Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

Chemotherapy Effect Clinical Trial

Official title:

Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06376604
• Other study ID #: LNT55
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2024
• Source: L-Nutra Inc
• Contact: Min Wei, PhD
• Phone: 323.791.2426
• Email: mwei[@]l-nutra.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Calorie Deficiency
• Cancer, Ovarian
• Chemotherapy Effect
• Fasting, Intermittent
• Neoplasms
• Ovarian Neoplasms

Intervention

Other:
• Fasting Mimicking Diet
Subject will consume 6 cycles of 5-day fasting mimicking diet: 3 days prior to, the day of, and 1 day following chemotherapy treatments.

Drug:
• Chemotherapy
6 cycles of standard chemotherapy for the gynecologic malignancy.

Locations

Country	Name	City	State
United States	The University of Tennessee Medical Center	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
L-Nutra Inc	University of Tennessee Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. Erratum In: Nature. 2020 Dec;588(7839):E33. — View Citation

de 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. — View Citation

Finnell 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. — View Citation

Goncalves 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. — View Citation

Lee 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. — View Citation

Moss 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. — View Citation

Raffaghello 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. — View Citation

Safdie 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 0-21
Primary	Rate of Adherence	The ability to adhere to a 5-day fasting mimicking diet.	Week 0-21
Secondary	Change in Body Weight	Change in body weight.	Week 0, Week12, Week 21
Secondary	Change in Body Composition	Changes in weight, skeletal muscle mass, body fat percentage by the Inbody(R) Body Composition Analyzer.	Week 0, Week12, Week 21
Secondary	Change in HbA1c	Change in blood HbA1c.	Week 0, Week 21
Secondary	Change in Insulin Like Growth Factor 1 (IGF-1) Concentration	Change in blood insulin like growth factor 1 level.	Week 0, Week 21
Secondary	Change in Fasting Insulin Concentration	Change in fasting insulin level.	Week 0, Week 21
Secondary	Change in Fasting Glucose Concentration	Change in fasting glucose level.	Week 0, Week 21
Secondary	Change in High-sensitivity C reactive protein Concentration	Change in blood C reactive protein level.	Week 0, Week 21
Secondary	Change in Leptin Concentration	Change in blood leptin level.	Week 0, Week 21
Secondary	Change in planned chemotherapy regimen	Deviation from the planned chemotherapy regimen.	Week 0-21
Secondary	Number of Hospitalization Days	Days of hospitalization	Week 0-21
Secondary	Rate of Chemotherapy Side Effects	Rate of Adverse effects associated with chemotherapy	Week 0-21