Solid Tumor CancerCaNSNCT07804225
Cancer Nutrition Study - A Study of Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
A study testing High-Fermented Food Diet and HI-MAIZE 260 Resistant Starch in people with Solid Tumor Cancer and Immune-Related Adverse Events, run by Thomas Jefferson University.
Trial summary
The goal of this clinical trial is to learn whether changing the diet can help improve gut health and support recovery from immune-related side effects caused by immune checkpoint inhibitor (ICI) cancer treatment in adults with solid tumors who develop moderate to severe immune-related side effects that require… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer, Immune-Related Adverse Events
- What is being tested?
- High-Fermented Food Diet and HI-MAIZE 260 Resistant Starch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jun 2030
- Phase
- Interventional
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
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- 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.
- 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 actively receiving ICIs and remain on this during the dietary intervention period (anti-PD-1/PD-L1, anti-CTLA4, anti-LAG3 or other immunotherapy that is currently FDA approved or listed in NCCN or ASCO guidelines for treatment of any solid malignancy, for example if patient is enrolled in clinical trial, studying pebrolizumab in any solid malignancy for new indication, these patients can be enrolled in this trial, given safety and efficacy of this ICI is well studied and approved in multiple settings) will be consented for the dietary intervention study.
- Any solid tumor (e.g., lung, melanoma, breast, head and neck, etc.) patients with grade ≥2 cutaneous (rash, dermatitis etc), constitutional (fatigue),rheumatological (arthralgia, arthritis) or GI (colitis, diarrhea, enteritis) irAEs while treated with ICIs i. Treated with topical steroids ii. Treated with systemic steroids or other immunemodulators iii. Are willing and able to continue ICIs concomitant with dietary intervention
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Use of systemic antibiotics, antifungals, antivirals, or antiparasitics (intravenous, intramuscular, or oral) within the last 14 days
- Use of oral, intravenous, intramuscular, nasal, or inhaled 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, unless the regimen is deemed appropriate by the study investigator (e.g., use of low-dose hydroxychloroquine may be permitted at the investigator's discretion)
- Regularly taking probiotics, fiber supplements, or any other medication or prebiotic 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
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- 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 >30g (determined based on patient-reported intake or baseline questionnaire assessment [DHQ3 or ASA24]) or fermented food >3 portions a day (foods/drinks tested in the clinical trial: kefir, buttermilk, kimchi, sauerkraut, brine drinks, and kombucha)
- Any major bowel resection at any time. If patient had partial bowel resection ≥1 year ago, may be permitted at the investigator's discretion
- History of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted)
- 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 >14 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
- o Note: Administration of antibiotics for procedural purposes such as during wide local excision of a tumor, lymph node biopsy, or similar interventions will not be considered a protocol deviation but must be reported and documented
- Unable or unwilling to adhere to scheduled interventions and study procedures
- Patient with life-threatening irAEs including but not limited to myocarditis, encephalitis, or vasculitis
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cancer Nutrition Study: CaNS - A Pilot Study of Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
The goal of this clinical trial is to learn whether changing the diet can help improve gut health and support recovery from immune-related side effects caused by immune checkpoint inhibitor (ICI) cancer treatment in adults with solid tumors who develop moderate to severe immune-related side effects that require steroid treatment.
The main questions it aims to answer are:
Read more
Does a high-fermented food diet or a high-fiber resistant starch supplement change the gut microbiome (the bacteria and other microorganisms that live in the digestive tract) during treatment? Does either dietary approach improve gut microbiome diversity and function by the end of the 7-week intervention period?
Researchers will compare participants assigned to a high-fermented food diet with participants assigned to high-fiber resistant starch supplementation to see if one approach leads to greater improvements in the gut microbiome and related biological measures.
Participants will:
Be randomly assigned to 1 of 2 dietary intervention groups:
High-fermented food diet High-fiber resistant starch supplement Follow their assigned diet for 7 weeks, starting when their ICI treatment is restarted.
Provide stool samples before the intervention begins and regularly throughout the study.
Have blood samples collected at the start of the study and approximately every 3 to 4 weeks during participation.
Provide skin and mouth swab samples at the beginning of the study and again at Week 7.
Complete food diaries and symptom assessments during the study. Participate in a 2-week follow-up period after completing the dietary intervention.
Researchers will also evaluate the safety of the dietary interventions, whether immune-related side effects return, how the immune system responds, and how closely participants follow their assigned diet.
Read the detailed description
OBJECTIVES:
Primary:
- To longitudinally assess changes in gut microbiota composition, diversity, and metabolomic function in patients with solid tumors who develop grade ≥2 irAEs during ICI therapy and undergo dietary modification with either high-fermented foods (Arm 1) or high-fiber supplementation (Arm 2).
Secondary:
- To determine the safety and tolerability of dietary interventions in patients with ICI-related irAEs
- To assess the incidence and severity of recurrent or new irAEs during and after dietary intervention
- To characterize changes in circulating innate and adaptive immune cell populations (frequency, phenotype, and function) associated with dietary modification
- To measure changes in circulating inflammatory cytokines and metabolites associated with dietary intervention
Exploratory:
- To assess patient-reported gastrointestinal symptoms and quality of life during dietary intervention
- To determine adherence rates to assigned dietary interventions using dietary logs and biomarker validation
- To explore associations between baseline physical activity levels and gut microbiome composition
- To longitudinally assess skin and oral microbiota composition, diversity, and function in relation to dietary modification
- To perform integrative multi-omic analyses exploring relationships between diet, microbiome, immune phenotypes, and clinical outcomes
- Conditions
- Solid Tumor Cancer, Immune-Related Adverse Events
- Being tested
- High-Fermented Food Diet, HI-MAIZE 260 Resistant Starch
- Keywords
- Immune Checkpoint Inhibitors, Gut Microbiome, Food Log, Food Diet, High-Fiber Supplementation, High-Fermented Food Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Fermented Food DietBehavioural
Participants will consume a high-fermented food diet consisting of at least 6 servings of fermented foods per day for 7 weeks. Participants will receive dietary counseling and regular follow-up with a nutritionist to support adherence to the assigned dietary intervention.
HI-MAIZE 260 Resistant StarchDietary supplement
Participants will receive HI-MAIZE 260, high-amylose cornstarch resistant starch dietary fiber supplement, daily for 7 weeks. Participants will receive dietary counseling and regular follow-up with a nutritionist to support adherence to the assigned dietary intervention.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: High-Fermented Food Diet - HFFD | Experimental | Participants will consume a high-fermented food diet consisting of at least 6 servings of fermented foods per day for 7 weeks. Receives: Behavioral: High-Fermented Food Diet |
| Arm 2: High-Fiber Supplementation - HFS | Experimental | Participants will receive HI-MAIZE 260 resistant starch supplementation for 7 weeks. Receives: Dietary Supplement: HI-MAIZE 260 Resistant Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gut Microbiota composition
To longitudinally assess changes in gut microbiota composition, in patients with solid tumors who develop grade ≥2 irAEs during ICI therapy and undergo dietary modification with either high-fermented foods (Arm 1) or high-fiber supplementation (Arm 2).
Measured: Baseline through Week 7
Secondary outcomes (5)
Incidence of Adverse Events related to dietary intervention
The incidence and severity of adverse events related to dietary intervention will be graded per CTCAE v5.0.
Measured: Baseline throguh Week 9 (approximately 11 weeks)
Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score
Tolerability will be assessed using the Gastrointestinal Symptom Rating Scale at baseline and every 2 weeks throughout the study period. Gastrointestinal Symptom Rating Scale (GSRS) Score is a 15-item patient-reported measure of gastrointestinal symptom severity. Items are scored from 1 (no discomfort) to 7 (very severe discomfort). Total scores range from 15 to 105, with higher scores indicating more severe gastrointestinal symptoms and a worse outcome.
Measured: Baseline through Week 9 (approximately 11 weeks)
Incidence of new immune-related adverse events following ICI re-initiation
New grade ≥2 irAEs will be monitored by organ system following ICI re-initiation, including severity grading per CTCAE v5.0
Measured: 12 months
Changes in Circulating Immune Cells
Changes from baseline to end of intervention will be assessed in the circulating innate immune cells. Measurements will be obtained at baseline (Week -2 to -1), Week 4, Week 7, and post-intervention (Week 8 or 9).
Measured: Baseline, Weeks 4, 7, and Week 8-9
Change From Baseline in Concentration of Circulating Inflammatory Markers
Changes from baseline to the end of the intervention will be assessed in circulating inflammatory markers. Measurements will be obtained at baseline (Week -2 to -1), Week 4, Week 7, and post-intervention (Week 8 or 9). Specific markers to be measured and reported:
- Interleukin-6 (IL-6)
- Tumor necrosis factor-alpha (TNF-alpha)
- Interferon-gamma (IFN-gamma)
- Interleukin-17A (IL-17A)
- Interleukin-1 beta (IL-1 beta)
- Interleukin-10 (IL-10)
- CXCL10
- High-sensitivity C-reactive protein (hs-CRP)
Measured: Baseline, Weeks 4, 7, and Week 8-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2029 (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 Solid Tumor CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khvaramze Shaverdashvili, M.D. PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804225
- Sponsor's protocol ID
- iRISID-2026-1168
- Other IDs
- JT 48688
- Acronym
- CaNS
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No