Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05410002
Status:
COMPLETED
Last Update Posted:
2024-10-03
First Post:
2022-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diet Effect on Cancer Treatment Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Active product (N-111) and placebo will be in identical packets with the contents of identical weight, color and texture.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized interventional parallel study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-01', 'studyFirstSubmitDate': '2022-06-04', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Active Comparator: Vegetarian N-111 group', 'timeFrame': 'End of month 3.', 'description': 'Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.'}, {'measure': 'Active Comparator: Non-vegetarian N-111 group.', 'timeFrame': 'End of month 3.', 'description': 'Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.'}], 'secondaryOutcomes': [{'measure': 'Placebo Comparator: Vegetarian placebo group', 'timeFrame': 'End of month 3.', 'description': 'Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.'}, {'measure': 'Placebo Comparator: Non-vegetarian placebo control group', 'timeFrame': 'End of month 3.', 'description': 'Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer'], 'conditions': ['Cancer Breast', 'Cancer Prostate']}, 'descriptionModule': {'briefSummary': 'The study will look at the end result of 2 types of diets effect on treatment outcome of cancer patients using N-111.', 'detailedDescription': 'The study will be evaluated during a double blind, placebo-controlled evaluation of the effect diet has on the response of patients taking N-111 who are on a vegetarian diet vs a non-vegetarian diet or a placebo. This will involve assessing the patients progress or lack thereof over a 3-month period of time as outlined in Outcome Measures section below.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A positive diagnosis of breast cancer as determined by Fine Needle Biopsy or open biopsy with associated Cancer Antigen blood markers.\n* Prostate cancer as determined by a Transrectal Biopsy with associated Prostate- specific antigen blood work.\n\nExclusion Criteria:\n\n* •Patients without the positive diagnosis of breast or prostate cancer.'}, 'identificationModule': {'nctId': 'NCT05410002', 'briefTitle': 'Diet Effect on Cancer Treatment Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Optimal Health Research'}, 'officialTitle': 'A Study on the Effect Diet Has Affecting the Response of Patients Taking N-111 Who Are on a Vegetarian Diet Vs a Non-vegetarian Diet or a Placebo', 'orgStudyIdInfo': {'id': 'N-111012422'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vegetarian N-111 group', 'description': 'The group will use a vegetarian diet with the active compactor N-111.', 'interventionNames': ['Dietary Supplement: Dietary Supplement: N-111']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-vegetarian N-111 group.', 'description': 'The group will use a non-vegetarian diet with the active compactor N-111.', 'interventionNames': ['Dietary Supplement: Dietary Supplement: N-111']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vegetarian placebo group', 'description': 'The group will use a vegetarian diet with a placebo.', 'interventionNames': ['Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-vegetarian placebo control group', 'description': 'The group will use a non-vegetarian diet with a placebo.', 'interventionNames': ['Other: Placebo']}, {'type': 'NO_INTERVENTION', 'label': 'Vegetarian control group', 'description': 'The group will use a vegetarian diet without the active compactor N-111 or the placebo.'}, {'type': 'NO_INTERVENTION', 'label': 'Non-vegetarian control group', 'description': 'he group will use a non-vegetarian diet without the active compactor N-111 or the placebo.'}], 'interventions': [{'name': 'Dietary Supplement: N-111', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary supplement N-111', 'armGroupLabels': ['Non-vegetarian N-111 group.', 'Vegetarian N-111 group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Dietary placebo', 'armGroupLabels': ['Non-vegetarian placebo control group', 'Vegetarian placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Optimal Health Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '590010', 'city': 'Belagāve', 'state': 'Karnataka', 'country': 'India', 'facility': 'KLE Academy of Higher Education & Research', 'geoPoint': {'lat': 14.39918, 'lon': 75.2413}}, {'zip': '400028', 'city': 'Mumbai', 'country': 'India', 'facility': 'Indian Institute of Research', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}], 'overallOfficials': [{'name': 'EA Jeppsen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Optimal Health Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optimal Health Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}