Back to resultsFasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer
Primary Purpose
Ovarian Cancer, Chemotherapeutic Toxicity
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fasting Mimicking Diet (Xentigen by L'Nutra)
Carboplatin
Paclitaxel
Standard diet
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
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)
Sites / Locations
- NorthShore University HealthSystem
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Carboplatin and paclitaxel with standard diet
Carboplatin and paclitaxel with fasting mimicking diet (FMD)
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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
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.
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
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.
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
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 Outcome Measures
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.
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.
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.
Tumor response will be measured radiographically via RECIST 1.1.
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.
Tumor response based on change in serum biomarker will be measured using CA 125 blood levels.
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.
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).
To measure the progression free survival (PFS) at 2 and 5 years in each group.
To measure the overall survival (OS) in each group.
Full Information
NCT ID
NCT05921149
First Posted
April 23, 2023
Last Updated
October 15, 2023
Sponsor
NorthShore University HealthSystem
Collaborators
L-Nutra Inc
1. Study Identification
Unique Protocol Identification Number
NCT05921149
Brief Title
Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2028 (Anticipated)
Study Completion Date
June 1, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem
Collaborators
L-Nutra Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Chemotherapeutic Toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Carboplatin and paclitaxel with standard diet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Carboplatin and paclitaxel with fasting mimicking diet (FMD)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Fasting Mimicking Diet (Xentigen by L'Nutra)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Given IV
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard diet
Intervention Description
Normal diet
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 months
Title
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.
Description
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.
Time Frame
6 months
Title
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.
Description
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.
Time Frame
6 months
Title
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
Description
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.
Time Frame
6 months
Title
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
Description
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.
Time Frame
6 months
Title
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
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 months
Title
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.
Description
Tumor response will be measured radiographically via RECIST 1.1.
Time Frame
6 months
Title
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.
Description
Tumor response based on change in serum biomarker will be measured using CA 125 blood levels.
Time Frame
6 months
Title
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.
Description
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).
Time Frame
6 months
Title
To measure the progression free survival (PFS) at 2 and 5 years in each group.
Time Frame
2 and 5 years
Title
To measure the overall survival (OS) in each group.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Britto, RN
Phone
(847) 570-2109
Email
mbritto@northshore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary T Jenkins Vogel, MD
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Britto, RN
Phone
847-570-2109
Email
mbritto@northshore.org
First Name & Middle Initial & Last Name & Degree
Mary T Jenkins Vogel, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31113478
Citation
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Citation
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Citation
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Results Reference
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Citation
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Citation
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Citation
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Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer
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