Trials / Suspended
SuspendedNCT05503108
Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer
DIRECT-2: Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in HR+, HER2- Breast Cancer
- Status
- Suspended
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Leiden University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Fasting Mimicking Diet
- HER2-negative Breast Cancer
- Hormone Receptor-positive Breast Cancer
- Pathological Complete Response
- Objective Response Rate
- Neoadjuvant Chemotherapy
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Fasting Mimicking diet program | 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. |
Timeline
- Start date
- 2023-03-17
- Primary completion
- 2024-01-01
- Completion
- 2024-01-01
- First posted
- 2022-08-16
- Last updated
- 2023-11-22
Locations
7 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05503108. Inclusion in this directory is not an endorsement.