Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-20 @ 11:25 AM
Study NCT ID:
NCT02036957
Status:
UNKNOWN
Last Update Posted:
2016-08-02
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MARY DUOL REPAIR BALM IN THE PREVENTION OR REDUCING ANTINEOPLASIC AGENTS' SKIN TOXICITY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003875', 'term': 'Drug Eruptions'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004342', 'term': 'Drug Hypersensitivity'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-01', 'studyFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients who develop dermatologic toxicity.', 'timeFrame': '3 moths', 'description': 'Compare the percentage of patients who develop dermatologic toxicity in any grade (1-5) between intervention and control group at three months of starting treatment, through CTCAE scale (National Cancer Institute Common Toxicity Criteria).'}], 'secondaryOutcomes': [{'measure': 'Need of pharmacological treatment to mitigate toxicity', 'timeFrame': '3 months', 'description': 'Compare the percentage of patients in both groups who required pharmacological treatment to mitigate the dermatologic toxicity produced by chemotherapy'}, {'measure': 'Quality of life', 'timeFrame': '3 months', 'description': 'Compare the quality of life in both groups at three months, through the Skindex 29 scale to evaluate the quality of life due to skin disease.'}, {'measure': 'Percentaje of patients who have reduces skin toxicity', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['capecitabine', 'dermatologic toxicity'], 'conditions': ['Dermatitis, Adverse Drug Reaction']}, 'descriptionModule': {'briefSummary': "Capecitabine is a drug that produces dermatologic toxicity frequently (palmoplantar erythrodysesthesia, rash , alopecia , erythema , dryness, pruritus, hyperpigmentation , rash, peeling , dermatitis , abnormal pigmentation, and less often blistering, skin ulcers , photosensitivity reactions, swelling of the face and purple) . The impact in patients' quality of life is great, so We had decided to conduct a randomized clinical trial to evaluate the effectiveness Mary D' uol balm preventing dermatologic toxicity in patient treated with capecitabine .\n\nDesign: Randomized clinical trial phase II, in parallel and double-blind groups\n\nTarget population : Patients with colon cancer stage II or III ( Dukes' C ) , who will initiate treatment with capecitabine monotherapy.\n\nInclusion criteria: Over 18 years, II or III colon (Dukes' C) colon cancer, primary diagnosis, capecitabine monotherapy, sign the informed consent.\n\nPrimary endpoint: Dermatologic toxicity (yes / no) Statistical analysis: The primary endpoint (percentage of patients that develop dermalogic toxocity in both groups) will be analyzed by a logistics regression model", 'detailedDescription': 'Intervention: Preventive treatment of dermatologic toxicities begin on the day of initiation of treatment with Xeloda, capecitabine + oxaliplatin, Adriamycin Liposomial or cytarabine\n\nThe product will be applied throughout the body in abundant quantities so that the skin is perfectly hydrated. It is applied twice daily (after showering and evening), gently massaging the area until completely absorbed.\n\nThe product will be provided at the unit of oncology pharmacy, when the patient is randomized. 3 packs per cycle will be provided. If not enough (because the patient has greater surface area) will be supplied more. Each time you start a new cycle 3 new packages will be delivered.\n\nThe patient will not apply any other cosmetic product in the treated areas.\n\nIn addition all patients regardless of the group will receive recommendations for reducing the appearance of skin problems caused by these type of drugs.\n\nThe study will have a total duration of 24 weeks (8 cycles of chemotherapy), except in cases of patients requiring a cycle delay for filing toxicity. In these patients the total duration of the study must be sufficient to end the eighth cycle.\n\nIf the side effects are so severe that greatly affect the quality of life of the patient and the doctor thinks fit, may prescribe drug treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years.\n* Sign the informed consent\n\nExclusion Criteria:\n\n* Patients with neoadjuvant treatment.\n* Patients with dermatologic diseases.\n* Patients treated with corticosteroids.'}, 'identificationModule': {'nctId': 'NCT02036957', 'acronym': 'B-DUOL', 'briefTitle': "MARY DUOL REPAIR BALM IN THE PREVENTION OR REDUCING ANTINEOPLASIC AGENTS' SKIN TOXICITY", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Basque Health Service'}, 'officialTitle': "EFFECTIVENESS OF MARY D'UOL REPAIR BALM FOR PREVENTING AND / OR REDUCING TOXICITY SKIN IN PATIENTS WITH CANCER AND TREATMENT WITH ANY Antineoplastic Agent. RANDOM CLINICAL TRIAL.", 'orgStudyIdInfo': {'id': 'MD-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BALM ARM', 'description': 'The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. Will be applied twice a day (after showering and at night), massaging the area until completely absorption.', 'interventionNames': ['Procedure: BALM ARM']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO ARM', 'description': 'It be applicated in like manner that balm arm', 'interventionNames': ['Procedure: PLACEBO ARM']}], 'interventions': [{'name': 'BALM ARM', 'type': 'PROCEDURE', 'description': 'The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption. Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms.', 'armGroupLabels': ['BALM ARM']}, {'name': 'PLACEBO ARM', 'type': 'PROCEDURE', 'description': 'The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption. Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms.', 'armGroupLabels': ['PLACEBO ARM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Álava', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Arantza Saez de Lafuente', 'role': 'CONTACT'}, {'name': 'Carlos Peña', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University hospital of Araba', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}], 'centralContacts': [{'name': 'Patricia Seaone, MD', 'role': 'CONTACT', 'phone': '945007000'}], 'overallOfficials': [{'name': 'Arantza Sáez de la Fuente, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Basque Health Service (Research Unit)'}, {'name': 'Patricia Seaone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Basque Health Service (Research Unit)'}, {'name': 'Raquel Cobos, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Basque Health Service (Research Unit)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basque Health Service', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'oncologist physician', 'investigatorFullName': 'Patricia Seoane', 'investigatorAffiliation': 'Basque Health Service'}}}}