Fasting Mimicking Diet + Chemotherapy for Ovarian Cancer

Overseen By Michele Britto, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Endeavor Health

Must not be taking: Antiglycemics

Disqualifiers: Malnutrition, Eating disorders, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: 18-30 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special diet that mimics fasting can reduce chemotherapy side effects for patients with advanced or recurrent ovarian, fallopian tube, and primary peritoneal cancer. Researchers aim to determine if this diet, combined with the chemotherapy drugs carboplatin and paclitaxel, can decrease toxicity and improve tumor response to treatment. Participants will either follow their usual diet or the fasting-mimicking diet during treatment cycles. Those living with advanced ovarian, fallopian tube, or primary peritoneal cancer and planning to start chemotherapy might be suitable for this trial, especially if their cancer previously responded to platinum-based treatments. As an unphased trial, this study offers a unique opportunity to explore innovative dietary approaches that could enhance the treatment experience.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have diabetes that requires medication, you cannot participate in the trial.

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

Research has shown that the fasting mimicking diet (FMD) might help reduce the side effects of chemotherapy drugs like carboplatin and paclitaxel. In a previous study with breast cancer patients, those who followed the FMD needed less medication for nausea, and their responses to cancer treatment improved.

Another study found that the FMD was generally safe, with only mild side effects. Patients maintained their weight and strength and even saw some improvements in muscle mass. These findings suggest that adding FMD to chemotherapy could lower the risk of severe side effects without reducing its effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of a Fasting Mimicking Diet (FMD) with chemotherapy for ovarian cancer because it offers a novel approach to enhancing treatment effectiveness. Unlike standard chemotherapy regimens, which typically involve a regular diet, this experimental approach incorporates a specialized diet that mimics fasting. This diet is thought to potentially boost the body's response to chemotherapy by reducing side effects and enhancing cancer cell sensitivity to the drugs. By integrating FMD with carboplatin and paclitaxel, researchers hope to improve outcomes for patients, making chemotherapy more tolerable and effective.

What evidence suggests that the fasting mimicking diet combined with chemotherapy could be effective for ovarian cancer?

Research shows that a fasting mimicking diet (FMD) might help reduce chemotherapy side effects. In studies with breast cancer patients, those who followed FMD during treatment needed fewer anti-nausea medications and responded better to treatment. Although specific data for ovarian cancer is limited, this trial will evaluate the effects of FMD combined with chemotherapy for ovarian cancer. Participants in one arm of this trial will receive Carboplatin and Paclitaxel with a standard diet, while those in another arm will receive the same chemotherapy regimen with FMD. FMD aims to protect healthy cells and enhance chemotherapy effectiveness by imitating fasting, potentially reducing side effects while maintaining or improving treatment efficacy. This promising approach is under further study to determine if it offers similar benefits for ovarian cancer treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Mary T Jenkins Vogel, MD

Principal Investigator

Endeavor Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced or recurrent ovarian, fallopian tube, and primary peritoneal cancers suitable for chemotherapy. Participants must have been platinum-sensitive if recurrent, have a good performance status (able to carry out daily activities), normal blood counts and organ function, and a BMI of at least 19. Those with malnutrition, eating disorders, diabetes needing medication or allergies to the diet's components cannot join.

Inclusion Criteria

My kidney function is normal, based on my creatinine levels.

My blood tests show enough white blood cells and platelets.

I have advanced ovarian, fallopian tube, or peritoneal cancer and am a candidate for initial chemotherapy.

Exclusion Criteria

You have been diagnosed with an active eating disorder.

You are underweight or have poor nutrition.

You are allergic to any part of the fasting mimicking diet (FMD).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive carboplatin and paclitaxel chemotherapy with either a standard diet or a fasting mimicking diet (FMD) for 6-10 cycles, each cycle lasting 3 weeks

18-30 weeks

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Fasting Mimicking Diet (FMD)
• Paclitaxel

Trial Overview The study examines if combining a Fasting Mimicking Diet (FMD) with standard chemotherapy drugs Paclitaxel and Carboplatin reduces toxicity and improves tumor response in patients compared to those on a regular diet during treatment. The FMD product used is Xentigen by L'Nutra.

How Is the Trial Designed?

Group I: Carboplatin and paclitaxel with fasting mimicking diet (FMD) Experimental Treatment 3 Interventions

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6-10 cycles in the absence of disease progression or unacceptable toxicity. A fasting mimicking diet (FMD) is consumed beginning 3 days prior to chemotherapy and on the day of chemotherapy (days -2, -1, 0 and 1 of each cycle).

Group II: Carboplatin and paclitaxel with standard diet Active Control 3 Interventions

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6-10 cycles in the absence of disease progression or unacceptable toxicity. A standard diet is consumed throughout each cycle of therapy.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

L-Nutra Inc

Industry Sponsor

Trials

10

Recruited

730+

Published Research Related to This Trial

Patients with ovarian cancer who relapse more than 6 months after platinum-based chemotherapy can benefit from repeat chemotherapy with carboplatin, especially when combined with paclitaxel, which showed a 7% increase in survival and a 10% increase in progression-free survival in a trial of 802 patients.

The combination treatment resulted in higher rates of certain side effects, such as significant hair loss and neurotoxicity, indicating that while the combination is more effective, it also comes with increased toxicity compared to carboplatin alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of platinum-sensitive relapsed ovarian cancer, with particular reference to the International Collaboration in Ovarian Neoplasm-4/Arbeitsgemeinschaft Gynakologische Onkologie Ovarian Cancer-2.2 trial. Kaye, SB.[2018]

In a phase II trial involving 53 women with stage IV ovarian cancer, a novel treatment strategy combining modified chemotherapy and maintenance therapy with paclitaxel resulted in a 2-year overall survival rate of 48%, which is lower than the 60% survival rate of a historical control group treated with standard therapy.

The study highlighted the feasibility of adjusting treatment based on patient response, but ultimately concluded that this specific approach does not warrant further investigation due to its survival outcomes not being superior to existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of single agent carboplatin followed by dose-intense paclitaxel, followed by maintenance paclitaxel therapy in stage IV ovarian, fallopian tube, and peritoneal cancers: a Southwest Oncology Group trial. Markman, M., Glass, T., Smith, HO., et al.[2019]

The combination of carboplatin and 3-hour infusional paclitaxel was well-tolerated in a study of 92 women with advanced gynecologic cancers, showing a manageable toxicity profile with neutropenia being the most significant side effect.

In patients with ovarian cancer or primary peritoneal carcinoma, 74% experienced a significant decline in tumor marker levels after treatment, indicating strong antineoplastic activity of this chemotherapy regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin plus paclitaxel in the treatment of gynecologic malignancies: the Cleveland Clinic experience. Markman, M., Kennedy, A., Webster, K., et al.[2015]

In a study of 49 patients with advanced epithelial ovarian cancer receiving adjuvant intraperitoneal carboplatin and intravenous dose-dense paclitaxel, the treatment was well-tolerated, with 87.8% completing six cycles of chemotherapy.

The side effects observed, such as neutropenia (32.7%) and the need for red blood cell transfusions (28.6%), were comparable to or better than those reported in traditional treatment regimens, indicating a favorable safety profile for this chemotherapy approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Tolerance and Side Effects of Intraperitoneal Carboplatin and Dose-Dense Intravenous Paclitaxel in Ovarian Cancer. Bisch, SP., Sugimoto, A., Prefontaine, M., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05921149

Fasting Mimicking Diet (FMD) in Conjunction With ... This trial tests whether platinum-taxane chemotherapy combined with a FMD in advanced and recurrent ovarian, fallopian tube and primary peritoneal cancer ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06376604

Study Details | NCT06376604 | Fasting Mimicking Diet in ... Our hypothesis is that a fasting mimicking diet will significantly decrease chemotherapy-related side effects while providing good quality of life.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10037739/

Short-term fasting and fasting mimicking diets combined ... In this narrative review, we identify and describe the current evidence about feasibility and effects of STF and FMDs in cancer patients receiving chemotherapy.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006295223002903

Verification of fasting-mimicking diet to assist monotherapy ... Based on these findings, FMD might be a safe and effective auxiliary approach and be worthy of being further investigated to assist nanodrug in cancer therapy.

5. withpower.com withpower.com/trial/phase-deficiency-calorie-8-2021-6c0f9

Fasting Mimicking Diet for Ovarian Cancer Fasting or a fasting-mimicking diet (FMD) can slow down tumor growth but does not enhance the sensitivity of colorectal cancer (CRC) cells to chemotherapy drugs ...

6. clinicaltrial.be clinicaltrial.be/en/details/272036?per_page=100&only_recruiting=0&only_eligible=0

Fasting Mimicking Diet (FMD) in Conjunction With ... Rates of grade 3-4 toxicity with carboplatin and paclitaxel chemotherapy range 26-84%. Interventions to reduce toxicity are needed.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8391327/

Safety and Feasibility of Fasting-Mimicking Diet and Effects ... FMD was largely safe with only mild side effects. The patients' weight and handgrip remained stable, the phase angle and fat-free mass increased ...

8. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/470881

Fasting Mimicking Diet (FMD) in Conjunction With ... Rates of grade 3-4 toxicity with carboplatin and paclitaxel chemotherapy range 26-84%. Interventions to reduce toxicity are needed. Short term fasting ...

9. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05921149/fasting-mimicking-diet-fmd-in-conjunction-with-chemotherapy-in-advanced-ovarian-cancer?activelyRecruiting=false&page=381&id=423&slug=chemotherapy

Fasting Mimicking Diet (FMD) in Conjunction With ... Rates of grade 3-4 toxicity with carboplatin and paclitaxel chemotherapy range 26-84%. Interventions to reduce toxicity are needed.