Clinical trial NCT05356182: A Pilot and Feasibility Study of a Dietary Intervention with Low-protein Meals in Cancer Patients Receiving Immunotherapies
Official title: A Pilot and Feasibility Study of a Dietary Intervention with Low-protein Meals in Cancer Patients Receiving Immunotherapies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medical Oncology
Integrative Oncology
Medical Nutrition Therapy
Keywords: Oncology
Nutrition
Immunotherapy
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a single center, randomized, open label study to assess the feasibility of a low-protein diet intervention in cancer patients who are receiving immunotherapies. Subjects will be randomized in a 1:1 ratio to either immunotherapy plus control diet arm (\~20% protein content) or immunotherapy plus intervention low-protein diet arm (10% protein content).

Eligibility criteria: 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

Primary outcomes:
measure: To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.
timeFrame: 4 Months
measure: To assess the feasibility of low-protein diet intervention in cancer patients receiving immunotherapies.
timeFrame: 4 Months
Secondary outcomes:
measure: To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies
timeFrame: 4 Months
measure: To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies
timeFrame: 4 Months
measure: To assess whether low-protein diet intervention augments the immune response to immunotherapies in cancer patients receiving immunotherapies
timeFrame: 4 Months
measure: To assess the enrollment rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention
timeFrame: 4 Months
measure: To assess the Drop-out rate (safety and tolerability) of the combination of immunotherapies and low-protein diet intervention
timeFrame: 4 Months
measure: To assess the safety and tolerability of the combination of immunotherapies and low-protein diet intervention
timeFrame: 4 Months
measure: To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria
timeFrame: 4 Months
measure: To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria
timeFrame: 4 Months
measure: To obtain preliminary evidence of clinical efficacy of immunotherapies and low-protein diet compared to immunotherapies and control-diet using the RECIST v1.1 criteria
timeFrame: 4 Months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo / Great Lakes Cancer Care
state: New York
Study officials:
References: