Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-27 @ 10:46 AM
Study NCT ID:
NCT05137067
Status:
COMPLETED
Last Update Posted:
2025-03-21
First Post:
2021-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Approach for Alleviating the Side Effects of Chemotherapeutic Agents.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Active product and placebo will be in identical packets.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized interventional parallel study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2021-04-11', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PROMIS (Patient-Reported Outcomes Measurement Information System) Global 10 Health Questionnaire to assess change from baseline.', 'timeFrame': 'Once a week for 3 months', 'description': 'A summary indicator of health status by assessing 5 domains: physical function, fatigue, pain, emotional distress, and social health to assess change from baseline for improvement or decline.'}, {'measure': 'Symptom Assessment Questionnaire to assess change from baseline.', 'timeFrame': 'Once a week for 3 months', 'description': 'A symptom is a sensation or perception of change related to health function experienced by an individual. Symptoms such as fatigue, pain and nausea can be classified according to their severity and perceived impact on function as a change from baseline for improvement or decline.'}], 'secondaryOutcomes': [{'measure': 'Cancer antigens blood markers to assess change from baseline.', 'timeFrame': 'Once a week for 3 months.', 'description': 'Breast: CA 27.29, serial monitor report; carcinoembryonic antigen (CEA), serial monitor report; lipid-associated sialic acid (LASA), serial monitor report. Lung: Carcinoembryonic antigen (CEA), serial monitor report; lipid-associated sialic acid (LASA), serial monitor report; neuron-specific enolase (NSE), serial monitor report. Prostate: Prostate-specific antigen (PSA), serial monitor report; prostatic acid phosphatase (PAP), serial monitor report as a change from baseline for improvement or decline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer Breast Lung Prostate'], 'conditions': ['Breast Cancer', 'Lung Cancer', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients.', 'detailedDescription': 'This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients. The study will be observing the standard treatment protocol for any degradation or enhancement due to the nutraceutical.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'Breast cancer: Female only\n\nLung cancer: Both Female and Male\n\nProstate cancer: Male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nActive breast cancer patients taking one of the studies listed drugs within the age range.\n\nActive lung cancer patients taking one of the studies listed drugs within the age range.\n\nActive prostate cancer patients taking one of the studies listed drugs within the age range.\n\n\\-\n\nExclusion Criteria:\n\nAnyone without the three types of cancer (breast cancer, lung cancer, prostate cancer) listed in inclusion criteria.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05137067', 'briefTitle': 'A Novel Approach for Alleviating the Side Effects of Chemotherapeutic Agents.', 'organization': {'class': 'OTHER', 'fullName': 'Optimal Health Research'}, 'officialTitle': 'Effectiveness of RaproCell in Alleviating the Side Effects of Chemotherapeutic Agents, Without Adversely Impacting the Overall Success of the Agents on Cancer Cells.', 'orgStudyIdInfo': {'id': 'RPC006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Chemotherapeutic agent A (Docetaxel)', 'description': 'The patients with breast cancer will receive chemotherapeutic agent A', 'interventionNames': ['Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Chemotherapeutic agent A (Docetaxel) plus placebo', 'description': 'The patients with breast cancer will receive chemotherapeutic agent A plus a placebo.', 'interventionNames': ['Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapeutic agent A (Docetaxel) plus RaproCell', 'description': 'The patients with breast cancer will receive chemotherapeutic agent A plus RaproCell.', 'interventionNames': ['Dietary Supplement: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)']}, {'type': 'OTHER', 'label': 'Chemotherapeutic agent B (Cisplatin)', 'description': 'The patients with lung cancer will receive Chemotherapeutic agent B', 'interventionNames': ['Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Chemotherapeutic agent B (Cisplatin) plus placebo', 'description': 'The patients with lung cancer will receive Chemotherapeutic agent B plus placebo.', 'interventionNames': ['Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapeutic agent B (Cisplatin) plus RaproCell', 'description': 'The patients with lung cancer will receive Chemotherapeutic agent B plus RaproCell.', 'interventionNames': ['Dietary Supplement: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)']}, {'type': 'OTHER', 'label': 'Chemotherapeutic agent C (Docetaxel)', 'description': 'The patients with prostate cancer will receive Chemotherapeutic agent C', 'interventionNames': ['Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Chemotherapeutic agent C (Docetaxel) plus placebo', 'description': 'The patients with prostate cancer will receive Chemotherapeutic agent C plus placebo.', 'interventionNames': ['Drug: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapeutic agent C plus (Docetaxel) RaproCell', 'description': 'The patients with prostate cancer will receive Chemotherapeutic agent C plus RaproCell.', 'interventionNames': ['Dietary Supplement: Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)']}], 'interventions': [{'name': 'Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus Dietary Supplement (RaproCell)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['RaproCell'], 'description': 'Chemotherapeutic side effect elimination without adversely effecting the Chemotherapeutic agent drug.', 'armGroupLabels': ['Chemotherapeutic agent A (Docetaxel) plus RaproCell', 'Chemotherapeutic agent B (Cisplatin) plus RaproCell', 'Chemotherapeutic agent C plus (Docetaxel) RaproCell']}, {'name': 'Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel) plus placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Chemotherapeutic agent A (Docetaxel) plus placebo', 'Chemotherapeutic agent B (Cisplatin) plus placebo', 'Chemotherapeutic agent C (Docetaxel) plus placebo']}, {'name': 'Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).', 'type': 'DRUG', 'description': 'Chemotherapeutic agent A(Docetaxel),B(Cisplatin) or C(Docetaxel).', 'armGroupLabels': ['Chemotherapeutic agent A (Docetaxel)', 'Chemotherapeutic agent B (Cisplatin)', 'Chemotherapeutic agent C (Docetaxel)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Optimal Health Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'EA Jeppsen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Optimal Health Clinic'}, {'name': 'Steven Osguthorpe, ND', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Optimal Health Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optimal Health Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}