Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 6:22 AM
Study NCT ID:
NCT04338334
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2020-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Cohesive Bandage on Axillary Web Syndrome After
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-18', 'studyFirstSubmitDate': '2020-04-04', 'studyFirstSubmitQcDate': '2020-04-04', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Subjective pain', 'timeFrame': '4 assessments to evaluate change from baseline: at baseline, after the intervention period (6 weeks from baseline), 3 and 6 months after the intervention.', 'description': 'Visual Analogue Scale (0-10 cm)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Range of shoulder motion', 'timeFrame': '4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.', 'description': 'Inclinometer (measured in grades)'}, {'measure': 'Change from baseline in perceived shoulder disability', 'timeFrame': '4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.', 'description': 'Oxford Shoulder Score. The OSS is a unidimensional score comprising 12 questions about pain and disability involving activities of daily routine. Thus, each of the 12 questions is scored from 0 to 4, with 4 representing best outcome/least symptoms. Scores from each question are summed so the overall score run from 0 to 48 with 48 being the best outcome; so that the lower scores indicate more pain and disability. The OSS Spanish version is applicable, reliable, valid, and responsive to assess shoulder disability in Spanish women after breast cancer treatment'}, {'measure': 'Change from baseline in QoL', 'timeFrame': '4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.', 'description': 'FACTB+4. Health-related quality of life (HRQoL): HRQoL was measured with the Functional Assessment of Cancer Therapy-Breast (FACT-B) Spanish version 4. FACT-Bv4 is a 40-item questionnaire designed to measure multidimensional HRQoL in women with breast cancer. The 40 items cover four generic scales of well-being (Physical, Emotional, Social, and Functional) and two side-specific subscales: Breast Cancer (9 items) and Arm (4 items). The Arm-specific subscale assesses arm morbidity: 1) pain, 2) poor range of arm movements, 3) numbness, and 4) stiffness. The Breast Cancer subscale plus the arm subscale range from 0 to 56 points. The Trial Outcome Index (TOI) is the sum of Physical and Functional wellbeing plus Breast Cancer Subscale (range 0-92 points). The FACT-B total score can range from 0 to 144, with a higher score indicating better HRQoL.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cohesive bandage', 'Physical Therapy', 'Pain'], 'conditions': ['Axillary Web Syndrome']}, 'descriptionModule': {'briefSummary': 'Objective: To determine the effectiveness of cohesive bandage on the axillary web syndrome in improving pain, reducing swelling and increasing mobility and functionality of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 and 6 months post-intervention post-intervention. Participants: 90 consecutive women diagnosed with axillary web syndrome after undergoing unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two groups by EpiData 3.1 software. Interventions: Control group: Physical Therapy composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active arm therapeutic exercises; Intervention group: progressive active arm therapeutic exercises with cohesive bandage.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral breast cancer;\n* Breast surgery with lymphadenectomy and / or sentinel lymph node biopsy;\n* Axillary web syndrome in upper limb of the operated side;\n* Consent to participate in the study;\n* No contraindications.\n\nExclusion Criteria:\n\n* Cognitive impairment;\n* Visual impairment for reading;\n* Lymphedema;\n* Bilateral breast cancer;\n* Systemic disease (metastases),\n* Infection;\n* Locoregional recurrence.'}, 'identificationModule': {'nctId': 'NCT04338334', 'acronym': 'CBaws', 'briefTitle': 'Effectiveness of Cohesive Bandage on Axillary Web Syndrome After', 'organization': {'class': 'OTHER', 'fullName': 'University of Alcala'}, 'officialTitle': 'Effectiveness of Cohesive Bandage on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OE20/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CONTROL GROUP', 'description': 'Control group includes physical therapy protocol composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active arm therapeutic exercises.', 'interventionNames': ['Other: Manual drainage & arm therapeutic exercise']}, {'type': 'EXPERIMENTAL', 'label': 'COHESIVE BANDAGE GROUP', 'description': 'Cohesive bandage is a self-adherent lightweight bandage, made of a porous nonwoven polyester material. A single self-adherent inelastic bandage will be directly applied at full stretch on cleaned and dried skin (10cm 3M CobanTM Minnesota Mining and Manufacturing Co, United States) in a spiral method around the limb, starting at the hand and a layer overlap of 50%, so that the greatest compression was located at the distal points, gradually decreasing toward the proximal shoulder part. Cohesive latex-free bandages will be available for those allergic women. Women will do progressive active arm therapeutic exercises with bandaging.', 'interventionNames': ['Other: Cohesive bandaging & arm therapeutic exercise']}], 'interventions': [{'name': 'Manual drainage & arm therapeutic exercise', 'type': 'OTHER', 'description': 'See arm/group descriptions.', 'armGroupLabels': ['CONTROL GROUP']}, {'name': 'Cohesive bandaging & arm therapeutic exercise', 'type': 'OTHER', 'description': 'See arm/group descriptions.', 'armGroupLabels': ['COHESIVE BANDAGE GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28005', 'city': 'Alcalá de Henares', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'María Torres-Lacomba, PhD', 'role': 'CONTACT', 'email': 'maria.torres@uah.es', 'phone': '678900061'}, {'name': 'Beatriz Navarro-Brazález, PhD', 'role': 'CONTACT', 'email': 'b.navarrobrazalez@gmail.com'}, {'name': 'Beatriz Arranz Martín, MsC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'María Torres-Lacomba', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}], 'centralContacts': [{'name': 'María Torres-Lacomba, PhD', 'role': 'CONTACT', 'email': 'maria.torres@uah.es', 'phone': '+34678900061'}, {'name': 'Beatriz Navarro-Brazález, PhD', 'role': 'CONTACT', 'email': 'b.navarrobrazalez@gmail.com'}], 'overallOfficials': [{'name': 'María Torres-Lacomba, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alcalá'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alcala', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator & Professor', 'investigatorFullName': 'Maria Torres Lacomba', 'investigatorAffiliation': 'University of Alcala'}}}}