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 studies if time-restricted eating can reduce side effects of radiation or chemoradiation in patients with prostate, cervical, and rectal cancers. It compares fasting periods to nutritional counseling to see which helps more with treatment side effects and overall health.

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 time-restricted eating safe for humans, especially during cancer treatment?

Research suggests that short-term fasting and intermittent fasting during cancer treatment may protect healthy cells from chemotherapy side effects and improve surgical outcomes, indicating it is generally safe for humans. ^{1 2 3 4 5}

How does time-restricted eating differ from other treatments for reducing cancer side effects?

Time-restricted eating is unique because it involves limiting food intake to specific hours of the day, which may help reduce cancer side effects by exploiting differences in how tumor and normal cells respond to stress. This approach can enhance the effectiveness of chemotherapy and improve surgical outcomes by strengthening normal cells and weakening tumor cells, unlike traditional treatments that do not focus on meal timing. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Time-Restricted Eating for Cancer Side Effect Reduction?

Research suggests that short-term fasting and intermittent fasting can protect healthy cells and make cancer cells more vulnerable during chemotherapy, potentially reducing side effects. Additionally, nutritional counseling and self-management of eating problems can improve nutritional intake and quality of life for cancer patients. ^{1 2 3 6 9}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Protective effects of short-term dietary restriction in surgical stress and chemotherapy. [2018]

2. United States 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. [2022]

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

Intermittent fasting during adjuvant chemotherapy may promote differential stress resistance in breast cancer patients. [2022]

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

Fasting and weight-loss restrictive diet practices among 2,700 cancer survivors: results from the NutriNet-Santé cohort. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. [2022]

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

Implementing a low-fat eating plan in the Women's Intervention Nutrition Study. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Effects of short-term dietary restriction on survival of mammary ascites tumor-bearing rats. [2019]

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

Impersonalized medicine. [2018]