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Trial Title:
Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer
NCT ID:
NCT05503108
Condition:
Fasting Mimicking Diet
HER2-negative Breast Cancer
Hormone Receptor-positive Breast Cancer
Pathological Complete Response
Objective Response Rate
Neoadjuvant Chemotherapy
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Suspended
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Fasting Mimicking diet program
Description:
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.
Arm group label:
Fasting Mimicking Diet group
Other name:
Xentigen™
Summary:
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:
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
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Noordwest Ziekenhuisgroep
Address:
City:
Alkmaar
Country:
Netherlands
Facility:
Name:
Rode Kruis ziekenhuis
Address:
City:
Beverwijk
Zip:
1942 LE
Country:
Netherlands
Facility:
Name:
Alexander Monro Ziekenhuis
Address:
City:
Bilthoven
Country:
Netherlands
Facility:
Name:
Reinier de Graaf ziekenhuis
Address:
City:
Delft
Country:
Netherlands
Facility:
Name:
Deventer Ziekenhuis
Address:
City:
Deventer
Country:
Netherlands
Facility:
Name:
Ziekenhuis Gelderse Vallei
Address:
City:
Ede
Country:
Netherlands
Facility:
Name:
Leiden University Medical Center
Address:
City:
Leiden
Country:
Netherlands
Start date:
March 17, 2023
Completion date:
January 1, 2024
Lead sponsor:
Agency:
Leiden University Medical Center
Agency class:
Other
Collaborator:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Borstkanker Onderzoek Groep
Agency class:
Other
Collaborator:
Agency:
Comprehensive Cancer Centre The Netherlands
Agency class:
Other
Collaborator:
Agency:
Koningin Wilhelmina Fonds
Agency class:
Other
Collaborator:
Agency:
World Cancer Research Fund International
Agency class:
Other
Collaborator:
Agency:
L-Nutra Inc
Agency class:
Industry
Source:
Leiden University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05503108
https://www.boogstudycenter.nl/studie/299/direct-2.html
