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Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer

NCT ID: NCT05503108

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-17

Study Completion Date

2024-01-01

Brief Summary

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In preclinical research, short-term fasting (STF) protects tumor-bearing mice against the toxic effects of chemotherapy, improves the CD8+ effector T-cell intratumor infiltration, while enhancing the chemotherapy efficacy. Short-term use of a "fasting-mimicking diet" (FMD) caused a major increase in the efficacy of cancer treatment in mice comparable to STF. In humans, the investigators recently performed a multicenter randomized phase II trial showing that patients with Human Epidermal growth factor Receptor 2 (HER2) negative breast cancer treated with neoadjuvant chemotherapy and FMD displayed a better radiological response and a better pathological response (90-100% vs \<90% tumor cell reduction) than patients treated with chemotherapy without FMD (de Groot, Nat Commun 2020; NCT02126449). Therefore these findings will be validated in a phase 3 trial with the underlying hypothesis that FMD during neoadjuvant chemotherapy for breast cancer improves clinical outcomes, potentially due to improved local immunity.

Detailed Description

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STF during neadjuvant chemotherapy aiming to improve the chemotherapy efficacy and decline the side effects in patients with stage II-III HR+, HER2- breast cancer

Conditions

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Fasting Mimicking Diet HER2-negative Breast Cancer Hormone Receptor-positive Breast Cancer Pathological Complete Response Objective Response Rate Neoadjuvant Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fasting Mimicking Diet group

Fasting Mimicking Diet 3 days before and the day of neoadjuvant chemotherapy (ddAC, T)

Group Type EXPERIMENTAL

Fasting Mimicking diet program

Intervention Type OTHER

Fasting mimicking diet by L-Nutra, a 4-day low caloric, low protein, vegetarian diet 3 days prior to and the day of neoadjuvant chemotherapy administration. The FMD will take place every 4 weeks, thus in total 5 times (2x during ddAC, 3x during Paclitaxel) during the neoadjuvant chemotherapy.

Normal Diet group

Standard neoadjuvant chemotherapy (ddAC, T)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fasting Mimicking diet program

Fasting mimicking diet by L-Nutra, a 4-day low caloric, low protein, vegetarian diet 3 days prior to and the day of neoadjuvant chemotherapy administration. The FMD will take place every 4 weeks, thus in total 5 times (2x during ddAC, 3x during Paclitaxel) during the neoadjuvant chemotherapy.

Intervention Type OTHER

Other Intervention Names

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Xentigen™

Eligibility Criteria

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Inclusion Criteria

* Clinical stage II-III (cT1cN+ or ≥T2 any cN, cM0), HR+, HER2- breast cancer
* Detectable and measurable disease (breast and/or lymph nodes)
* World Health Organization (WHO) performance status 0-2
* Adequate organ function assessed by standard pre-treatment assessment:
* Adequate bone marrow function: white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
* Adequate liver function: bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
* Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
* Available for treatment and follow-up
* Written informed-consent
* Willing to fill in Quality Of Life and Cognition questionnaires
* Ability to read and understand Dutch language, accessibility to a computer with internet connection and independent use of computer

Exclusion Criteria

* Patient history of invasive or ipsilateral non-invasive breast cancer
* Active malignancy in the last 5 years, with the exclusion of basal cell carcinoma or pre-invasive cervical neoplasia/dysplasia.
* Body mass index (BMI) \< 18.5 kg/m2
* Pregnancy or lactating
* Food allergy for ingredients of FMD (nuts, soy, honey)
* A metabolic condition affecting gluconeogenesis or adaptation to periodic fasting. (Diabetes Mellitus for example)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Cancer Institute

OTHER

Sponsor Role collaborator

Borstkanker Onderzoek Groep

NETWORK

Sponsor Role collaborator

Comprehensive Cancer Centre The Netherlands

OTHER

Sponsor Role collaborator

Koningin Wilhelmina Fonds

OTHER

Sponsor Role collaborator

World Cancer Research Fund International

OTHER

Sponsor Role collaborator

L-Nutra Inc

INDUSTRY

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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J.R. Kroep

Drs J.R. Kroep

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith R Kroep, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

Site Status

Rode Kruis ziekenhuis

Beverwijk, , Netherlands

Site Status

Alexander Monro Ziekenhuis

Bilthoven, , Netherlands

Site Status

Reinier de Graaf ziekenhuis

Delft, , Netherlands

Site Status

Deventer Ziekenhuis

Deventer, , Netherlands

Site Status

Ziekenhuis Gelderse Vallei

Ede, , Netherlands

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 32576828 (View on PubMed)

Lugtenberg RT, de Groot S, Kaptein AA, Fischer MJ, Kranenbarg EM, Carpentier MD, Cohen D, de Graaf H, Heijns JB, Portielje JEA, van de Wouw AJ, Imholz ALT, Kessels LW, Vrijaldenhoven S, Baars A, Fiocco M, van der Hoeven JJM, Gelderblom H, Longo VD, Pijl H, Kroep JR; Dutch Breast Cancer Research Group (BOOG). Quality of life and illness perceptions in patients with breast cancer using a fasting mimicking diet as an adjunct to neoadjuvant chemotherapy in the phase 2 DIRECT (BOOG 2013-14) trial. Breast Cancer Res Treat. 2021 Feb;185(3):741-758. doi: 10.1007/s10549-020-05991-x. Epub 2020 Nov 11.

Reference Type BACKGROUND
PMID: 33179154 (View on PubMed)

de Groot S, Pijl H, van der Hoeven JJM, Kroep JR. Effects of short-term fasting on cancer treatment. J Exp Clin Cancer Res. 2019 May 22;38(1):209. doi: 10.1186/s13046-019-1189-9.

Reference Type BACKGROUND
PMID: 31113478 (View on PubMed)

Di Biase S, Lee C, Brandhorst S, Manes B, Buono R, Cheng CW, Cacciottolo M, Martin-Montalvo A, de Cabo R, Wei M, Morgan TE, Longo VD. Fasting-Mimicking Diet Reduces HO-1 to Promote T Cell-Mediated Tumor Cytotoxicity. Cancer Cell. 2016 Jul 11;30(1):136-146. doi: 10.1016/j.ccell.2016.06.005.

Reference Type BACKGROUND
PMID: 27411588 (View on PubMed)

Related Links

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https://www.boogstudycenter.nl/studie/299/direct-2.html

Related Info

Other Identifiers

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P22.028

Identifier Type: OTHER

Identifier Source: secondary_id

BOOG 2022-01

Identifier Type: OTHER

Identifier Source: secondary_id

NL80749.058.22 DIRECT 2

Identifier Type: -

Identifier Source: org_study_id