Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT06469216
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2024-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time (in days) to occurrence of Acute Radiation Proctitis', 'timeFrame': 'for each patient: time from the first day of radiation therapy for up to 3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['double blind', 'placebo control', 'Randomized Clinical Trial'], 'conditions': ['Acute Radiation Proctitis', 'Acute Radiation Enteritis']}, 'descriptionModule': {'briefSummary': 'A randomized placebo-controlled clinical trial to evaluate efficacy of hyaluronic acid in prevention of acute radiation proctitis among oncology patient population especially who are diagnosed with abdomeno-pelvic tumors and subsequently required radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients diagnosed with pelvic or gastrointestinal malignancies (tumors in uterus, cervix, prostate, seminal vesicles, kidney, colon, etc.),\n* All patients who required adjuvant or radical radiation therapy;\n* Age \\< 80 years;\n* Karnofsky Performance Status ≥ 60\n\nExclusion Criteria:\n\n* Patients were excluded if they had\n\n * gt; previous pelvic radiotherapy,\n * gt; inflammatory bowel disease or\n * gt; rectal issues (e.g., haemorrhoids).\n* Patients diagnosed with cancer rectum'}, 'identificationModule': {'nctId': 'NCT06469216', 'briefTitle': 'Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Efficacy of Hyaluronic Acid in Prevention of Acute Radiation Proctitis: Multi-center, Double-blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '05-2023-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '30 ml of Hyaluronic Acid (HA) enema will be given to the patients', 'description': 'All patients will be prospectively randomized into two groups; either the treatment (HA) group or the control group. In this study protocol, 30 ml of HA enema and 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to the patients as they lie on their left side with their right knee pulled up to the chest.', 'interventionNames': ['Drug: Hyaluronic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': '30 ml of placebo enema (identical to treatment group enema but without HA) will be given to patients', 'description': 'All patients will be prospectively randomized into two groups; either the treatment (HA) group or the control group. In this study protocol, 30 ml of HA enema and 30 ml of placebo enema (identical to treatment group enema but without HA) will be given to the patients as they lie on their left side with their right knee pulled up to the chest.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Hyaluronic Acid', 'type': 'DRUG', 'otherNames': ['Sodium Hyaluronate'], 'description': 'Hyaluronic Acid to be used as sodium hyaluronate powder plus inactive ingredient (Carboxy methyl cellulose) and to be dissolved in distilled water', 'armGroupLabels': ['30 ml of Hyaluronic Acid (HA) enema will be given to the patients']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Inactive ingredient (Carboxy methyl cellulose) to be used as powder and to be dissolved in distilled water', 'armGroupLabels': ['30 ml of placebo enema (identical to treatment group enema but without HA) will be given to patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '055', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ahmed Maher teaching hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '055', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Al-Ahrar teaching hospital', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical pharmacist at Al-Ahrar Oncology Center', 'investigatorFullName': 'Samar Gamal El Sheikh', 'investigatorAffiliation': 'Assiut University'}}}}