Intermittent Fasting During Chemotherapy for Ovarian Cancer

Overseen By Jackie Ludwig

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Bowel obstruction, Severe malnutrition, Type I diabetes, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-9 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether intermittent fasting (abstaining from eating for specific periods) can be safe and beneficial for individuals undergoing chemotherapy before ovarian cancer surgery. Researchers aim to determine if this fasting method improves quality of life and treatment outcomes compared to standard dietary advice. Participants will either fast for 16 hours a day, 5 days a week, or follow regular meal guidelines during chemotherapy. The trial seeks participants with epithelial ovarian cancer who are receiving chemotherapy treatment. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance treatment experiences for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that intermittent fasting is safe during chemotherapy for ovarian cancer?

Research has shown that intermittent fasting might be safe for people undergoing chemotherapy. Some studies suggest that fasting can reduce chemotherapy side effects and might enhance treatment effectiveness.

Early findings in cancer patients indicate that fasting does not increase risks during treatment and might lower the chances of chemotherapy-related problems. Specifically, those who fast during chemotherapy might experience fewer side effects, such as nausea or fatigue.

Additionally, fasting is associated with weight loss and better blood sugar control, which can benefit those managing their weight or blood sugar levels.

Overall, current evidence supports the idea that intermittent fasting is well-tolerated and appears to be a safe option for those receiving chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intermittent fasting as a potential strategy during chemotherapy for ovarian cancer because it offers a novel approach to enhancing treatment effects and managing side effects. Unlike traditional treatments that focus solely on medication, intermittent fasting involves a specific eating pattern—16 hours of fasting followed by an 8-hour eating window—which may improve the body's response to chemotherapy. This method could help reduce the toxicity of chemotherapy drugs and improve patients' overall well-being. By possibly enhancing the effectiveness of chemotherapy while minimizing its harsh side effects, intermittent fasting presents a promising, non-invasive addition to current treatment options.

What evidence suggests that intermittent fasting could be effective for ovarian cancer?

This trial will compare intermittent fasting with standard dietary recommendations during chemotherapy for ovarian cancer. Research suggests that intermittent fasting might enhance chemotherapy's effectiveness. Studies have shown that fasting can reduce body weight, blood sugar, and insulin levels, which are beneficial during cancer treatment. In animal studies, intermittent fasting has been linked to longer survival times for those with ovarian tumors. Additionally, fasting may slow tumor growth, potentially improving chemotherapy outcomes. Although limited data exist on humans with ovarian cancer, these early findings present a promising area for further research. ^{1 3 6 7 8}

Who Is on the Research Team?

Mariam AlHilli, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a confirmed diagnosis of epithelial ovarian cancer, including fallopian tube and primary peritoneal cancer. It's for those who are planned to undergo or already receiving neoadjuvant chemotherapy (NACT) but haven't had surgical debulking yet.

Inclusion Criteria

My thinking and memory skills are normal.

My ovarian cancer is of an invasive type.

I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the fasting intervention or standard diet recommendations during neoadjuvant chemotherapy for 6-9 weeks prior to surgery

6-9 weeks

Visits coincide with chemotherapy cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of chemotherapy toxicity and quality of life

Up to 12 weeks post intervention

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Fasting

Trial Overview

The study tests if intermittent fasting during NACT is feasible, safe, and improves quality of life compared to standard diet recommendations in ovarian cancer patients. Participants will either fast for 16 hours daily or follow their usual diet before surgery.

How Is the Trial Designed?

Group I: Intermittent Fasting Experimental Treatment 2 Interventions

Participants will receive 16 hours of fasting, 8 hour regular feeding for 5 days a week starting 2 days prior to chemotherapy.

Group II: Standard of Care Active Control 1 Intervention

Participants will receive standard of care dietary recommendations and will provide a 3-day diet diary at study enrollment and during cycles 2 and 3.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

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]

Fasting before or during chemotherapy may enhance the effectiveness of cancer treatments by improving tumor cell responsiveness and protecting normal cells, as suggested by various mechanisms such as DNA repair and increased sensitivity to apoptosis.

While animal and in vitro studies indicate potential benefits of fasting in reducing tumor progression and enhancing chemotherapy efficacy, more human trials are needed to validate these findings due to the limited number of studies available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of fasting effects on the response of cancer to chemotherapy. Sadeghian, M., Rahmani, S., Khalesi, S., et al.[2021]

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]

In a study using mice with epithelial ovarian cancer (EOC), 16-hour intermittent fasting (IF) was found to significantly inhibit tumor growth and enhance anti-cancer immune responses by increasing key immune cells and creating an unfavorable environment for tumors.

The study revealed that β-hydroxy butyrate (BHB), a metabolite produced during IF, mimics some anticancer effects of fasting, but IF was more effective in improving survival and immune response, likely due to its role in promoting ketogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting induced ketogenesis inhibits mouse epithelial ovarian cancer by promoting antitumor T cell response. Udumula, MP., Singh, H., Rashid, F., et al.[2023]

Intermittent fasting can lower glucose levels in tumors, making them more responsive to the cancer drug metformin.

The study shows that using intermittent fasting before metformin treatment not only sensitizes resistant tumor cells but also significantly reduces tumor growth, suggesting a potential new strategy for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching an Old Drug New Tricks. Momcilovic, M., Shackelford, DB.[2020]

The IFAST trial aims to evaluate the effects of intermittent fasting on reducing fatigue and improving quality of life in women undergoing intravenous chemotherapy for gynecological cancers, with a primary focus on fatigue measured by the FACIT-FS scale.

Preliminary evidence suggests that fasting may enhance the quality of life during chemotherapy, and intermittent fasting could be a more manageable option for patients compared to prolonged fasting, potentially improving their tolerance to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intermittent fasting on quality of life tolerance of chemotherapy in patients with gynecological cancers: study protocol of a randomized-controlled multi-center trial. Schmidt, MW., Brenner, W., Gebhard, S., et al.[2023]

Modified alternate-day fasting (ADF) significantly reduces cell proliferation rates in various tissues, regardless of whether the diet is low-fat or high-fat, suggesting its potential as a cancer prevention strategy.

In a 4-week study with male mice, both ADF groups showed similar reductions in T-cell proliferation and decreased plasma insulin-like growth factor-1 levels, indicating that ADF can be effective across different dietary fat intakes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate-day fasting reduces global cell proliferation rates independently of dietary fat content in mice. Varady, KA., Roohk, DJ., Bruss, M., et al.[2009]

Peri-chemotherapy fasting is considered safe for well-nourished cancer patients undergoing short-term chemotherapy, with good patient compliance and only mild weight loss reported.

While some studies suggest potential benefits, such as improved tumor response in breast cancer, claims of significant oncological advantages from fasting during chemotherapy are currently premature and not well-supported by clinical data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calorie restriction in cancer patients undergoing chemotherapy: Facts, phantasy or misunderstanding. Bozzetti, F.[2022]

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Our findings suggest that IF is associated with successful weight loss and metabolic benefits among adults with obesity. MADF and the 5:2 diet ...