Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 7:54 PM
Study NCT ID:
NCT07305259
Status:
RECRUITING
Last Update Posted:
2025-12-26
First Post:
2025-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Researching Economical Adjuvants to Cancer Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D047071', 'term': 'beta-Glucans'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-12-12', 'lastUpdatePostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cellular Cytotoxicity Assessed With Flow Cytometry', 'timeFrame': 'At baseline, the end of treatment at four weeks, and at eight weeks after a washout phase.', 'description': 'The ability of participant peripheral blood mononuclear cells (PBMCs) to kill target cancers cells in vitro. PBMCs will be co-cultured with cancer cells for four hours, and the number of cancer cells killed over time will be quantified with flow cytometry (e.g., CD71+ labeled cancer cells with compromised cell membranes).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Beta-glucan', 'exercise', 'immune system', 'cancer'], 'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if beta-glucan (a dietary fiber) improves the function of the immune system in adults. It will also tell the investigators if combining beta-glucan with single bouts of exercise provides additional benefit. The main questions it aims to answer are:\n\n1. Does beta-glucan change the ability of immune cells to recognize cancer cells?\n2. Does exercise change the type of immune cells in the blood? Researchers will compare beta-glucan to a placebo (a look-alike substance with no effect) to see if beta-glucan could improve immune function against cancer.\n\nParticipants will:\n\n1. Take beta-glucan or a placebo daily for 4 weeks.\n2. Visit the laboratory for three exercise tests.\n3. Provide blood samples so researchers can study immune system cells.', 'detailedDescription': 'This investigation is a randomized, placebo-controlled trial seeking to determine the extent to which acute exercise and dietary β-glucan supplementation can augment immune responses against cancer. The investigators will mechanistically determine the receptor-ligand interactions between effector lymphocytes and target cancer cells, as well as assess multiple immunotherapies alongside the intervention (e.g., ipilimumab, pembrolizumab, monalizumab). Incorporating lifestyle medicine is well known to improve patient quality of life, and early evidence suggests it may favorably impact overall survival. It is crucial that the investigators harness the immunological potential of lifestyle interventions to broadly improve immunotherapy effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physically fit enough to engage in maximal exercise.\n\nExclusion Criteria:\n\n* BMI \\> 40 kg/m2\n* Stage 2 hypertension (140/90 mmHg)\n* Type I or II diabetes\n* Autoimmune diseases\n* Overt cardiovascular, respiratory, or neurological disease (e.g., previous heart attack, pacemaker, heart failure, asthma)\n* Hormone replacement therapy (e.g., androgens, estrogens)\n* Daily medication usage that may affect immune function (e.g., beta blockers, NSAIDs, corticosteroids, allergy medications)\n* Current antibiotic use\n* Heavy alcohol usage (\\>2 drinks per day)\n* Tobacco use within the last 6 months\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Self-reported pregnancy\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT07305259', 'acronym': 'REACT', 'briefTitle': 'Researching Economical Adjuvants to Cancer Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Researching Economical Adjuvants to Cancer Therapy', 'orgStudyIdInfo': {'id': '00005291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beta-glucan', 'description': '375mg of beta-glucan is provided daily for 4 weeks.', 'interventionNames': ['Dietary Supplement: Beta-glucan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '375mg of cellulose daily for 4 weeks.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Beta-glucan', 'type': 'DIETARY_SUPPLEMENT', 'description': '375mg of beta-glucan in the form of a ground mushroom powder. The supplement is provided in capsule form.', 'armGroupLabels': ['Beta-glucan']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '375mg of microcrystalline cellulose in capsule form.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32306', 'city': 'Tallahassee', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kyle A Smith, PhD, RD', 'role': 'CONTACT', 'email': 'k.smith@fsu.edu', 'phone': '8506451016'}, {'name': 'Kyle A Smith, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Sports Sciences and Medicine', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}], 'centralContacts': [{'name': 'Kyle A Smith, PhD, RD', 'role': 'CONTACT', 'email': 'k.smith@fsu.edu', 'phone': '850-644-1016'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kyle Smith', 'investigatorAffiliation': 'Florida State University'}}}}