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

170 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Fasting Mimicking Diet + Chemotherapy for Ovarian Cancer?

Research shows that using paclitaxel and carboplatin weekly can improve survival in ovarian cancer patients compared to the standard three-week schedule. This suggests that the chemotherapy part of the treatment may be effective in improving outcomes for ovarian cancer. ^{1 2 3 4 5}

Is the combination of carboplatin and paclitaxel generally safe for treating ovarian cancer?

The combination of carboplatin and paclitaxel is generally considered safe for treating ovarian cancer, with common side effects including neutropenia (low white blood cell count), anemia (low red blood cell count), and peripheral neuropathy (nerve damage). Some patients may experience hypersensitivity reactions, but these are usually manageable, allowing treatment to continue. ^{4 6 7 8 9}

What makes the Fasting Mimicking Diet combined with Carboplatin and Paclitaxel unique for treating ovarian cancer?

This treatment is unique because it combines a Fasting Mimicking Diet, which may enhance the effectiveness of chemotherapy, with the standard drugs Carboplatin and Paclitaxel, potentially improving outcomes by reducing side effects and increasing cancer cell sensitivity to the drugs. ^{3 10 11 12 13}

What is the purpose of this trial?

This trial tests whether a special diet that mimics fasting can help reduce the severe side effects of chemotherapy in patients with advanced ovarian, fallopian tube, and primary peritoneal cancer. The diet aims to protect the body while still allowing the chemotherapy to work effectively. Previous studies have shown that this diet can reduce nausea and improve treatment outcomes.

Research Team

Mary T Jenkins Vogel, MD

Principal Investigator

Endeavor Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Improved outcomes with dose-dense paclitaxel-based neoadjuvant chemotherapy in advanced epithelial ovarian carcinoma. [2019]

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

Long-term results of a randomised phase III trial of weekly versus three-weekly paclitaxel/platinum induction therapy followed by standard or extended three-weekly paclitaxel/platinum in European patients with advanced epithelial ovarian cancer. [2015]

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

Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomised, multicentre, open-label, phase 3 trial. [2022]

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

Taxane/platinum/anthracycline combination therapy in advanced epithelial ovarian cancer. [2015]

5. United States 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. [2019]

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

Carboplatin plus paclitaxel in the treatment of gynecologic malignancies: the Cleveland Clinic experience. [2015]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment Tolerance and Side Effects of Intraperitoneal Carboplatin and Dose-Dense Intravenous Paclitaxel in Ovarian Cancer. [2019]

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

Extended weekly dose-dense paclitaxel/carboplatin is feasible and active in heavily pre-treated platinum-resistant recurrent ovarian cancer. [2021]

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

In vitro analysis of ovarian cancer response to cisplatin, carboplatin, and paclitaxel identifies common pathways that are also associated with overall patient survival. [2021]

10. England 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. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Consolidation and maintenance treatments for patients with advanced epithelial ovarian cancer in complete response after first-line chemotherapy: a review of the literature. [2015]

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

Paclitaxel/carboplatin for the initial treatment of advanced ovarian cancer. [2015]

13. Japan pubmed.ncbi.nlm.nih.gov

[Practical use of taxol-based chemotherapy for poor compliance gynecologic cancers in Japanese woman]. [2015]