Time-Restricted Eating for Cancer Side Effect Reduction

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must be taking: Androgen deprivation, Cisplatin, 5FU

Must not be taking: Docetaxel

Disqualifiers: Prior radiation, Prior chemotherapy, BMI less than 21, Strict diets, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how time-restricted eating, a type of intermittent fasting, might reduce side effects of radiation treatments for prostate, cervical, and rectal cancers. Researchers aim to determine if set fasting periods can enhance the effectiveness of radiation therapy and reduce its side effects, compared to following nutritional advice alone. Participants will either practice time-restricted eating or receive guidance on maintaining a healthy diet (nutritional counseling) during their treatment. Individuals diagnosed with one of these cancers and experiencing side effects from radiation or chemoradiation might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have diabetes, you may need to hold your diabetes medication during the fasting periods, but only if your doctor agrees it's safe.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that time-restricted eating, also known as intermittent fasting, might be manageable for cancer patients. Some studies have found that short-term fasting can help patients cope better with chemotherapy. In one small study, patients who fasted felt less tired and weak and experienced fewer stomach problems compared to those who didn't fast.

These results suggest that fasting could safely lessen the side effects of cancer treatments. However, everyone reacts differently, and more research is needed to fully understand its effects. Always consult a healthcare professional before changing your diet during treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about time-restricted eating as a potential way to reduce cancer treatment side effects because it offers a unique approach compared to traditional methods. Unlike typical strategies that might involve medication to manage side effects, time-restricted eating focuses on limiting food intake to specific hours of the day, which might enhance the body’s natural repair processes and improve patient well-being during treatments like radiation or chemotherapy. Additionally, nutritional counseling provides personalized dietary guidance, which can help patients make informed food choices to support their overall health and treatment outcomes. This trial could reveal important insights into how simple lifestyle adjustments might complement conventional cancer therapies.

What evidence suggests that this trial's treatments could be effective for reducing cancer treatment side effects?

Research has shown that time-restricted eating, a type of intermittent fasting, might reduce the side effects of radiation and chemoradiation in cancer treatment. In this trial, participants in one arm will follow a time-restricted eating regimen. Studies have found that fasting can increase cancer cells' sensitivity to treatment while protecting normal cells from chemotherapy's harmful effects. This method might also enhance the overall effectiveness of cancer treatments. Some evidence suggests that fasting could lower the risk of cancer recurrence, such as in breast cancer. Overall, early findings are promising and suggest that time-restricted eating could effectively manage cancer treatment side effects. ^{1 4 6 7 8}

Who Is on the Research Team?

Yun R. Li

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with high-risk prostate, advanced rectal, or cervical cancer who are about to receive radiation or chemoradiation. They must be in good enough health to participate (ECOG 0-2) and not have had certain prior treatments like long-term hormone therapy for prostate cancer or any chemotherapy. Pregnant women, those planning pregnancy, lactating women, individuals on strict diets such as keto or paleo, and those with a BMI under 21 are excluded.

Inclusion Criteria

I am 18 or older with advanced rectal cancer getting radiation and chemotherapy.

Able to provide a written consent for study participation

I am 18 or older with high-risk or node-positive prostate cancer, confirmed by biopsy, planning to receive radiation therapy.

Exclusion Criteria

RECTAL CANCER: Patients who are currently undergoing a strict macronutrient or time limited diet including ketogenic, low-carb, paleo, or warrior diet are excluded

My BMI is under 21 and I have gynecologic cancer.

I am a man with prostate cancer not planning to start with docetaxel treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo time-restricted eating or receive nutritional counseling during radiation or chemoradiation therapy. Blood samples are collected throughout the trial.

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and adverse events.

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Nutritional Counseling
• Time-Restricted Eating

Trial Overview The study compares the effects of time-restricted eating (intermittent fasting) versus nutritional counseling on reducing side effects from radiation or chemoradiation treatment in patients with specific cancers. Researchers want to see if these dietary approaches can enhance the effectiveness of cancer treatments and lessen their adverse effects.

How Is the Trial Designed?

Group I: Arm I (time-restricted eating) Experimental Treatment 4 Interventions

Patients undergo time-restricted eating Monday through Friday only of each week on study during standard RT or chemoRT. Patients also undergo collection of blood throughout the trial.

Group II: Arm II (nutritional counseling) Active Control 4 Interventions

Patients receive nutritional counseling on study. Patients also undergo collection of blood throughout the trial.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Short-term dietary restriction, involving alternate day feeding and fasting, significantly improved survival rates in tumor-bearing Fisher rats, with 66.7% surviving 9 days post-tumor inoculation compared to only 20.8% in the control group.

The study suggests that mild dietary restrictions could be beneficial in enhancing survival and potentially inhibiting cancer growth, indicating a need for further clinical trials in human cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of short-term dietary restriction on survival of mammary ascites tumor-bearing rats. Siegel, I., Liu, TL., Nepomuceno, N., et al.[2019]

Intermittent fasting (IF) during chemotherapy for breast cancer patients significantly reduced gastrointestinal toxicity compared to a non-fasting group, suggesting a protective effect of fasting against chemotherapy side effects.

The study, involving 48 HER2-negative breast cancer patients, also indicated that IF improved metabolic profiles, as evidenced by lower insulin levels in the IF group, which may enhance the overall efficacy of chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting during adjuvant chemotherapy may promote differential stress resistance in breast cancer patients. Omar, EM., Omran, GA., Mustafa, MF., et al.[2022]

The Women's Intervention Nutrition Study demonstrated that a low-fat eating plan significantly reduced dietary fat intake in women with early-stage breast cancer, achieving a reduction from 31.2% to 23.2% of energy from fat over 5 years (P<0.0001).

Participants in the intervention group also experienced a mean weight loss of 6.1 lbs compared to the control group, suggesting that this lifestyle change may positively impact breast cancer recurrence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a low-fat eating plan in the Women's Intervention Nutrition Study. Hoy, MK., Winters, BL., Chlebowski, RT., et al.[2021]

Short-term fasting can enhance the effectiveness of chemotherapy by taking advantage of the different stress responses of tumor cells compared to normal cells.

Fasting not only helps protect normal cells but also makes tumor cells more vulnerable to the toxic effects of chemotherapy, potentially improving treatment outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impersonalized medicine. Scrable, H.[2018]

In a study involving 172 women undergoing chemotherapy, intermittent energy restriction (IER) showed a trend towards greater weight and body fat reduction compared to continuous energy restriction (CER), particularly after adjusting for body water.

While the overall incidence of severe chemotherapy toxicities was similar between IER and CER, there was a trend indicating fewer severe toxicities in the IER group during later cycles of treatment, suggesting IER may help reduce treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. Harvie, M., Pegington, M., Howell, SJ., et al.[2022]

Reduced caloric intake and dietary composition may enhance longevity and reduce the severity of aging-related diseases like cancer, suggesting that diet plays a crucial role in health outcomes.

The review proposes that preventive dietary recommendations could improve cancer treatment efficacy and surgical outcomes, highlighting the need for clearer nutritional guidance for patients undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective effects of short-term dietary restriction in surgical stress and chemotherapy. Brandhorst, S., Harputlugil, E., Mitchell, JR., et al.[2018]

Among 2,741 cancer survivors, 13.8% reported practicing weight-loss restrictive diets, with a higher prevalence in women, those who are overweight/obese, and individuals with breast cancer, indicating a significant trend towards dietary control post-diagnosis.

Fasting was practiced by 6.0% of participants, often associated with the belief that it could improve cancer prognosis; however, those receiving nutritional guidance from healthcare professionals were less likely to engage in fasting or restrictive diets, highlighting the importance of professional dietary advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting and weight-loss restrictive diet practices among 2,700 cancer survivors: results from the NutriNet-Santé cohort. Fassier, P., Srour, B., Raynard, B., et al.[2019]

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]

Cancer patients often face eating problems that can lead to malnutrition and weight loss, which negatively impact treatment outcomes and overall health.

Nutritional counseling and support for self-management can improve nutritional intake and quality of life, particularly for patients with head and neck, gastrointestinal, and lung cancers, but more research is needed on how to effectively engage patients in their nutritional care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial Support in Cancer Cachexia Syndrome: The Evidence for Supported Self-Management of Eating Problems during Radiotherapy or Chemotherapy Treatment. Hopkinson, J.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12035504/

Fasting as Cancer Treatment: Myth or Breakthrough in ... Fasting induces a stress-resistant state in normal cells, reducing chemotherapy toxicity, while cancer cells become more vulnerable. Improves ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05722288

NCT05722288 | Time-Restricted Eating Versus Nutritional ... This phase II trial studies how well time-restricted eating works in reducing side effects of radiation or chemoradiation side effects when compared to ...

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

Time-restricted eating and cancer: lessons learned ... Studies report metabolic syndrome is associated with increased risk for liver, colorectal, and bladder cancers in males and endometrial, pancreatic, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322000837

Current Evidence and Directions for Intermittent Fasting ... Available data show that periodic fasting, a form of intermittent fasting, may hold potential to improve the effectiveness of chemotherapy, decrease treatment- ...

5. 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 ...

6. osher.ucsf.edu osher.ucsf.edu/patient-care/integrative-medicine-resources/cancer-and-nutrition/faq/cancer-and-fasting-calorie-restriction

Cancer and Fasting / Calorie Restriction A small study (n=6) reported a reduction in fatigue, weakness, and gastrointestinal side effects, compared to receiving chemotherapy without fasting (5). As ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05722288

NCT05722288 | Time-Restricted Eating Versus Nutritional ... This phase II trial studies how well time-restricted eating works in reducing side effects of radiation or chemoradiation side effects when compared to ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305737224000525

Intermittent fasting and its impact on toxicities, symptoms ... In this review, we examine extant scientific literature on intermittent fasting interventions in patients undergoing active pharmacological cancer treatment.