Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT01751893
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2012-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Effectiveness of Henna on Managing PPE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060831', 'term': 'Hand-Foot Syndrome'}], 'ancestors': [{'id': 'D003875', 'term': 'Drug Eruptions'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005090', 'term': 'lawsone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-23', 'studyFirstSubmitDate': '2012-12-14', 'studyFirstSubmitQcDate': '2012-12-17', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from Baseline Activities of daily living at 3,4,5,6 weeks', 'timeFrame': '3, 4, 5 and 6 weeks', 'description': 'The ability of the patients to respond to their activities of daily living will be assessed with the Eastern Co-operative Oncology Group (ECOG)/WHO system'}, {'measure': 'Treatment side-effects', 'timeFrame': 'During the 4 weeks', 'description': 'The patients will report any possible side-effect due to the treatment (i.e rash)'}], 'primaryOutcomes': [{'measure': 'Change from Baseline PPE Grade at 3,4, 5,6 weeks', 'timeFrame': '3, 4, 5 and 6 weeks', 'description': 'The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline EORTC QOLc30 at 3,4, 5,6 weeks', 'timeFrame': '3, 4,5 and 6 weeks', 'description': 'The quality of life of the patients will be assessed with the EORTC QOLc30 module which has been developed and validated explicitly for patients suffering from cancer.'}, {'measure': 'Change from Baseline Hand-foot syndrome 14 (HFS-14) at 3,4,5,6 weeks', 'timeFrame': '3, 4, 5 and 6 weeks', 'description': 'this is a quality of life scale for patients experiencing radiation-induced PPE'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hand-foot syndrome', 'palmar-plantar erythrodysesthesia', 'capecitabine', 'pegylated liposomal doxorubicin', 'henna'], 'conditions': ['Palmar-plantar Erythrodysesthesia (PPE)']}, 'referencesModule': {'references': [{'pmid': '33626423', 'type': 'DERIVED', 'citation': "Stavrinou M, Tsitsi T, Astras G, Paikousis L, Charalambous A. A randomised controlled feasibility trial to evaluate Lawsonia inermis (henna)'s effect on palmar-plantar erythrodysesthesia induced by capecitabine or pegylated liposomal doxorubicin. Eur J Oncol Nurs. 2021 Apr;51:101908. doi: 10.1016/j.ejon.2021.101908. Epub 2021 Feb 15."}]}, 'descriptionModule': {'briefSummary': 'The palmar-plantar erythrodysesthesia (PPE) is the only clinical adverse event that commonly occurs with capecitabine and/or pegylated liposomal doxorubicin treatment and it warrants special attention because it is the most common dose-limiting toxicity. this study is designed to test the effectiveness of a henna treatment protocol in the management of capecitabine and/or pegylated liposomal doxorubicin induced palmar-plantar erythrodysesthesia.', 'detailedDescription': 'This will be a randomized double-blind, placebo-controlled study with 80 cancer patients that will receive chemotherapy treatment with capecitabine and/or pegylated liposomal doxorubicin. The selection of potential participants will be based on pre-determined inclusion and exclusion criteria. Patients will be randomly allocated either to the treatment group or the placebo group. Treatment will be delivered twice a week and assessments will take place at 2, 3, 4, 5 and 6 weeks.\n\nThe intervention group will receive the application of henna to the hands and/or feet of the patients and the control group will receive the placebo.\n\nAt both baseline and follow-up, patients in both groups will be assessed for their degree of palmar-plantar erythrodysesthesia, the Quality of Life, the need for dose-limiting due to PPE and Pain intensity using standardized rating scales. Data will be analysed with inferential and descriptive statistics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult cancer patients (\\>18)\n* Patients receiving capecitabine and/or PLD as monotherapy or in combination with other agents\n* Patients that will experience PPE grade 1 or above\n* Willing to participate\n* Ability to complete the psychometric assessments.\n* A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG)\n\nExclusion Criteria:\n\n* Patients with hypersensitivity to natural henna.\n* Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results\n* Patients on Pyridoxine or nicotine patches\n* Patients with a previous history of PPE\n* Patients whose chemotherapy was discontinued for more than a week'}, 'identificationModule': {'nctId': 'NCT01751893', 'briefTitle': 'Testing the Effectiveness of Henna on Managing PPE', 'organization': {'class': 'OTHER', 'fullName': 'Cyprus University of Technology'}, 'officialTitle': 'A Randomized Double-blind, Placebo-controlled Study of the Effects of Lawsonia Inermis on Palmar-Plantar Erythrodysesthesia Induced by Capecitabine and/or Pegylated Liposomal Doxorubicin', 'orgStudyIdInfo': {'id': 'AC-PPEHP-88'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Henna arm', 'description': 'Based on the treatment protocol for this study the patients will receive the henna treatment for 4 weeks (supervised treatment for first week and then unsupervised sessions twice a week). The treatment will include the application of the henna mixture (paste) (40gr natural henna and 40ml of purified water) to the affected areas (feet or/and hands) and wear socks or/and gloves. The treatment session will last for 1 hour and then the mixture will be rinsed with fresh water.', 'interventionNames': ['Drug: Henna']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Based on the treatment protocol for this study the patients in this arm will receive the henna placebo treatment for 4 weeks (supervised treatment for first week and then unsupervised sessions twice a week). The treatment will include the application of the henna placebo mixture (paste) (40gr placebo henna and 40ml of purified water) to the affected areas (feet or/and hands) and wear socks or/and gloves. The treatment session will last for 1 hours and then the mixture will be rinsed with fresh water.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Henna', 'type': 'DRUG', 'description': 'natural henna in the form of paste', 'armGroupLabels': ['Henna arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2047', 'city': 'Nicosia', 'country': 'Cyprus', 'facility': 'American Medical Centre', 'geoPoint': {'lat': 35.17284, 'lon': 33.35397}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cyprus University of Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Oncology and Palliative Care', 'investigatorFullName': 'Dr. Andreas Charalambous', 'investigatorAffiliation': 'Cyprus University of Technology'}}}}