Fasting for Cancer Side Effect Reduction

Overseen By America Casillas-Lopez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Diabetes, Cardiac disease, Neuropathy, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether short-term fasting can reduce chemotherapy side effects for people with advanced solid tumors. Participants will fast for varying periods before chemotherapy to assess any impact on their well-being. The study examines fasting for 24, 48, or 72 hours before treatment. This trial may suit individuals with solid tumor cancers who are planning or currently receiving platinum-based chemotherapy and have not experienced significant recent weight loss without trying. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance chemotherapy experiences.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes participants on medications that cannot be safely stopped during fasting or taken without food.

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

Research shows that fasting can be safe for cancer patients. Studies have found that fasting, even for a short time, usually causes only mild side effects like headaches, dizziness, nausea, and tiredness. In some cases, fasting can actually help lessen chemotherapy side effects, such as nausea and tiredness.

One study found that patients who fasted experienced fewer chemotherapy side effects compared to those who did not fast. Another study noted that most patients felt fasting improved their chemotherapy experience.

While fasting is generally safe, not eating for too long can lead to serious issues like excessive weight loss or anemia (a low count of red blood cells). However, in controlled settings like clinical trials, researchers carefully manage these risks. Always consult a healthcare provider before trying fasting, especially during cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about fasting protocols for reducing cancer treatment side effects because they offer a non-drug approach to support patients' well-being. Unlike standard care options, which often involve medications to manage symptoms, fasting may enhance the body's resilience to chemotherapy by giving cells a break from processing nutrients. The study investigates different fasting durations, from 24 to 72 hours, to determine the most effective and manageable approach for patients. This method is unique because it leverages the body's natural metabolic processes, potentially leading to fewer side effects and improved tolerance to cancer treatments.

What evidence suggests that fasting might be effective in reducing side effects for cancer patients undergoing chemotherapy?

Research suggests that fasting might help lessen the side effects of chemotherapy. Some studies have found that fasting can reduce symptoms like tiredness and nausea in patients receiving treatment. Evidence indicates that fasting could even enhance chemotherapy's effectiveness, possibly slowing tumor growth. In small studies, patients who fasted before cancer treatment reported fewer side effects than those who didn't fast. This trial will explore different fasting durations: participants in Group I will fast for 24 hours, Group II for 48 hours, Group III for 72 hours, and Group IV will undergo a modified 48-hour fast. The idea is that fasting might protect healthy cells while making cancer cells more vulnerable to treatment. Overall, while more research is needed, early findings are promising. ^{2 4 6 7 8}

Who Is on the Research Team?

David I Quinn, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced solid tumors who are recommended platinum-based chemotherapy. They must have adequate kidney function, an ECOG performance status of 0-1, and a BMI above 18.5. Women must not be pregnant and agree to use contraception. Exclusions include diabetes, recent unexplained weight loss, severe neuropathy or heart disease, certain medications that can't be stopped during fasting, or health issues making fasting dangerous.

Inclusion Criteria

I've had limited chemotherapy and none recently for my cancer stage.

Premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period

You have a body mass index (BMI) above 18.5.

Exclusion Criteria

I have not had any recent, unexplained weight loss that could be risky.

I do not have severe numbness or pain in my hands or feet.

I take medications that cannot be stopped or must be taken with food.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo fasting and receive chemotherapy with gemcitabine hydrochloride and cisplatin. Fasting durations vary by group: 24, 48, or 72 hours before chemotherapy.

12 weeks

4 cycles of treatment every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fasting
• Modified fast
• Short-term fasting

Trial Overview The study examines if short-term fasting before receiving gemcitabine hydrochloride and cisplatin reduces side effects in patients with advanced tumors. Participants will either fast or follow a modified fast prior to chemotherapy to see if it impacts the treatment's toxicity.

How Is the Trial Designed?

Group I: Group IV (Stage I of study) Experimental Treatment 2 Interventions

Patients undergo a modified 48-hour fast with minimal caloric intake on day -2 and -1

Group II: Group III (Stage I of study) Experimental Treatment 2 Interventions

Patients fast for 72 hours on days -3, -2, and -1

Group III: Group II (Stage I of study) Experimental Treatment 2 Interventions

Patients fast for 48 hours on days -2 and -1

Group IV: Group I (Stage I of study) Experimental Treatment 2 Interventions

Patients fast for 24 hours on day -1

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

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]

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]

Habitual continuous energy restriction (CER) has been shown to effectively prevent breast tumor formation in both animal studies and observational studies in women, while intermittent energy restriction (IER) and intermittent fasting (IF) may offer easier and potentially more effective alternatives for weight control and cancer prevention.

Animal studies suggest that IER and IF can reduce mammary tumor formation and may have different mechanisms of action compared to CER, including greater reductions in fat stores and improved insulin sensitivity, but more research is needed to directly compare these methods in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy restriction and the prevention of breast cancer. Harvie, M., Howell, A.[2013]

Intermittent energy restriction (IER) has been shown in animal studies to be more effective than continuous energy restriction (CER) in reducing tumor rates, suggesting potential anticancer benefits.

Limited human studies indicate that IER may improve insulin sensitivity more than CER in overweight and obese individuals, but more long-term research is needed to confirm these findings and assess safety and efficacy in both overweight and normal-weight populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could Intermittent Energy Restriction and Intermittent Fasting Reduce Rates of Cancer in Obese, Overweight, and Normal-Weight Subjects? A Summary of Evidence. Harvie, MN., Howell, T.[2023]

Intermittent energy restriction (IER), such as intermittent fasting, does not lead to greater weight loss compared to continuous energy restriction (CER), where daily energy intake is consistently limited.

Achieving energy balance during refeeding phases of IER may enhance weight loss outcomes, as some studies suggest that this approach could mitigate adaptive responses that hinder ongoing weight loss, although results from existing trials are mixed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale for novel intermittent dieting strategies to attenuate adaptive responses to energy restriction. Sainsbury, A., Wood, RE., Seimon, RV., et al.[2019]

Calorie restriction (CR) and intermittent fasting have been shown to enhance the effectiveness of cancer treatments like chemotherapy and radiation therapy, while also reducing side effects associated with these therapies.

CR mimetic drugs and alternative diets, such as the ketogenic diet, show promise in improving anticancer therapy outcomes, suggesting that these approaches could be beneficial in future clinical studies for various types of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When less may be more: calorie restriction and response to cancer therapy. O'Flanagan, CH., Smith, LA., McDonell, SB., et al.[2020]

Intermittent energy restriction (IER) led to a significant weight loss of 4.8% and reduced insulin resistance by nearly 30% during restricted days in 23 overweight premenopausal women at high risk for breast cancer, suggesting potential metabolic benefits.

The study found variable transcriptional responses in breast tissue to IER, with some women showing beneficial gene expression changes related to breast epithelial cell differentiation, while others did not exhibit any significant changes, indicating that individual responses to IER may differ and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent energy restriction induces changes in breast gene expression and systemic metabolism. Harvie, MN., Sims, AH., Pegington, M., 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]

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]

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]

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]

Citations

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

Fasting as Cancer Treatment: Myth or Breakthrough in ... Fasting may not only reduce the side effects of chemotherapy and radiation but also improve their effectiveness. Cancer cells are known for ...

2. 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).

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1044579X20302005

The effect of caloric restriction and fasting on cancer Increasing preclinical evidence indicates that caloric restriction (CR) and fasting might have anticancer effects by reducing tumor progression, enhancing ...

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-53702400098-1/fulltext

Intermittent fasting and health outcomes: an umbrella ... Benefits of Intermittent fasting (IF) on health-related outcomes have been found in a range of randomised controlled trials (RCTs).

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7981322/

Energy and caloric restriction, and fasting and cancer Moreover, fasting may cause mild side effects, including headaches, dizziness, nausea, dyspepsia, and fatigue. Conclusion. As nutrition and metabolism are ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11614448/

Intermittent Fasting and Its Impact on Toxicities, Symptoms ... Qualitatively, 14 of 16 patients reported that fasting improved adverse effects of chemotherapy including nausea, vomiting, and fatigue, along with improved ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523125172

Health effects of intermittent fasting: hormesis or harm? A ... Starvation causes excessive weight loss, anemia, chronic diarrhea, delirium, and other adverse reactions and eventually death. Intermittent therapeutic fasting ...