Ignite Creation Date:
2024-05-06 @ 5:59 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05503108
Status:
SUSPENDED
Last Update Posted:
2023-11-22
First Post:
2022-07-24
Brief Title:
Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive HR HER2- Breast Cancer
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
DIRECT-2 Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in HR HER2- Breast Cancer
Status:
SUSPENDED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
fultility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIRECT-2
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P22028 | OTHER | None | None |
| BOOG 2022-01 | OTHER | BOrstkanker Onderzoek Groep BOOG | None |