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

Trial Summary

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 data supports the effectiveness of intermittent fasting as a treatment during chemotherapy for ovarian cancer?

Research in mice with ovarian cancer shows that intermittent fasting can reduce factors that help tumors grow and boost the body's immune response against cancer. Additionally, studies in other cancers suggest that intermittent fasting may protect healthy cells and make cancer cells more sensitive to chemotherapy, potentially improving treatment outcomes. ^{1 2 3 4 5}

Is intermittent fasting safe during chemotherapy for ovarian cancer?

Research suggests that intermittent fasting may help protect healthy cells from chemotherapy side effects and improve quality of life by reducing fatigue. While specific safety data for ovarian cancer is limited, studies in other cancers indicate that intermittent fasting is generally safe and may enhance the effectiveness of chemotherapy. ^{1 2 6 7 8}

How does intermittent fasting differ from other treatments for ovarian cancer?

Intermittent fasting during chemotherapy for ovarian cancer is unique because it creates a tumor-hostile environment by reducing growth factors and enhancing the body's immune response, particularly by increasing certain immune cells that fight cancer. Unlike traditional treatments, it also helps protect healthy cells from chemotherapy side effects and may improve the overall quality of life by reducing fatigue. ^{1 2 4 5 6}

What is the purpose of this trial?

The goal of this clinical trial is to see if timed fasting (periods of time that you don't eat) in participants who are receiving chemotherapy prior to surgery is achievable, safe and can improve quality of life, symptoms and outcomes (results) compared to participants who receive standard dietary recommendations in individuals being treated for epithelial ovarian cancer . The main questions it aims to answer are: * Is it feasible to use intermittent fasting during neoadjuvant chemotherapy? * Is it safe to use intermittent fasting during neoadjuvant chemotherapy? * Do participants find it acceptable to use intermittent fasting during neoadjuvant chemotherapy? Researchers will compare participants who receive standard dietary recommendations to see which method is more achievable, safe, and able to improve quality of life, symptoms and outcomes. Participants will: * Receive either the fasting intervention (schedule of times when you do not eat) or standard diet recommendations for 6-9 weeks prior to your surgery starting with the second cycle of chemotherapy. * All participants will be asked to complete chemotherapy and surgery, cancer imaging, baseline screening tests, nutritional assessments, food diaries, blood tests, and surveys about wellbeing. * Participants in the intervention group will be asked to follow a fasting schedule that consists of not eating for 16 hours a day followed by normal eating for the remaining 8 hours of the day for 5 days in a row followed by 2 days of regular eating each week.

Research Team

Mariam AlHilli, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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 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]

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]

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]

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]

References

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

Intermittent fasting induced ketogenesis inhibits mouse epithelial ovarian cancer by promoting antitumor T cell response. [2023]

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

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

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

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

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

Teaching an Old Drug New Tricks. [2020]

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

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

6. Switzerland 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. [2023]

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

Alternate-day fasting reduces global cell proliferation rates independently of dietary fat content in mice. [2009]

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

A review of fasting effects on the response of cancer to chemotherapy. [2021]