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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorState University of New York at Buffalo

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

• Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher

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

Trial design

Treatments tested in this trial

  • Diet

Treatment groups

30 Participants
are divided into 2 treatment groups