Cancer, OvarianNCT06376604
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies
A study testing Fasting Mimicking Diet and Chemotherapy in people with Cancer, Ovarian and Chemotherapy Effect, run by L-Nutra Inc at 1 site in United States.
Trial summary
This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Cancer, Ovarian, Chemotherapy Effect, Calorie Deficiency
- What is being tested?
- Fasting Mimicking Diet and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Age 35-70 years old (both inclusive)
- Biopsy proven gynecologic malignancy
- Scheduled to or currently undergoing chemotherapy, with a minimum of 6 cycles remaining
- BMI greater than or equal to 18.5
- Adequate renal function (serum creatinine less than 1.5 times the upper limit of normal)
- Willing to adhere to a 5-day fasting mimicking diet
Who cannot join
- Pregnant or nursing mothers
- Prisoners
- Patients with diabetes or history of hypoglycemia
- Taking daily medications that cannot be safely taken without food
- History of significant or unstable cardiac disease such as congestive heart failure or history of myocardial infarction, stroke or pulmonary embolism within the last 3 months, renal failure, history of - eating disorder, dementia, psychosis, impaired physical mobility.
- Significant medical comorbidity that would be dangerous with a fasting mimicking diet.
- Any known or suspected food allergies that overlap with the FMD/Transitional diet by L-Nutra meal kit ingredients.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Jonathan D Boone, MD, 865-305-5622, jboone@utmck.edu
About this study
Official title: Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies
This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.
Read the detailed description
Since chemotherapy remains one of the primary treatment modalities for gynecologic malignancies, there is increasing interest in non-pharmacological methods of reducing chemotherapy side effects in cancer patients. Our goal is to increase the knowledge surrounding lifestyle modifications, specifically the fasting mimicking diet, on chemotherapy-related side effects, which may be more acceptable to patients than a previously studied water-only fasting diet. To expand this knowledge, The investigators will focus on patients undergoing chemotherapy for gynecologic malignancies. These patients will be assigned to no dietary restriction (control group) or a 5-day fasting mimicking diet (FMD by L-Nutra) for three days prior to, the day of, and one day following chemotherapy treatments (treatment group). The investigators aim to evaluate the feasibility of a fasting mimicking diet in addition to its metabolic effects on the body, patient reported side effects, patient quality of life, deviations or delays in treatment plans, and hospital admissions. Our hypothesis is that a fasting mimicking diet will significantly decrease chemotherapy-related side effects while providing good quality of life.
- Being tested
- Fasting Mimicking Diet, Chemotherapy
- Keywords
- Fasting mimicking diet, Gynecologic malignancy, Chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting Mimicking DietOther
Subject will consume 6 cycles of 5-day fasting mimicking diet: 3 days prior to, the day of, and 1 day following chemotherapy treatments.
ChemotherapyDrug
6 cycles of standard chemotherapy for the gynecologic malignancy.
| Study group | Role | What they receive |
|---|---|---|
| FMD | Experimental | In addition to the standard care, subject will consume a 5-day fasting mimicking diet. Receives: Other: Fasting Mimicking Diet; Drug: Chemotherapy |
| Control | Active comparator | Subjects will receive the standard care and no dietary changes. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire
The NFOSI-18 questionnaire allows for a uniform assessment of health-related quality of life through an 18-question (5-point Likert-type scale) survey including four subscale domains: Disease-Related Symptoms - Physical, Disease-Related Symptoms - Emotional, Treatment Side Effects. and Function/Well-Being. To calculate subscale scores, sum the item scores within each domain. Higher subscale scores indicate more significant symptom burden or impact. The total score is obtained by summing all 18 item scores. A higher total score reflects more severe symptoms overall.
Measured: Week 0-21
Rate of Adherence
The ability to adhere to a 5-day fasting mimicking diet.
Measured: Week 0-21
Secondary outcomes (11)
Change in Body Weight
Change in body weight.
Measured: Week 0, Week12, Week 21
Change in Body Composition
Changes in weight, skeletal muscle mass, body fat percentage by the Inbody(R) Body Composition Analyzer.
Measured: Week 0, Week12, Week 21
Change in HbA1c
Change in blood HbA1c.
Measured: Week 0, Week 21
Change in Insulin Like Growth Factor 1 (IGF-1) Concentration
Change in blood insulin like growth factor 1 level.
Measured: Week 0, Week 21
Change in Fasting Insulin Concentration
Change in fasting insulin level.
Measured: Week 0, Week 21
Change in Fasting Glucose Concentration
Change in fasting glucose level.
Measured: Week 0, Week 21
Change in High-sensitivity C reactive protein Concentration
Change in blood C reactive protein level.
Measured: Week 0, Week 21
Change in Leptin Concentration
Change in blood leptin level.
Measured: Week 0, Week 21
Change in planned chemotherapy regimen
Deviation from the planned chemotherapy regimen.
Measured: Week 0-21
Number of Hospitalization Days
Days of hospitalization
Measured: Week 0-21
Rate of Chemotherapy Side Effects
Rate of Adverse effects associated with chemotherapy
Measured: Week 0-21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start8 Sep 2021
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cancer, OvarianStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L-Nutra Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Tennessee Medical Center
- Responsible party
- Sponsor
- Investigators
- Jonathan D Boone, Principal investigator, The University of Tennessee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376604
- Sponsor's protocol ID
- LNT55
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caffa I, Spagnolo V, Vernieri C, Valdemarin F, Becherini P, Wei M, Brandhorst S, Zucal C, Driehuis E, Ferrando L, Piacente F, Tagliafico A, Cilli M, Mastracci L, Vellone VG, Piazza S, Cremonini AL, Gradaschi R, Mantero C, Passalacqua M, Ballestrero A, Zoppoli G, Cea M, Arrighi A, Odetti P, Monacelli F, Salvadori G, Cortellino S, Clevers H, De Braud F, Sukkar SG, Provenzani A, Longo VD, Nencioni A. Fasting-mimicking diet and hormone therapy induce breast cancer regression. Nature. 2020 Jul;583(7817):620-624. doi: 10.1038/s41586-020-2502-7. Epub 2020 Jul 15.
PubMed 32669709de Groot S, Lugtenberg RT, Cohen D, Welters MJP, Ehsan I, Vreeswijk MPG, Smit VTHBM, de Graaf H, Heijns JB, Portielje JEA, van de Wouw AJ, Imholz ALT, Kessels LW, Vrijaldenhoven S, Baars A, Kranenbarg EM, Carpentier MD, Putter H, van der Hoeven JJM, Nortier JWR, Longo VD, Pijl H, Kroep JR; Dutch Breast Cancer Research Group (BOOG). Fasting mimicking diet as an adjunct to neoadjuvant chemotherapy for breast cancer in the multicentre randomized phase 2 DIRECT trial. Nat Commun. 2020 Jun 23;11(1):3083. doi: 10.1038/s41467-020-16138-3.
PubMed 32576828Finnell JS, Saul BC, Goldhamer AC, Myers TR. Is fasting safe? A chart review of adverse events during medically supervised, water-only fasting. BMC Complement Altern Med. 2018 Feb 20;18(1):67. doi: 10.1186/s12906-018-2136-6.
PubMed 29458369Goncalves MD, Cantley LC. A 'fast'er way to treat breast cancer. Nat Metab. 2020 Jul;2(7):559-560. doi: 10.1038/s42255-020-0225-6. No abstract available.
PubMed 32694797Lee C, Raffaghello L, Brandhorst S, Safdie FM, Bianchi G, Martin-Montalvo A, Pistoia V, Wei M, Hwang S, Merlino A, Emionite L, de Cabo R, Longo VD. Fasting cycles retard growth of tumors and sensitize a range of cancer cell types to chemotherapy. Sci Transl Med. 2012 Mar 7;4(124):124ra27. doi: 10.1126/scitranslmed.3003293. Epub 2012 Feb 8.
PubMed 22323820Raffaghello L, Safdie F, Bianchi G, Dorff T, Fontana L, Longo VD. Fasting and differential chemotherapy protection in patients. Cell Cycle. 2010 Nov 15;9(22):4474-6. doi: 10.4161/cc.9.22.13954. Epub 2010 Nov 15.
PubMed 21088487Safdie FM, Dorff T, Quinn D, Fontana L, Wei M, Lee C, Cohen P, Longo VD. Fasting and cancer treatment in humans: A case series report. Aging (Albany NY). 2009 Dec 31;1(12):988-1007. doi: 10.18632/aging.100114.
PubMed 20157582Moss HA, Havrilesky LJ. The use of patient-reported outcome tools in Gynecologic Oncology research, clinical practice, and value-based care. Gynecol Oncol. 2018 Jan;148(1):12-18. doi: 10.1016/j.ygyno.2017.11.011. Epub 2017 Nov 23.
PubMed 29174565
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT06376604
- Acronym / sponsor ID
- LNT55
- Keywords
- Fasting mimicking diet, Gynecologic malignancy, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- L-Nutra IncIndustry (pharma, biotech, devices)
- Collaborators
- University of Tennessee Medical Center
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.
Detailed description
Since chemotherapy remains one of the primary treatment modalities for gynecologic malignancies, there is increasing interest in non-pharmacological methods of reducing chemotherapy side effects in cancer patients. Our goal is to increase the knowledge surrounding lifestyle modifications, specifically the fasting mimicking diet, on chemotherapy-related side effects, which may be more acceptable to patients than a previously studied water-only fasting diet. To expand this knowledge, The investigators will focus on patients undergoing chemotherapy for gynecologic malignancies. These patients will be assigned to no dietary restriction (control group) or a 5-day fasting mimicking diet (FMD by L-Nutra) for three days prior to, the day of, and one day following chemotherapy treatments (treatment group). The investigators aim to evaluate the feasibility of a fasting mimicking diet in addition to its metabolic effects on the body, patient reported side effects, patient quality of life, deviations or delays in treatment plans, and hospital admissions. Our hypothesis is that a fasting mimicking diet will significantly decrease chemotherapy-related side effects while providing good quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMD | Experimental | Other: Fasting Mimicking Diet, Drug: ChemotherapyIn addition to the standard care, subject will consume a 5-day fasting mimicking diet. |
| Control | Active comparator | Drug: ChemotherapySubjects will receive the standard care and no dietary changes. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women
- Age 35-70 years old (both inclusive)
- Biopsy proven gynecologic malignancy
- Scheduled to or currently undergoing chemotherapy, with a minimum of 6 cycles remaining
- BMI greater than or equal to 18.5
Key exclusion criteria (7 listed)
- Pregnant or nursing mothers
- Prisoners
- Patients with diabetes or history of hypoglycemia
- Taking daily medications that cannot be safely taken without food
- History of significant or unstable cardiac disease such as congestive heart failure or history of myocardial infarction, stroke or pulmonary embolism within the last 3 months, renal failure, history of - eating disorder, dementia, psychosis, impaired physical mobility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting Mimicking DietSubject will consume 6 cycles of 5-day fasting mimicking diet: 3 days prior to, the day of, and 1 day following chemotherapy treatments. | Other | FMD |
| Chemotherapy6 cycles of standard chemotherapy for the gynecologic malignancy. | Drug | Control, FMD |
Primary outcome
Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire
Time frame: Week 0-21
The NFOSI-18 questionnaire allows for a uniform assessment of health-related quality of life through an 18-question (5-point Likert-type scale) survey including four subscale domains: Disease-Related Symptoms - Physical, Disease-Related Symptoms - Emotional, Treatment Side Effects. and Function/Well-Being. To calculate subscale scores, sum the item scores within each domain. Higher subscale scores indicate more significant symptom burden or impact. The total score is obtained by summing all 18 item scores. A higher total score reflects more severe symptoms overall.
Rate of Adherence
Time frame: Week 0-21
The ability to adhere to a 5-day fasting mimicking diet.
11 secondary outcomes
Change in Body Weight
Time frame: Week 0, Week12, Week 21
Change in Body Composition
Time frame: Week 0, Week12, Week 21
Change in HbA1c
Time frame: Week 0, Week 21
Change in Insulin Like Growth Factor 1 (IGF-1) Concentration
Time frame: Week 0, Week 21
Change in Fasting Insulin Concentration
Time frame: Week 0, Week 21
Change in Fasting Glucose Concentration
Time frame: Week 0, Week 21
Change in High-sensitivity C reactive protein Concentration
Time frame: Week 0, Week 21
Change in Leptin Concentration
Time frame: Week 0, Week 21
Change in planned chemotherapy regimen
Time frame: Week 0-21
Number of Hospitalization Days
Time frame: Week 0-21
Rate of Chemotherapy Side Effects
Time frame: Week 0-21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 32669709Caffa I, Spagnolo V, Vernieri C, Valdemarin F, Becherini P, Wei M, Brandhorst S, Zucal C, Driehuis E, Ferrando L, Piacente F, Tagliafico A, Cilli M, Mastracci L, Vellone VG, Piazza S, Cremonini AL, Gradaschi R, Mantero C, Passalacqua M, Ballestrero A, Zoppoli G, Cea M, Arrighi A, Odetti P, Monacelli F, Salvadori G, Cortellino S, Clevers H, De Braud F, Sukkar SG, Provenzani A, Longo VD, Nencioni A. Fasting-mimicking diet and hormone therapy induce breast cancer regression. Nature. 2020 Jul;583(7817):620-624. doi: 10.1038/s41586-020-2502-7. Epub 2020 Jul 15.
- Background: PubMed 32576828de Groot S, Lugtenberg RT, Cohen D, Welters MJP, Ehsan I, Vreeswijk MPG, Smit VTHBM, de Graaf H, Heijns JB, Portielje JEA, van de Wouw AJ, Imholz ALT, Kessels LW, Vrijaldenhoven S, Baars A, Kranenbarg EM, Carpentier MD, Putter H, van der Hoeven JJM, Nortier JWR, Longo VD, Pijl H, Kroep JR; Dutch Breast Cancer Research Group (BOOG). Fasting mimicking diet as an adjunct to neoadjuvant chemotherapy for breast cancer in the multicentre randomized phase 2 DIRECT trial. Nat Commun. 2020 Jun 23;11(1):3083. doi: 10.1038/s41467-020-16138-3.
- Background: PubMed 29458369Finnell JS, Saul BC, Goldhamer AC, Myers TR. Is fasting safe? A chart review of adverse events during medically supervised, water-only fasting. BMC Complement Altern Med. 2018 Feb 20;18(1):67. doi: 10.1186/s12906-018-2136-6.
- Background: PubMed 32694797Goncalves MD, Cantley LC. A 'fast'er way to treat breast cancer. Nat Metab. 2020 Jul;2(7):559-560. doi: 10.1038/s42255-020-0225-6. No abstract available.
- Background: PubMed 22323820Lee C, Raffaghello L, Brandhorst S, Safdie FM, Bianchi G, Martin-Montalvo A, Pistoia V, Wei M, Hwang S, Merlino A, Emionite L, de Cabo R, Longo VD. Fasting cycles retard growth of tumors and sensitize a range of cancer cell types to chemotherapy. Sci Transl Med. 2012 Mar 7;4(124):124ra27. doi: 10.1126/scitranslmed.3003293. Epub 2012 Feb 8.
- Background: PubMed 21088487Raffaghello L, Safdie F, Bianchi G, Dorff T, Fontana L, Longo VD. Fasting and differential chemotherapy protection in patients. Cell Cycle. 2010 Nov 15;9(22):4474-6. doi: 10.4161/cc.9.22.13954. Epub 2010 Nov 15.
- Background: PubMed 20157582Safdie FM, Dorff T, Quinn D, Fontana L, Wei M, Lee C, Cohen P, Longo VD. Fasting and cancer treatment in humans: A case series report. Aging (Albany NY). 2009 Dec 31;1(12):988-1007. doi: 10.18632/aging.100114.
- Background: PubMed 29174565Moss HA, Havrilesky LJ. The use of patient-reported outcome tools in Gynecologic Oncology research, clinical practice, and value-based care. Gynecol Oncol. 2018 Jan;148(1):12-18. doi: 10.1016/j.ygyno.2017.11.011. Epub 2017 Nov 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan D Boone principal investigator
The University of Tennessee Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting Mimicking Diet and Chemotherapy in people with Cancer, Ovarian and Chemotherapy Effect, run by L-Nutra Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Wei, PhD (323.791.2426, mwei@l-nutra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire (time frame: Week 0-21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06376604, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.