Low-protein diet to enhance immunotherapy effects in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the feasibility of a low-protein diet in cancer patients undergoing immunotherapy. Participants will be randomly assigned to receive either a standard diet with approximately 20% protein or a low-protein diet containing 10% protein while receiving immune checkpoint inhibitors. The goal is to determine if the low-protein diet can improve the immune response and enhance the anticancer effects of the treatment. This is a single-center, open-label study focused on patients with solid tumor malignancies.

Why it matters

Who can join: the full rules

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 objectives

Where it's running

• University at Buffalo / Great Lakes Cancer Care
  Buffalo, New York, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intermittent caloric restriction and plant-based diet for cancer patients undergoing chemotherapy

  This study tests if a mix of eating less on some days and following a plant-based diet can help cancer patients on chemotherapy feel better and get more benefit from their treatment.

  Recruiting at 2 sites State University of New York at Buffalo · Buffalo, New York and 1 other locations · NCT05359848

• Plant-protein dominant tube feeding for adults at home

  This trial tests whether reformulated plant-protein dominant tube feeds work as well as animal-protein feeds for adults who receive tube feeding at home.

  Recruiting Nutricia UK Ltd · Trowbridge, Wiltshire · NCT07422935

• Improving how feeding tubes are placed in children using proven best practices.

  This project will try updated evidence-based methods and nurse education to improve feeding tube placement for hospitalized children.

  Recruiting at 22 sites Children's Hospital of Fudan University · Shanghai, Minhang and 21 other locations · NCT07038538

• Comparing continuous and bolus protein delivery in critically ill children

  This study is testing whether giving protein to critically ill children in larger amounts at once helps them get better nutrition and maintain their body size better than giving it continuously over time.

  Recruiting University of British Columbia · Vancouver, British Columbia · NCT06721923

• Impact of Oral Nutrition Before Gtube Feeding in ALS Patients

  This study is testing if eating a special nutrition formula before getting a feeding tube helps people with ALS handle the tube feedings better and possibly slow down their disease.

  Recruiting Nova Southeastern University · Fort Lauderdale, Florida · NCT06609213

• Improving recovery in elderly patients with frailty undergoing surgery for digestive cancer

  This study tests whether a special program that includes nutrition and exercise can help older patients with frailty recover better after surgery for digestive cancer.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT04715581

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.