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Brief Title: DIetary REstriction as an Adjunct to Neoadjuvant ChemoTherapy for HER2 Negative Breast Cancer
Official Title: DIetary REstriction as an Adjunct to Neoadjuvant ChemoTherapy for HER2 Negative Breast Cancer
Study ID: NCT02126449
Brief Summary: Preclinical studies provide strong support for the concept that fasting evokes resistance to multiple forms of stress. Fasting reduces plasma levels of growth factors and modulates intracellular nutrient sensing systems, thereby diverting energy from growth to maintenance. Accordingly, the currently available preclinical evidence suggests that short-term fasting protects normal cells against the perils of chemotherapy. In contrast, cancer cells are not protected, as a result of their self-sufficiency in growth signals. This phenomenon is termed Differential Stress Resistance (DSR). DSR reduces the severity of toxic side-effects of chemotherapy and interestingly, it simultaneously renders cancer cells more vulnerable to chemotherapeutics. Importantly, extensive preclinical evidence and preliminary clinical data indicate that a specifically designed very low calorie, low amino acid substitution diet ("Fasting Mimicking Diet, FMD") has effects on cancer therapy that are very similar to those of fasting. This study aims to evaluate the impact of the FMD on tolerance to and efficacy of neoadjuvant chemotherapy in women with stage II or III breast cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Leids Universitair Medisch Centrum, Leiden, Zuid-holland, Netherlands
Medisch Centrum Alkmaar, Alkmaar, , Netherlands
OLVG, Amsterdam, , Netherlands
Alexander Monro hospital, Bilthoven, , Netherlands
Amphia Hospital, Breda, , Netherlands
Deventer Hospital, Deventer, , Netherlands
Ziekenhuis Gelderse Valei, Ede, , Netherlands
, Catharina ziekenhuis Hospital, Eindhoven, , Netherlands
Kennemer gasthuis, Haarlem, , Netherlands
Medisch Centrum Leeuwarden, Leeuwarden, , Netherlands
Bronovo Hospital, The Hague, , Netherlands
Haga Hospital, The Hague, , Netherlands
VieCurie Hospital, Venlo, , Netherlands
Lange Land Hospital, Zoetermeer, , Netherlands
Isala, Zwolle, , Netherlands
Name: Judith R Kroep, MD, PhD
Affiliation: Leiden University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Hanno Pijl, MD PhD
Affiliation: Leiden University Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Koos JM van der Hoeven, MD PhD Ir
Affiliation: Leiden University Medical Center
Role: PRINCIPAL_INVESTIGATOR