NCT04027478

Brief Summary

This is a prospective randomized crossover trial. Patients will be randomized to the FMD or regular diet during three rounds of chemotherapy. After the third round, patients will cross over to the opposite arm. The primary hypothesis is that there will be fewer cases of Grade 2-4 nausea when patients are in the FMD sequence. The primary objective is to assess differences in toxicities in patients undergoing chemotherapy with a combination of taxol/carboplatin when using a fasting mimicking diet when compared to normal diet before and after treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

June 26, 2019

Last Update Submit

July 18, 2019

Conditions

Chemotherapy EffectChemotherapeutic ToxicityFasting

Keywords

fastingchemotherapy

Outcome Measures

Primary Outcomes (1)

  • Nausea Grade

    Grade 2-4 nausea when patients are in the FMD sequence versus the non-fasting sequence

    16 weeks

Secondary Outcomes (3)

  • FMD Tolerability as measured by adverse events

    16 weeks

  • FMD Tolerability as measured by QOL Questionnaire

    16 weeks

  • Incidence of neutropenia

    16 weeks

Study Arms (2)

FMD (fasting-mimicking diet)

ACTIVE COMPARATOR

Over the course of three rounds of chemotherapy, patients in the FMD will consume a diet that consists of 10 cal/kg/day and includes 50% fat, 40% carbohydrates, and no more than 10% protein. The diet includes nuts, olives, vegetable broth, broccoli/cauliflower, white rice/puffed rice cake, onion, tea/coffee, almond milk. The diet prohibits meat products, dairy, alcohol, sugar, and artificial sweeteners. Patients will be instructed to drink 2 cups of water each morning, take their usual medications and limit exercise to walking.

Dietary Supplement: FMD

regular diet

NO INTERVENTION

Diet not influenced by a fast-mimicking diet.

Interventions

FMDDIETARY_SUPPLEMENT

fasting mimicking diet

FMD (fasting-mimicking diet)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • English speaking
  • Patients undergoing chemotherapy with Taxol/carboplatin planned for at least 6 cycles
  • Willing to comply with diet and tests
  • No significant medical problem that would make fasting dangerous (insulin dependent diabetes, history of hypoglycemia)

You may not qualify if:

  • Insulin dependent diabetes
  • Pregnancy
  • History of hypoglycemia, or any other medical condition that the treating physician considers not suitable for fasting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

Related Publications (10)

  • Di Biase S, Longo VD. Fasting-induced differential stress sensitization in cancer treatment. Mol Cell Oncol. 2015 Dec 10;3(3):e1117701. doi: 10.1080/23723556.2015.1117701. eCollection 2016 May.

    PMID: 27314084BACKGROUND

  • Levine ME, Suarez JA, Brandhorst S, Balasubramanian P, Cheng CW, Madia F, Fontana L, Mirisola MG, Guevara-Aguirre J, Wan J, Passarino G, Kennedy BK, Wei M, Cohen P, Crimmins EM, Longo VD. Low protein intake is associated with a major reduction in IGF-1, cancer, and overall mortality in the 65 and younger but not older population. Cell Metab. 2014 Mar 4;19(3):407-17. doi: 10.1016/j.cmet.2014.02.006.

    PMID: 24606898BACKGROUND

  • 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: 22323820BACKGROUND

  • Mendelsohn AR, Larrick JW. Prolonged fasting/refeeding promotes hematopoietic stem cell regeneration and rejuvenation. Rejuvenation Res. 2014 Aug;17(4):385-9. doi: 10.1089/rej.2014.1595.

    PMID: 25072352BACKGROUND

  • Safdie F, Brandhorst S, Wei M, Wang W, Lee C, Hwang S, Conti PS, Chen TC, Longo VD. Fasting enhances the response of glioma to chemo- and radiotherapy. PLoS One. 2012;7(9):e44603. doi: 10.1371/journal.pone.0044603. Epub 2012 Sep 11.

    PMID: 22984531BACKGROUND

  • 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: 21088487BACKGROUND

  • Brandhorst S, Longo VD. Fasting and Caloric Restriction in Cancer Prevention and Treatment. Recent Results Cancer Res. 2016;207:241-66. doi: 10.1007/978-3-319-42118-6_12.

    PMID: 27557543BACKGROUND

  • Wei M, Brandhorst S, Shelehchi M, Mirzaei H, Cheng CW, Budniak J, Groshen S, Mack WJ, Guen E, Di Biase S, Cohen P, Morgan TE, Dorff T, Hong K, Michalsen A, Laviano A, Longo VD. Fasting-mimicking diet and markers/risk factors for aging, diabetes, cancer, and cardiovascular disease. Sci Transl Med. 2017 Feb 15;9(377):eaai8700. doi: 10.1126/scitranslmed.aai8700.

    PMID: 28202779BACKGROUND

  • de Groot S, Vreeswijk MP, Welters MJ, Gravesteijn G, Boei JJ, Jochems A, Houtsma D, Putter H, van der Hoeven JJ, Nortier JW, Pijl H, Kroep JR. The effects of short-term fasting on tolerance to (neo) adjuvant chemotherapy in HER2-negative breast cancer patients: a randomized pilot study. BMC Cancer. 2015 Oct 5;15:652. doi: 10.1186/s12885-015-1663-5.

    PMID: 26438237BACKGROUND

  • Vasey PA, Jayson GC, Gordon A, Gabra H, Coleman R, Atkinson R, Parkin D, Paul J, Hay A, Kaye SB; Scottish Gynaecological Cancer Trials Group. Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. J Natl Cancer Inst. 2004 Nov 17;96(22):1682-91. doi: 10.1093/jnci/djh323.

    PMID: 15547181BACKGROUND

Related Links

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Stacy D'Andre, MD

    Sutter Health

    PRINCIPAL INVESTIGATOR

  • Carol Parise, PhD

    Sutter Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2019

First Posted

July 22, 2019

Study Start

September 1, 2019

Primary Completion

August 1, 2020

Study Completion

February 1, 2021

Last Updated

July 22, 2019

Record last verified: 2019-07

Locations

US(1)