Cancer Nutrition Study: CaNS - A Pilot Study of Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
This pilot trial will study the potential impact of two distinct dietary interventions with sequential use of high-fermented foods and high-fiber supplements on the gut microbiome and antitumor immunity in patients with melanoma and non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors. The trial aims to understand how dietary changes affect the composition and function of the gut microbiome, together with immunological and metabolomic markers in serum in patients with melanoma and NSCLC who are undergoing standard-of-care treatment with a PD-1/PD-L1 Inhibitors (neoadjuvant, adjuvant or consolidation)
• Be willing and able to provide written informed consent.
• Adult ≥ 18 years of age, willing and able to provide blood and stool specimen and comply with dietary modification, as well as willing to fill out study required questionnaires (paper or electronic and web-based).
• Patients must have any type of electronic device such as a smartphone, tablet, or computer etc that can access the internet.
• Body mass index (BMI) 18.5-40 kg/m2.
• Self-reported willingness to adhere with dietary intervention.
• Self-reported willingness to comply to scheduled follow ups, fill out questionnaires/food logs, provide stool samples and undergo venipuncture
• Patients who are treated or about to start treatment with standard of care anti-PD-1/PD-L1 therapy will be consented for the dietary intervention study I. Early stage (IIB-IIIC) resected melanoma patient on adjuvant pembrolizumab or nivolumab.
• II. Early stage (IB-IIIA) resected NSCLC patients on adjuvant pembrolizumab or atezolizumab.
• III. Early stage (IB-IIIA) NSCLC patients who are surgical candidates and are treated with neoadjuvant chemotherapy plus immunotherapy (nivolumab or pembrolizumab).
• a. (patients can be enrolled in the study at any point during their treatment period) IV. Stage IIIB or IIIC NSCLC after concurrent chemotherapy and radiotherapy followed by consolidation immunotherapy (durvalumab).
• V. LS-SCLC after concurrent chemotherapy and radiotherapy followed by consolidation immunotherapy (durvalumab)
• Melanoma patients with stage IIB-IIIC, currently enrolled in a clinical trial and randomized to the standard of care arm (e.g., adjuvant nivolumab or adjuvant pembrolizumab), as permitted by the protocols of the enrolled clinical trial.
• Melanoma patients with a single metastatic or recurrent lesion who have undergone tumor resection and are currently receiving adjuvant treatment with nivolumab or pembrolizumab.
• Stage IIB-IIIA NSCLC patients currently enrolled in a clinical trial and randomized to the standard of care anti-PD1/anti-PD-L1 arm after tumor resection or stage IIIB/C NSCLC or LS-SCLC patients after concurrent chemo/RT enrolled in a clinical trial and randomized to the standard of care consolidation immunotherapy arm as permitted by the protocols of the enrolled clinical trial.