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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This partially randomized clinical trial studies short-term fasting in reducing side effects in patients receiving gemcitabine hydrochloride and cisplatin for advanced solid tumors. Short-term fasting before chemotherapy may reduce the side effects caused by chemotherapy. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

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.

What data supports the effectiveness of fasting for reducing cancer side effects?

Research suggests that fasting, including intermittent fasting, may help make cancer treatments more effective and reduce side effects like vomiting and diarrhea. Studies indicate that fasting can protect healthy cells and make cancer cells more vulnerable during chemotherapy, potentially improving treatment outcomes. ^{1 2 3 4 5}

Is fasting safe for humans?

Short-term studies in humans, particularly those who are overweight or obese, suggest that intermittent fasting and energy restriction are generally safe and can improve insulin sensitivity and reduce inflammation. However, more long-term studies are needed to fully understand their safety in normal-weight individuals and across different health conditions. ^{3 6 7 8 9}

How does fasting help reduce cancer side effects?

Fasting is unique because it protects healthy cells from chemotherapy side effects while making cancer cells more vulnerable to treatment. Unlike other treatments, fasting takes advantage of the different ways normal and cancer cells respond to stress, potentially reducing side effects and improving treatment effectiveness. ^{3 4 7 10 11}

Research Team

David I Quinn, MD

Principal Investigator

University of Southern California

Eligibility Criteria

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.

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

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

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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]

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), 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]

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]

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]

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

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

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

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

4. England pubmed.ncbi.nlm.nih.gov

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

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

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

6. United States 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Energy restriction and the prevention of breast cancer. [2013]

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

Rationale for novel intermittent dieting strategies to attenuate adaptive responses to energy restriction. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Intermittent energy restriction induces changes in breast gene expression and systemic metabolism. [2022]

10. England pubmed.ncbi.nlm.nih.gov

When less may be more: calorie restriction and response to cancer therapy. [2020]

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

Impersonalized medicine. [2018]