Clinical trial · Interventional
Gluten Free Diet in Diminishing Side Effects Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
Gluten Free Diet for AML Patients Undergoing Induction Chemotherapy
NCT03108911CI-TRIAL-00030390terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): limited resources
Summary
Brief summary (as posted)
This randomized phase II trial studies how well a gluten free diet works in diminishing side effects in patients with acute myeloid leukemia undergoing induction chemotherapy. A gluten free diet may result in less intestinal side effects and blood infections during the induction chemotherapy compared to a standard diet.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Dietary Intervention | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (GFD)
- description
- Patients receive GFD prepared by the hospital per dietary/nutrition pharmacy standards from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Dietary Intervention
- Other: Laboratory Biomarker Analysis
- type
- EXPERIMENTAL
- label
- Group II (standard diet)
- description
- Patients receive a standard diet for from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). Patients also complete a daily food intake diary. A stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.
- interventionNames
- Other: Best Practice
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing AML induction chemotherapy with an anthracycline + cytarabine-based chemotherapy regimen * No history of celiac disease or non-celiac gluten sensitivity * No grade 3 or 4 gastrointestinal (GI) toxicity at time of initial screening * No documented bacteremia at time of initial screening * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at time of initial screening Exclusion Criteria: * Pregnant women
References
Publications (0)
Data not yet available
No reference posted for this study.