Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Leiden University Medical Center
With
The Netherlands Cancer Institute
Borstkanker Onderzoek Groep
Comprehensive Cancer Centre The Netherlands
Koningin Wilhelmina Fonds
World Cancer Research Fund International
L-Nutra Inc
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
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
Clareo Health | Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer
