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| ID | Type | Description | Link |
|---|---|---|---|
| BOOG2013-04 | Other Identifier | BOOG | |
| p13.135 | Other Identifier | CME LUMC |
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| Name | Class |
|---|---|
| Borstkanker Onderzoek Groep | NETWORK |
| Pink Ribbon Inc. | INDUSTRY |
| Amgen | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting mimicking diet | Experimental | Short term fasting using Fasting mimicking diet around neoadjuvant chemotherapy (AC>T) |
|
| regular diet | No Intervention | Standard neoadjuvant chemotherapy (AC>T) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting mimicking diet | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with grade III/IV toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version (NCI CTCAE) v4.03. | Phase II | 2 years |
| The percentage of pCR. | Phase III | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response measured by MRI (RECIST1.1) after 4 cycles chemotherapy. | 4 years | |
| Grade I/II side effects of chemotherapy according to NCI CTCAE v4.03. | 4 years | |
| Measure | Description | Time Frame |
|---|---|---|
| Protein profiles and cytokines used as biomarker to predict treatment outcome | 4 years | |
| Quantification of chemotherapy-induced DNA damage in leukocytes (with γ-H2AX modification and comet assay). | 3years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith R Kroep, MD, PhD | Leiden University Medical Center | Principal Investigator |
| Hanno Pijl, MD PhD | Leiden University Medical Center | Principal Investigator |
| Koos JM van der Hoeven, MD PhD Ir | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leids Universitair Medisch Centrum | Leiden | South Holland | 2333ZA | Netherlands | ||
| Medisch Centrum Alkmaar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33179154 | Derived | 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. | |
| 32576828 |
| Label | URL |
|---|---|
| Related Info | View source |
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| Metabolic (Glucose, insulin, insulin-like growth factor-I (IGF-I), insulin-like growth factor binding protein 3 (IGF-BP3), free thyroxin (FT4), triiodothyronine (T3) and thyroid-stimulating hormone (TSH)) and inflammatory response (CRP) to chemotherapy. |
| 4 years |
| DNA damage, apoptosis, immunology and nutrient sensing system activity in the tumor. | 5 years |
| Patient's quality of life (using EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires), burden of therapy noted by a visual analogue scale (VAS) (Distress Thermometer) and differences of Illness Perceptions (B-IPQ). | 4 years |
| Long term efficacy of treatment (DFS, OS). | 4years |
| Hormone receptor percentage, Ki67 and immunologic tumor profile and tumor/stroma ratio as predictive biomarker | 4 years |
| SNPs used as biomarker to predict treatment outcome. | 5 years |
| Quantification of nutrient sensing system gene expression (with western blot). | 3 years |
| 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 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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