RECRUITING

Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors

Conditions

Cancer PD-1/PD-L1 Inhibitors inflammatory cytokines gut microbiota

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

Cancer Nutrition Study: CaNS - A Pilot Study of Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors

Quick Facts

Study Start:2024-07-17

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06475807

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Be willing and able to provide written informed consent. 2. 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). 3. Patients must have any type of electronic device such as a smartphone, tablet, or computer etc that can access the internet. 4. Self-reported willingness to adhere with dietary intervention. 5. Self-reported willingness to comply to scheduled follow ups, fill out questionnaires/food logs, provide stool samples and undergo venipuncture 6. 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. 7. 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. 8. Melanoma patients with a single metastatic or recurrent lesion who have undergone tumor resection and are currently receiving adjuvant treatment with nivolumab or pembrolizumab. 9. 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.	1. Patients receiving ICIs enrolled in a clinical trial in the experimental arm. 2. Use of any of the following drugs within the last 4 weeks: 1. Systemic antibiotics, antifungals, antivirals, or antiparasitics (intravenous, intramuscular, or oral); 2. Oral, intravenous, intramuscular, nasal, or inhaled corticosteroids ((\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study intervention administration. Inhaled or topical steroids and adrenal replacement doses \>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease) 3. Cytokines. 4. Methotrexate or immunosuppressive cytotoxic agents. 5. Regularly taking probiotics, fiber supplements, or any other medication or pre-biotic dietary supplement that could affect the study outcome as determined by the principal investigator and unable/unwilling to discontinue for the study. These agents must be discontinued at least 14 days prior to the start of the diet. 3. Current use of chronic alcohol within the last 4 weeks, defined as more than five 1.5-ounce servings of 80-proof distilled spirits, five 12-ounce servings of beer, or five 5-ounce servings of wine per day. 4. Current consumption of fiber \>25g (determined based on patient reported intake or baseline DHQ3 assessment) or fermented food ≥≥3 portions a day (foods/drinks tested in the clinical trial, for example coffee beverage is considered to be a fermented drink but will not count towards the consume fermented food intake). 5. Any major bowel resection at any time. 6. Medical contraindications to intervention diet as determined by the treating physician. 7. Systemic antibiotics and proton pump inhibitors (PPis) are not allowable during the study (should be discontinued \>21 days prior). If PPIs or systemic antibiotics are initiated by the patient's treating physician, the patient should report this to the study team during the study period. 8. Unable or unwilling to adhere schedule interventions and study procedures. 9. History of active uncontrolled gastrointestinal disorders or diseases, including: 1. Inflammatory bowel disease (IBD), including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis. 2. Malabsorption (e.g active celiac disease) 3. Active Persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent), or Helicobacter pylori infection (untreated).

Inclusion Criteria

Exclusion Criteria

1. Be willing and able to provide written informed consent.
2. 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).
3. Patients must have any type of electronic device such as a smartphone, tablet, or computer etc that can access the internet.
4. Self-reported willingness to adhere with dietary intervention.
5. Self-reported willingness to comply to scheduled follow ups, fill out questionnaires/food logs, provide stool samples and undergo venipuncture
6. 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.
7. 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.
8. Melanoma patients with a single metastatic or recurrent lesion who have undergone tumor resection and are currently receiving adjuvant treatment with nivolumab or pembrolizumab.
9. 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.

1. Patients receiving ICIs enrolled in a clinical trial in the experimental arm.
2. Use of any of the following drugs within the last 4 weeks:
1. Systemic antibiotics, antifungals, antivirals, or antiparasitics (intravenous, intramuscular, or oral);
2. Oral, intravenous, intramuscular, nasal, or inhaled corticosteroids ((\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study intervention administration. Inhaled or topical steroids and adrenal replacement doses \>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease)
3. Cytokines.
4. Methotrexate or immunosuppressive cytotoxic agents.
5. Regularly taking probiotics, fiber supplements, or any other medication or pre-biotic dietary supplement that could affect the study outcome as determined by the principal investigator and unable/unwilling to discontinue for the study. These agents must be discontinued at least 14 days prior to the start of the diet.
3. Current use of chronic alcohol within the last 4 weeks, defined as more than five 1.5-ounce servings of 80-proof distilled spirits, five 12-ounce servings of beer, or five 5-ounce servings of wine per day.
4. Current consumption of fiber \>25g (determined based on patient reported intake or baseline DHQ3 assessment) or fermented food ≥≥3 portions a day (foods/drinks tested in the clinical trial, for example coffee beverage is considered to be a fermented drink but will not count towards the consume fermented food intake).
5. Any major bowel resection at any time.
6. Medical contraindications to intervention diet as determined by the treating physician.
7. Systemic antibiotics and proton pump inhibitors (PPis) are not allowable during the study (should be discontinued \>21 days prior). If PPIs or systemic antibiotics are initiated by the patient's treating physician, the patient should report this to the study team during the study period.
8. Unable or unwilling to adhere schedule interventions and study procedures.
9. History of active uncontrolled gastrointestinal disorders or diseases, including:
1. Inflammatory bowel disease (IBD), including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis.
2. Malabsorption (e.g active celiac disease)
3. Active Persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent), or Helicobacter pylori infection (untreated).

Contacts and Locations

Study Contact

Hassane M Zarour, MD

CONTACT

(412) 623-3272

zarourhm@upmc.edu

Khvaramze Shaverdashvili, MD

CONTACT

shaverdashvilik@upmc.edu

Principal Investigator

Hassane M Zarour, MD

PRINCIPAL_INVESTIGATOR

UPMC Hillman Cancer Center

Study Locations (Sites)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

Hassane M Zarour, MD, PRINCIPAL_INVESTIGATOR, UPMC Hillman Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-17

Study Completion Date2027-06

Study Record Updates

Study Start Date2024-07-17

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

PD-1/PD-L1 Inhibitors
inflammatory cytokines
gut microbiota

Additional Relevant MeSH Terms

Cancer