Clinical Trial 23570

• Overview

  Study Title:

  Feasibility of Dietary Interventions for Optimizing CAR-T Cell Function in Cancer Patients and Adults without Cancer

  Objective:

  Aim 1: To evaluate study feasibility and adherence, acceptability, safety, and preliminary efficacy of a ketogenic diet or fasting-mimicking diet for LBLC or MM patients scheduled to receive CART-cell therapy. Aim 2: To refine and revise the dietary interventions for patients scheduled to receive CART-cell therapy based on participant feedback. Aim 3: To explore the preliminary efficacy of a ketogenic versus fasting-mimicking diet on quality of life, circulating cytokines, and immune cell populations in adults without cancer.

• Inclusion Criteria

  Key Inclusion Criteria:
  • Be age 18 or older
  • Have a diagnosis of LBCL or MM
  • Be planning to receive CAR T-cell therapy at Moffitt Cancer Center
  • Not previously have been treated with allogeneic HCT or CART
  • Have no documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., schizophrenia)
  • Be able to speak and read English
  • Be able to consume food orally
  • Have a body mass index > 18.5
  • Have no contra-indications to consuming either dietary intervention as assessed by their oncologist
  • Be able to provide informed consent

• Exclusion Criteria

  Key Exclusion Criteria:
  • Not meeting all of the inclusion criteria

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