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NCT Number: NCT05921149

Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer

Rates of grade 3-4 toxicity with carboplatin and paclitaxel chemotherapy range 26-84%. Interventions to reduce toxicity are needed.

Short term fasting protects against toxic effects of chemotherapy without decreasing efficacy. In a prospective clinical trial of breast cancer patients randomized to FMD or regular diet during chemotherapy, less antiemetic was required in the FMD group; radiographic and pathologic responses were better in this group.

This trial tests whether platinum-taxane chemotherapy combined with a FMD in advanced and recurrent ovarian, fallopian tube and primary peritoneal cancer patients is associated with decreased toxicity and/ or improved tumor response to therapy.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Chemotherapeutic Toxicity Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location contact

Mary T Jenkins Vogel, MD

PRINCIPAL_INVESTIGATOR

Michele Britto, RN

CONTACT

[email protected]

847-570-2109

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • All patients with advanced ovarian, fallopian tube and primary peritoneal carcinomas deemed appropriate candidates for neoadjuvant chemotherapy and patients with recurrent, platinum-sensitive disease (as defined by an interval of at least 6 months following completion of last platinum-based chemotherapy prior to disease relapse or progression)
  • ECOG Performance Status of 0, 1 or 2.
  • Adequate bone marrow reserve (absolute neutrophil count (ANC) ≥1.5 x 109/L and platelet count ≥100 x 109/L).
  • Adequate renal function defined as creatinine ≤1.5 x laboratory upper limit of normal (ULN).
  • Adequate hepatic function defined as:

Bilirubin ≤1.5 x ULN ALT and AST ≤3 x ULN

  • BMI ≥19 kg/m2

Exclusion criteria

  • Patients with malnutrition and/ or BMI <19
  • Patients with active eating disorders (as identified by history of pre-enrollment nutrition screen)
  • Diabetes mellitus requiring medication management (both insulin and non-insulin requiring). Patients with diabetes mellitus controlled by diet alone (i.e. patients not requiring anti-glycemic medications) are NOT excluded and are eligible for participation.
  • Allergy to component of fasting mimicking diet (FMD)
  • 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)

Treatment and study plan

Fasting Mimicking Diet (Xentigen by L'Nutra)

Dietary Supplement

L-Nutra Xentigen is a product which will provide all the food to be consumed by subjects during 3 days prior to chemotherapy and for 24 hours after chemotherapy. Xentigen is a plant-based diet program designed to attain fasting-like effects while providing both macro- and micronutrients to minimize the burden of fasting and adverse effects. The FMD consists of 100% ingredients that are generally regarded as safe (GRAS) and comprises proprietary vegetable-based soups and broths, energy bars, energy drinks, cracker snacks, herbal teas, and supplements. The FMD consists of a 4-day regimen that provides approximately 1100 kilocalories for the first day and approximately 500 kilocalories per day for the second to the fourth day. Subsequently, a day 5 of transition diet (approximately 800 kilocalories) is provided to avoid the refeeding syndrome.

carboplatin

Drug

Given IV

paclitaxel

Drug

Given IV

Standard diet

Dietary Supplement

Normal diet

Primary outcomes

  1. 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.

    Time frame: 6 months

    Toxicities and adverse events will be graded and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), v5.0 and will be compared between the two study groups. The following toxicity summaries will be used to compare the diet and non-diet group:

    Any of the following Grade 2+ GI symptomatic toxicities (nausea and vomiting, anorexia, constipation or diarrhea, mucositis, stomatitis) experienced.

    The NCI CTCAE has a specific scale (graded 1-5) for each toxicity which can be used objectively to compare different drug toxicities.

  2. 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.

    Time frame: 6 months

    Toxicities and adverse events will be graded and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), v5.0 and will be compared between the two study groups. The following toxicity summaries will be used to compare the diet and non-diet group:

    Any Grade 2+ neuropathy experienced. The NCI CTCAE has a specific scale (graded 1-5) for each toxicity which can be used objectively to compare different drug toxicities.

  3. 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.

    Time frame: 6 months

    Toxicities and adverse events will be graded and summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), v5.0 and will be compared between the two study groups. The following toxicity summaries will be used to compare the diet and non-diet group:

    Any Grade 3+ hematologic toxicity experienced. The NCI CTCAE has a specific scale (graded 1-5) for each toxicity which can be used objectively to compare different drug toxicities.

  4. To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with improved quality of life (QOL) in advanced and recurrent ovarian cancer patients

    Time frame: 6 months

    The primary QOL question examines whether chemotherapy plus FMD is associated with improved physical function and reduced chemotherapy-related side effects/ symptoms compared to chemotherapy administered with a regular diet. QOL and side effects/ symptoms of chemotherapy will be recorded using the Functional Assessment of Cancer Therapy (FACT) ovarian cancer questionnaire and compared between the study groups.

  5. To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with improved QOL specifically with regards to less neuropathy in advanced and recurrent ovarian cancer patients

    Time frame: 6 months

    This specific QOL question examines whether chemotherapy plus FMD is associated with improved physical function and reduced chemotherapy-related neuropathy compared to chemotherapy administered with a regular diet. QOL as impacted by neuropathy, specifically will be recorded using the FACT/ Gynecologic Oncology Group (GOG)-Neurotoxicity (Ntx) 4-item subscale and compared between the two study groups.

  6. To determine whether the combination of standard of care platinum-taxane chemotherapy with a FMD compared to a regular diet is associated with improved QOL specifically with regards to less fatigue in advanced and recurrent ovarian cancer patients

    Time frame: 6 months

    This specific QOL question examines whether chemotherapy plus FMD is associated with improved physical function and reduced fatigue compared to chemotherapy administered with a regular diet. QOL as impacted by fatigue, specifically, will be assessed using the 7-item Patient Reported Outcomes Measurement Information System (PROMIS) fatigue short form and compared between the two study groups.

Secondary outcomes

  1. To describe the safety and tolerability of a concurrent FMD, including patient compliance to diet, with platinum-taxane chemotherapy in advanced and recurrent ovarian cancer patients.

    Time frame: 6 months

    Safety will be assessed by measuring and comparing adverse events experienced by patients in each study group. This study will utilize the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 to describe and quantify study subject adverse events. In addition the number of patients that do not complete the FMD during chemotherapy will be recorded. The number of cycles completed with the FMD for each patient in the FMD group will be recorded to determine compliance with the regimen.

  2. 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.

    Time frame: 6 months

    Tumor response will be measured radiographically via RECIST 1.1.

  3. 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.

    Time frame: 6 months

    Tumor response based on change in serum biomarker will be measured using CA 125 blood levels.

  4. 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.

    Time frame: 6 months

    Tumor pathologic response in the primary (neoadjuvant) treatment group will be measured using a 3-tier chemotherapy response score (CRS). CRS is assigned on a scale of 1-3 with 3 representing the most complete response to treatment (ie best response) and 1 representing the least robust response to treatment (ie worst response).

  5. To measure the progression free survival (PFS) at 2 and 5 years in each group.

    Time frame: 2 and 5 years

  6. To measure the overall survival (OS) in each group.

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Michele Britto, RN

CONTACT

[email protected]

(847) 570-2109

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

  • L-Nutra Inc

Registry information

Official study title

A Randomized Controlled Study of a Fasting Mimicking Diet (FMD) in Conjunction With Combination Carboplatin and Paclitaxel in the Treatment of Patients With Advanced or Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Important dates

Study start
2024
Primary completion
2028
Study completion
2031
First posted
Jun 27, 2023
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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