60 Participants Needed

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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.

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.12345

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.13567

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.14589

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.

Research Team

YR

Yun R. Li

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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.
See 2 more

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.
See 18 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (time-restricted eating)Experimental Treatment4 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 Control4 Interventions
Patients receive nutritional counseling on study. Patients also undergo collection of blood throughout the trial.

Find a Clinic Near You

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+

Findings from Research

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

References

Protective effects of short-term dietary restriction in surgical stress and chemotherapy. [2018]
Psychosocial Support in Cancer Cachexia Syndrome: The Evidence for Supported Self-Management of Eating Problems during Radiotherapy or Chemotherapy Treatment. [2022]
Intermittent fasting during adjuvant chemotherapy may promote differential stress resistance in breast cancer patients. [2022]
Fasting and weight-loss restrictive diet practices among 2,700 cancer survivors: results from the NutriNet-Santé cohort. [2019]
Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. [2022]
Implementing a low-fat eating plan in the Women's Intervention Nutrition Study. [2021]
Pilot study to assess prolonged overnight fasting in breast cancer survivors (longfast). [2022]
Effects of short-term dietary restriction on survival of mammary ascites tumor-bearing rats. [2019]
Impersonalized medicine. [2018]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security