Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-01-02 @ 12:45 AM
Study NCT ID:
NCT06326268
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Light Therapy in Hematology - The PHOTO-TREAT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis', 'timeFrame': 'Up to 12 weeks', 'description': 'Rate of occurrence of mucositis, graded according to NCI-CTCAE V5.0 criteria'}], 'secondaryOutcomes': [{'measure': 'Evaluate the impact of PBM in the management of chemo-induced mucositis in terms of reduction in analgesic consumption.', 'timeFrame': 'Up to 12 weeks', 'description': 'Consumption of level III analgesics during aplasia after chemotherapy.'}, {'measure': 'Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction.', 'timeFrame': 'Up to 12 weeks', 'description': 'Consumption of systemic anti-infectives during aplasia after induction and conditioning chemotherapy.'}, {'measure': 'Evaluate the impact of PBM in terms of reduction of the use of artificial feeding.', 'timeFrame': 'Up to 12 weeks', 'description': 'Duration of artificial nutrition during aplasia'}, {'measure': 'Evaluate the impact of PBM in terms of reduction of the length of hospital stay.', 'timeFrame': 'Up to 12 weeks', 'description': 'Length of hospitalization'}, {'measure': 'Evaluate the impact of PBM in terms of reduction of the number of transfusions.', 'timeFrame': 'Up to 12 weeks', 'description': 'Number of transfusions during hospitalization'}, {'measure': 'Evaluate the impact of PBM in terms of pain reduction', 'timeFrame': 'Up to 12 weeks', 'description': 'Assessment using a visual analogue scale (VAS, graded from 0 to 10). Measurement before and after each PBM session.'}, {'measure': "Evaluate the impact of PBM on patient's satisfaction regarding pain management during hospital stay", 'timeFrame': 'Up to 12 weeks', 'description': 'Evaluation of patient satisfaction with the hospital stay - questions on pain management from the Picker Patient Experience Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leukemia, Myeloid, Acute', 'Lymphoma']}, 'referencesModule': {'references': [{'pmid': '38439757', 'type': 'BACKGROUND', 'citation': 'Buclin CP, Uribe A, Daverio JE, Iseli A, Siebert JN, Haller G, Cullati S, Courvoisier DS. Validation of French versions of the 15-item picker patient experience questionnaire for adults, teenagers, and children inpatients. Front Public Health. 2024 Feb 19;12:1297769. doi: 10.3389/fpubh.2024.1297769. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'Chemo-induced mucositis is a common complication in patients treated for hematologic malignancies. They can manifest itself as a simple local irritation with erythema and inflammation but can also progress to erosions and ulcerations of the entire oral mucosa and are also responsible for an increased risk of infection in these immunocompromised patients.\n\nThe only therapies currently offered are local care and intravenous analgesics. Studies in pediatric hematology show the effectiveness of prevention and low-dose laser treatment in chemo-induced mucositis, both in terms of reducing the number of mucositis developed but also in terms of reducing the grade of mucositis. This currently results in a recommendation for the use of photobiomodulation by international bodies such as ESMO (European Society for Medical Oncology).', 'detailedDescription': 'During this research, the investigators aim at validating the efficacy and impact of photo-biomodulation in the management of chemo-induced mucositis in hematology department of Strasbourg Cancer Institute (ICANS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient;\n* Patients:\n\nIn induction of acute myeloblastic leukemia OR Allografts in first remission with myeloablative conditioning OR Autografts in the context of aggressive lymphoma;\n\n* Signature of informed consent;\n* Patient registered with social security.\n\nExclusion Criteria:\n\n* Patient under guardianship or curatorship\n* Pregnant and breastfeeding woman\n* Allergy to polyurethanes'}, 'identificationModule': {'nctId': 'NCT06326268', 'acronym': 'PHOTO-TREAT', 'briefTitle': 'Interest of Light Therapy in Hematology - The PHOTO-TREAT Study', 'organization': {'class': 'OTHER', 'fullName': 'Institut de cancérologie Strasbourg Europe'}, 'officialTitle': 'Validation of the Improvement in the Management of Chemo-induced Mucositis in Hematology Through the Contribution of Photobiomodulation - The PHOTO-TREAT Study', 'orgStudyIdInfo': {'id': '2023-019'}, 'secondaryIdInfos': [{'id': '2023-A02133-42', 'type': 'OTHER', 'domain': 'ID-RCB Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Photobiomodulation', 'description': '• Patients: In induction of acute myeloblastic leukemia OR Allografts in first remission with myeloablative conditioning OR Autografts in the context of aggressive lymphoma;', 'interventionNames': ['Device: Phototherapy system CareMin650TM']}], 'interventions': [{'name': 'Phototherapy system CareMin650TM', 'type': 'DEVICE', 'description': '* As part of preventive treatment: Photobiomodulation sessions will be carried out at a dose of 3 joules for 1 minute 51 seconds, 3 times a week (for a maximum duration of 4 to 6 weeks).\n* As part of curative treatment (i.e. for patients developing mucositis, from grade I): photobiomodulation will be carried out at a curative dose of 6 joules daily (for a maximum duration of 4 to 6 weeks ) for 3 minutes 34 seconds.', 'armGroupLabels': ['Photobiomodulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67033', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'role': 'CONTACT', 'email': 'promotion-rc@icans.eu', 'phone': '(0)3 68 33 95 23', 'phoneExt': '+33'}, {'name': 'Anne ZILLIOX, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut de cancérologie Strasbourg Europe', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Claire VIT', 'role': 'CONTACT', 'email': 'promotion-rc@icans.eu', 'phone': '(0)3 68 33 95 23', 'phoneExt': '+33'}, {'name': 'Manon VOEGELIN', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Anne ZILLIOX, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de cancérologie Strasbourg Europe'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de cancérologie Strasbourg Europe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}