Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

NCT06376604 | Recruiting

• 1 other identifier: LNT55
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer, Ovarian; Chemotherapy Effect; Calorie Deficiency; Fasting, Intermittent

Keywords

Fasting mimicking diet; Gynecologic malignancy; Chemotherapy

Outcome Measures

Primary Outcomes (2)

• 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

• Rate of Adherence

  The ability to adhere to a 5-day fasting mimicking diet.

  Week 0-21

Secondary Outcomes (11)

• Change in Body Weight

  Week 0, Week12, Week 21

• Change in Body Composition

  Week 0, Week12, Week 21

• Change in HbA1c

  Week 0, Week 21

• Change in Insulin Like Growth Factor 1 (IGF-1) Concentration

  Week 0, Week 21

• Change in Fasting Insulin Concentration

  Week 0, Week 21

Study Arms (2)

FMD

EXPERIMENTAL

In addition to the standard care, subject will consume a 5-day fasting mimicking diet.

Other: Fasting Mimicking Diet; Drug: Chemotherapy

Control

ACTIVE COMPARATOR

Subjects will receive the standard care and no dietary changes.

Drug: Chemotherapy

Interventions

Fasting Mimicking Diet OTHER

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

FMD

Chemotherapy DRUG

6 cycles of standard chemotherapy for the gynecologic malignancy.

Control; FMD

Eligibility Criteria

• Age: 35 Years - 70 Years
• Gender Eligibility Details: The study focuses on the chemotherapy of gynecologic malignancies.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• L-Nutra Inc: lead
• University of Tennessee Medical Center: collaborator

Study Sites (1)

The University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

Related 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.

  PMID: 32669709 BACKGROUND

• 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.

  PMID: 32576828 BACKGROUND

• 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.

  PMID: 29458369 BACKGROUND

• 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.

  PMID: 32694797 BACKGROUND

• 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.

  PMID: 22323820 BACKGROUND

• 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.

  PMID: 21088487 BACKGROUND

• 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.

  PMID: 20157582 BACKGROUND

• 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.

  PMID: 29174565 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Intermittent Fasting

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jonathan D Boone

  The University of Tennessee Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Wei, PhD

CONTACT

323.791.2426; mwei@l-nutra.com

Jonathan D Boone, MD

CONTACT

8653055622; jboone@utmck.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcomes Assessor
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 19, 2024
• Study Start: September 8, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 30, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)