What side effects are associated with this type of intervention?

The most common treatments for ovarian cancer, such as carboplatin and paclitaxel chemotherapy, are associated with a range of side effects. These include severe neutropenia, thrombocytopenia, and neuropathy. Additionally, patients often experience gastrointestinal issues like nausea, vomiting, and diarrhea. Hand-foot syndrome and stomatitis are also reported. The Fasting-Mimicking Diet (FMD) is being studied for its potential to reduce these toxic effects while maintaining the efficacy of the chemotherapy.

What prior FDA approvals exist?

The FDA has approved several treatments for ovarian cancer that are similar to those being studied in the Fasting-Mimicking Diet (FMD) trial. These include the combination of carboplatin and paclitaxel, which is a standard first-line chemotherapy regimen for advanced ovarian cancer. Additionally, bevacizumab, an angiogenesis inhibitor, has been approved for use in combination with platinum-based chemotherapy and as a maintenance therapy. PARP inhibitors such as olaparib, niraparib, and rucaparib have also been approved for maintenance therapy in patients with recurrent ovarian cancer, particularly those with BRCA mutations or homologous recombination deficiency (HRD). These treatments aim to improve progression-free survival and, in some cases, overall survival, while managing the toxicity associated with chemotherapy.

What other types of research exist?

One promising alternative to Fasting-Mimicking Diet (FMD) for ovarian cancer patients is the use of calmangafodipir (PledOx®). This compound mimics the mitochondrial enzyme manganese superoxide dismutase, protecting cells from oxidative stress and has shown potential in preventing oxaliplatin-induced peripheral neuropathy in metastatic colorectal cancer patients. Another potential alternative is the methionine-restricted (MR) diet, which has shown partial responses and disease stabilization in metastatic colorectal cancer patients when combined with chemotherapy. Both interventions could be considered for their potential to reduce chemotherapy toxicity and improve tumor response.

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Chemotherapy

Fasting Mimicking Diet + Chemotherapy for Ovarian Cancer

N/A

Waitlist Available

Led By Mary T Jenkins Vogel, MD

Research Sponsored by NorthShore University HealthSystem

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate renal function defined as creatinine ≤1.5 x laboratory upper limit of normal (ULN)

Age ≥ 18 years

Must not have

Patients with recurrent ovarian, fallopian tube and primary peritoneal carcinomas with relapse within 6 months of completion of last platinum-based chemotherapy regimen (i.e. patients with platinum-resistant disease)

Diabetes mellitus requiring medication management (both insulin and non-insulin requiring)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Chemotherapy can cause severe side effects like fatigue, nausea/vomiting, low blood cell counts leading to infection risk or bleeding problems. The FMD aims to reduce these without affecting the cancer-fighting benefits of chemo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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My blood tests show enough white blood cells and platelets.

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

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My liver tests are within the normal range.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My ovarian, fallopian tube, or peritoneal cancer returned within 6 months after my last platinum-based treatment.

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I am taking medication for diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with decreased gastrointestinal (GI) toxicity in advanced and recurrent ovarian cancer patients.

To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with decreased hematologic toxicity in advanced and recurrent ovarian cancer patients.

To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with decreased neurotoxicity in advanced and recurrent ovarian cancer patients.

+3 more

Secondary study objectives

To compare radiographic tumor response to therapy in advanced and recurrent ovarian cancer patients treated with the combination of platinum-taxane chemotherapy and a FMD versus a regular diet.

To compare tumor pathologic response to therapy in advanced ovarian cancer patients treated with the combination of platinum-taxane chemotherapy and a FMD versus a regular diet.

To compare tumor response to therapy using a serum biomarker in advanced and recurrent ovarian cancer patients treated with the combination of platinum-taxane chemotherapy and a FMD versus a regular diet.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Carboplatin and paclitaxel with fasting mimicking diet (FMD)Experimental Treatment3 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 dietActive Control3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5370

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include chemotherapy agents such as carboplatin and paclitaxel. Carboplatin works by causing DNA damage that leads to cancer cell death, while paclitaxel stabilizes microtubules, preventing cell division. The Fasting-Mimicking Diet (FMD) is being studied for its potential to reduce the toxicity of these chemotherapies and improve tumor response. FMD may protect normal cells from the harmful effects of chemotherapy while making cancer cells more susceptible to treatment. This is crucial for ovarian cancer patients as it could enhance the effectiveness of chemotherapy and reduce side effects, improving overall treatment outcomes.

Amentoflavone suppresses tumor growth in ovarian cancer by modulating Skp2.