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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Prolonged Overnight Fasting, Intermittent Fasting, Time-Restricted Eating, Prolonged Fasting, Usual Care, Standard Care, Conventional Care for health improvement in childhood cancer survivors?

Research on intermittent fasting in cancer patients suggests it may improve the effectiveness of treatments and reduce side effects like nausea and fatigue. While more studies are needed, fasting has shown potential benefits in improving treatment outcomes and quality of life during cancer therapy. ^{1 2 3 4 5}

Is overnight fasting safe for cancer survivors?

Research suggests that fasting, including intermittent and prolonged fasting, is generally safe for cancer patients, with mild side effects reported. However, there are concerns about nutritional risks, especially for those already prone to malnutrition, so it should be approached with caution and under medical supervision. ^{1 2 3 5 6}

How is the treatment of prolonged overnight fasting unique for childhood cancer survivors?

Prolonged overnight fasting is unique because it involves restricting food intake during specific times, which may positively influence cancer-related processes and improve health outcomes without the need for drugs. Unlike other treatments, it leverages natural metabolic and circadian rhythms to potentially enhance cancer treatment effectiveness and reduce side effects. ^{1 3 5 7 8}

What is the purpose of this trial?

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.

Research Team

Danielle Friedman, MD, MS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

Personal phone with SMS text messaging capability

Body mass index is ≥ 18.5 kg/m^2

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 (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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Pilot study to assess prolonged overnight fasting in breast cancer survivors (longfast). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Current Evidence and Directions for Intermittent Fasting During Cancer Chemotherapy. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effect of fasting on cancer: A narrative review of scientific evidence. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Intermittent Fasting in Breast Cancer: A Systematic Review and Critical Update of Available Studies. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Intermittent fasting interventions to leverage metabolic and circadian mechanisms for cancer treatment and supportive care outcomes. [2023]

6. Switzerland 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Prolonged Nightly Fasting and Breast Cancer Prognosis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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