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Low-Protein Diet with Immunotherapy for Solid Tumors

This study is looking at whether a low-protein diet can improve how well immunotherapy works for people with solid tumor cancers. You might be able to join if you have a solid tumor that can be treated with immunotherapies like PD1, PD-L1, or CTLA inhibitors, and you have metastatic disease (cancer that has spread). Researchers want to see if it's practical for patients to follow a low-protein diet while receiving immunotherapy. The study plans to enroll 30 participants, but its current status is unclear. The main idea is that a low-protein diet might help your body's immune system fight cancer more effectively when combined with immunotherapy.

Study design
This is a randomized, open-label study involving 30 participants. You would be assigned by chance to either a control diet (about 20% protein) or an intervention low-protein diet (10% protein), both alongside immunotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The feasibility of the diet intervention will be measured at 4 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05356182

A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies

Recruiting
NAAges 18+InterventionalTreatment
State University of New York at Buffalo
~30 participants
Updated 2026-04-03 on ClinicalTrials.gov
What's tested:Diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.
Measured over 4 Months
+1 more outcome measured

Conditions

Medical Oncology
Integrative Oncology
Medical Nutrition Therapy

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Solid Neoplasm

NCT05356182

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University at Buffalo / Great Lakes Cancer Care

    Buffalo, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Ashlee Lang, MPH
[email protected]
716-860-0267
Email the study team

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Eligibility criteria

Inclusion

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

• 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 objectives

What this trial measures

  • To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.4 Months

    Change in blood urea nitrogen (BUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.

  • To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.4 Months

    Change in urine urea nitrogen (UUN) from baseline to post-intervention (following 3 cycles of treatment) will be measured to assess adherence of following the diet intervention.