Clinical trial · Interventional
Nutrition Impact on Immunotherapy of Cancer
Phase III Study on the Relation of Nutrition and Immunotherapy of Cancer Patients
NCT06500234CI-TRIAL-00078801recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study investigates nutritional status and outcomes of immuntherapy in cancer patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Immunotherapy | — | UNRESOLVED | — |
| Nutrition Disorders | — | UNRESOLVED | — |
| Survival, Prosthesis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Megestrol Acetate and olanzapine | Drug | — | UNRESOLVED |
| Starch powder 50 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- megestrol acetate-olanzapine
- description
- Megestrol acetate 160 mg, oral, everyday Olanzapine 2.5 mg, oral everyday
- interventionNames
- Drug: Megestrol Acetate and olanzapine
- type
- PLACEBO_COMPARATOR
- label
- control
- description
- Starch powder 50 mg, oral, everyday,
- interventionNames
- Drug: Starch powder 50 mg
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of cancer, malnutrition Age \>18 years Performance status ECOG of 0 or 2. Life expectancy ≥ 6 months. At least one lesion measurable as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1) Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment Postmenopausal or evidence of non-childbearing status for women of childbearing potential Patient is willing and able to comply with the protocol for the duration of the study. For all oral medications patients must be able to comfortably swallow capsules; Exclusion Criteria: * Patients unable to swallow orally administered medication and patients with Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs History of allogenic organ, bone marrow or double umbilical cord blood transplantation. Active or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness or patient considered a poor medical risk due to a serious, uncontrolled medical disorder, including but not limited to, ongoing or active infection, symptomatic congestive heart failure Currently taking medications with known risk of prolonging the QT interval or inducing Torsades de Pointes.
References
Publications (0)
Data not yet available
No reference posted for this study.