Clinical trial · Interventional
A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies
NCT05356182CI-TRIAL-00107280recruitingN/AClinicalTrials.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)
The main idea of this study is that a low protein diet may alter the environment surrounding the tumor, enhancing the body's immune response leading to greater anticancer effects of treatment. This study intends to use a low-protein diet as a tool to enhance the immune response generated by immune check point inhibitor treatments.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Integrative Oncology | — | UNRESOLVED | — |
| Medical Nutrition Therapy | — | UNRESOLVED | — |
| Medical Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Diet Arm
- description
- control diet arm (\~20% protein content)
- interventionNames
- Other: Diet
- type
- ACTIVE_COMPARATOR
- label
- Low-Protein Diet Arm
- description
- intervention low-protein diet arm (10% protein content)
- interventionNames
- Other: Diet
Primary outcomes (2)
- measure
- To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.
- timeFrame
- 4 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically documented solid tumor malignancies which is amenable for immunotherapy treatment with immune checkpoint inhibitors (i.e. PD1, PD-L1, CTLA inhibitors) as single agents or in combination.
* Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan of the chest, abdomen, and pelvis
* Life expectancy of at least 6 months
* Adults ≥ 18 years of age
* Adequate hematologic, renal, and liver function as evidenced by the following:
* White blood cell (WBC) ≥ 2,500 cells/μL
* Absolute neutrophil count (ANC) ≥ 1,000 cells/μL
* Platelet Count ≥ 100,000 cells/μL
* Hemoglobin (HgB) ≥ 9.0 g/dL
* Creatinine ≤ 2.0 mg/dL
* Total bilirubin ≤ 2 x upper limit of normal (ULN)
* Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN
* Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN
Exclusion Criteria:
* • Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher
* Treatment with any of the following medications or interventions within 28 days of registration:
* Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.
* High dose calcitriol \[1,25(OH)2VitD\] (i.e., \> 7.0 μg/week)
* A requirement for systemic immunosuppressive therapy for any reason
* Any infection requiring parenteral antibiotic therapy or causing fever (temperature \> 100.5°F or 38.1°C) within 1 week prior to registration
* A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT imaging
* Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectivesReferences
Publications (0)
Data not yet available
No reference posted for this study.