CancerNCT06475807
Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
A study testing High-fermented food and High fiber supplementation in people with Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- High-fermented food and High fiber supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2024to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Early stage (IB-IIIA) resected NSCLC patients on adjuvant pembrolizumab or atezolizumab.
- Early stage (IB-IIIA) NSCLC patients who are surgical candidates and are treated with neoadjuvant chemotherapy plus immunotherapy (nivolumab or pembrolizumab).
- (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).
- 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.
Who cannot join
- Patients receiving ICIs enrolled in a clinical trial in the experimental arm.
- Use of any of the following drugs within the last 4 weeks:
- Systemic antibiotics, antifungals, antivirals, or antiparasitics (intravenous, intramuscular, or oral);
- 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)
- Cytokines.
- Methotrexate or immunosuppressive cytotoxic agents.
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- 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.
- 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.
- 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).
- Any major bowel resection at any time.
- Medical contraindications to intervention diet as determined by the treating physician.
- 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.
- Unable or unwilling to adhere schedule interventions and study procedures.
- History of active uncontrolled gastrointestinal disorders or diseases, including:
- Inflammatory bowel disease (IBD), including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis.
- Malabsorption (e.g active celiac disease)
- Active Persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent), or Helicobacter pylori infection (untreated).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Hassane M Zarour, MD, (412) 623-3272, zarourhm@upmc.edu
About this study
Official title: 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)
Read the detailed description
Several studies have shown that diet can modulate the gut microbiome and affect the biology of the immune system. The role of the high-fermented food diet and high-fiber supplementation on gut microbiome in patients with cancer treated with immunotherapy will be evaluated. Fermented diet and high-fiber supplementation rational: a high-fermented food diet promotes gut microbiome composition and lowers systemic inflammatory markers. Additionally, high fiber diet may be associated with improved clinical outcomes in immune checkpoint inhibitor treated cancer patients. The effect of high-fermented food and high-fiber supplementation on gut microbiome and systemic inflammation in patients with cancer will be examined. The results of this study will be used to help to design future dietary intervention trials in cancer patients receiving immunotherapy. Baseline diet information, stool and blood samples will be collected. Patients initially receive high-fermented food diet for 4 weeks, followed by 2-week break/observation period and then cross over to high-fiber supplementation for another 4 weeks, followed by 2 weeks break/observation period. During break/observation period patients can eat any type of food, without dietary restrictions. During the dietary intervention period 24-hour dietary recall information will be collected, stool samples weekly and blood sample every 2-4 weeks.
- Conditions
- Cancer
- Being tested
- High-fermented food, High fiber supplementation
- Keywords
- PD-1/PD-L1 Inhibitors, inflammatory cytokines, gut microbiota
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fermented foodDietary supplement
Step 1: patients will consume high-fermented food
High fiber supplementationDietary supplement
Step 2: High fiber supplementation
| Study group | Role | What they receive |
|---|---|---|
| high-fermented food + high fiber supplementation | Experimental | Step 1: patients will consume high-fermented food
Step 2: High fiber supplementation Receives: Dietary Supplement: High-fermented food; Dietary Supplement: High fiber supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cell frequency of gut microbiota composition
Changes in gut microbiome diversity and function, evaluated with metagenomics, identify differentially abundant taxa and assess all genes in all organisms present in each fecal microbiota sample in pre- vs. post- each dietary using PERMANOVA. This will be measured as change of cell frequency and calculated as percentage change.
Measured: Up to 14 weeks
Secondary outcomes (2)
Adverse Events and Serious Adverse Events
Incidence of anti-PD-1/PD-L1 therapy treatment-related grade 3 or more toxicities per CTCAE v5.0
Measured: Up to 14 weeks
Changes in cell frequency of circulating adaptive immune cells
Changes in the circulating adaptive and innate cells in the systemic circulation, evaluated with multiparameter flow cytometry, peripheral blood mononuclear cells will be used to evaluate cell frequency, phenotype, and function. This will be measured as change of cell frequency and calculated as percentage change.
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start17 Jul 2024
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassane M. Zarour, MD, University of Pittsburgh
- Investigators
- Hassane M Zarour, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475807
- Sponsor's protocol ID
- HCC 23-105
- Status last verified
- Mar 2026
- First submitted
- 4 Jun 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Nutrition Study: CaNS - A Pilot Study of Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT06475807
- Acronym / sponsor ID
- HCC 23-105
- Conditions
- Cancer
- Keywords
- PD-1/PD-L1 Inhibitors, inflammatory cytokines, gut microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Several studies have shown that diet can modulate the gut microbiome and affect the biology of the immune system. The role of the high-fermented food diet and high-fiber supplementation on gut microbiome in patients with cancer treated with immunotherapy will be evaluated. Fermented diet and high-fiber supplementation rational: a high-fermented food diet promotes gut microbiome composition and lowers systemic inflammatory markers. Additionally, high fiber diet may be associated with improved clinical outcomes in immune checkpoint inhibitor treated cancer patients. The effect of high-fermented food and high-fiber supplementation on gut microbiome and systemic inflammation in patients with cancer will be examined. The results of this study will be used to help to design future dietary intervention trials in cancer patients receiving immunotherapy. Baseline diet information, stool and blood samples will be collected. Patients initially receive high-fermented food diet for 4 weeks, followed by 2-week break/observation period and then cross over to high-fiber supplementation for another 4 weeks, followed by 2 weeks break/observation period. During break/observation period patients can eat any type of food, without dietary restrictions. During the dietary intervention period 24-hour dietary recall information will be collected, stool samples weekly and blood sample every 2-4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high-fermented food + high fiber supplementation | Experimental | Dietary Supplement: High-fermented food, Dietary Supplement: High fiber supplementationStep 1: patients will consume high-fermented food Step 2: High fiber supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (17 listed)
- Patients receiving ICIs enrolled in a clinical trial in the experimental arm.
- Use of any of the following drugs within the last 4 weeks:
- 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.
- 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).
- Any major bowel resection at any time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-fermented foodStep 1: patients will consume high-fermented food | Dietary supplement | high-fermented food + high fiber supplementation |
| High fiber supplementationStep 2: High fiber supplementation | Dietary supplement | high-fermented food + high fiber supplementation |
Primary outcome
Change in cell frequency of gut microbiota composition
Time frame: Up to 14 weeks
Changes in gut microbiome diversity and function, evaluated with metagenomics, identify differentially abundant taxa and assess all genes in all organisms present in each fecal microbiota sample in pre- vs. post- each dietary using PERMANOVA. This will be measured as change of cell frequency and calculated as percentage change.
2 secondary outcomes
Adverse Events and Serious Adverse Events
Time frame: Up to 14 weeks
Changes in cell frequency of circulating adaptive immune cells
Time frame: Up to 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hassane M Zarour, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fermented food and High fiber supplementation in people with Cancer, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hassane M Zarour, MD ((412) 623-3272, zarourhm@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cell frequency of gut microbiota composition (time frame: Up to 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.