro, Y., Comander, A., et al.[2022]

Long-term dietary restriction (DR) in rodents has been shown to significantly inhibit the development of cancer, suggesting that similar approaches could potentially increase human longevity by reducing cancer incidence.

Short-term fasting or intermittent fasting cycles do not provide lasting benefits against cancer and may even have negative effects, while a sustained DR of 1-3 months can effectively delay cancer onset by promoting the elimination of precancerous cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can short-term dietary restriction and fasting have a long-term anticarcinogenic effect? Klebanov, S.[2009]

Intermittent fasting may offer potential benefits for cancer patients by influencing metabolic and circadian rhythm mechanisms, but current clinical trials do not provide enough evidence to recommend it as a standard practice.

A major concern with intermittent fasting in cancer patients is the risk of caloric restriction, which could exacerbate issues like malnutrition and muscle loss, highlighting the need for careful consideration before implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting interventions to leverage metabolic and circadian mechanisms for cancer treatment and supportive care outcomes. Kalam, F., James, DL., Li, YR., et al.[2023]

Intermittent fasting (IF) during chemotherapy for breast cancer patients was found to be feasible and safe, potentially alleviating chemotherapy-induced adverse effects like fatigue and nausea, although the quality of the data was low.

While IF showed some promise in reducing chemotherapy-induced DNA damage and improving glycemic regulation, the review did not find significant benefits on quality of life or tumor recurrence, indicating that more rigorous studies are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Fasting in Breast Cancer: A Systematic Review and Critical Update of Available Studies. Anemoulis, M., Vlastos, A., Kachtsidis, V., et al.[2023]

In a study of 2413 women with early-stage breast cancer, those who fasted for less than 13 hours per night had a 36% higher risk of breast cancer recurrence compared to those who fasted for 13 hours or more, suggesting that longer nightly fasting may help reduce recurrence risk.

Each additional 2 hours of nightly fasting was associated with lower hemoglobin A1c levels and improved sleep duration, indicating that better glucoregulation and sleep may be mechanisms through which nightly fasting influences breast cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged Nightly Fasting and Breast Cancer Prognosis. Marinac, CR., Nelson, SH., Breen, CI., et al.[2022]

Fasting may enhance cancer treatment effectiveness and reduce side effects by creating conditions that hinder cancer cell survival and growth, as suggested by emerging evidence.

The review emphasizes the need for an integrated understanding of how fasting interacts with cancer therapies, recommending the combination of prolonged periodic fasting with standard treatments to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of fasting on cancer: A narrative review of scientific evidence. Tiwari, S., Sapkota, N., Han, Z.[2022]

Intermittent fasting, which involves alternating periods of food abstention and intake, shows promise in improving chemotherapy outcomes by reducing side effects like vomiting and diarrhea, and enhancing insulin sensitivity, based on preclinical studies.

Current data suggest that periodic fasting may enhance the effectiveness of chemotherapy and improve patient quality of life, but more extensive human trials are needed to confirm these benefits and explore different fasting methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Evidence and Directions for Intermittent Fasting During Cancer Chemotherapy. Gabel, K., Cares, K., Varady, K., et al.[2023]

The 5-day Fasting-Mimicking Diet (FMD) was found to be safe and feasible for cancer patients undergoing treatment, with only mild side effects reported during the study involving 90 participants.

FMD led to beneficial changes in body composition, including reduced fat mass and stable weight, while also decreasing levels of insulin and growth factors like IGF1 and leptin, suggesting potential metabolic benefits alongside cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Fasting-Mimicking Diet and Effects on Nutritional Status and Circulating Metabolic and Inflammatory Factors in Cancer Patients Undergoing Active Treatment. Valdemarin, F., Caffa, I., Persia, A., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12229459/

Time-restricted eating and cancer: lessons learned ... In addition to improved HbA1c, prolonged nightly fasting was associated with a statistically significant lower risk of disease recurrence in a cohort of breast ...

2. academic.oup.com academic.oup.com/nutritionreviews/article/83/7/e1660/7745808

Clinical Impact of Time-restricted Eating on Cancer Specifically, women who fasted for less than 13 hours per night were at increased risk of breast cancer recurrence compared with women who ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12547982/

Time-restricted eating to address persistent cancer-related ... In a randomized controlled trial, we tested the effects of TRE vs. control on fatigue in cancer survivorship.

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21694

Intermittent fasting in the prevention and treatment of cancer Preliminary studies suggest that prolonged fasting in some patients who have cancer is safe and potentially capable of decreasing chemotherapy-related toxicity ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04330339

Prolonged Nightly Fasting in Breast Cancer Survivors This study will examine if fasting for 13 hours per night is doable for participants and will also study what the effect of fasting is on quality of life, mood, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12166167/

The Clinical Impact of Time-restricted Eating on Cancer When overnight fasting extended into the morning, TRE resulted in statistically significant increases in ketones, cholesterol, and the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04722341

Time-Restricted Eating and Cancer: Clinical Outcomes ... Combining fasting with chemotherapy is known to cause complete tumor regression and long-term survival in animal models.

8. mdpi.com mdpi.com/2072-6643/13/10/3421

Fasting and Exercise in Oncology: Potential Synergism of ... Emerging evidence suggests fasting may have a protective effect on healthy cells allowing chemotherapy to exclusively target cancer cells.