Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-13 @ 7:46 AM
Study NCT ID:
NCT00559858
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
2007-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D060831', 'term': 'Hand-Foot Syndrome'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D003875', 'term': 'Drug Eruptions'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D004342', 'term': 'Drug Hypersensitivity'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011736', 'term': 'Pyridoxine'}], 'ancestors': [{'id': 'D025101', 'term': 'Vitamin B 6'}, {'id': 'D010847', 'term': 'Picolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2007-11-15', 'studyFirstSubmitQcDate': '2007-11-15', 'lastUpdatePostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity'}], 'secondaryOutcomes': [{'measure': 'Incidence of hand-foot syndrome (HFS)'}, {'measure': 'Overall toxicity'}, {'measure': 'Quality of life'}, {'measure': 'Response to chemotherapy'}, {'measure': 'Progression-free survival'}, {'measure': 'Measurement of biomarkers that might predict the occurrence of HFS'}]}, 'conditionsModule': {'keywords': ['palmar-plantar erythrodysesthesia', 'breast cancer', 'male breast cancer', 'colon cancer', 'rectal cancer'], 'conditions': ['Breast Cancer', 'Colorectal Cancer', 'Palmar-plantar Erythrodysesthesia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome.\n\nPURPOSE: This phase III randomized trial is studying pyridoxine to see how well it works compared to a placebo in preventing hand-foot syndrome in patients who are receiving capecitabine for advanced colorectal cancer or breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine whether pyridoxine can reduce the incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity.\n\nSecondary\n\n* Determine the incidence of hand-foot syndrome (HFS).\n* Determine the overall toxicity.\n* Determine the quality of life.\n* Determine the response to chemotherapy.\n* Determine the progression-free survival.\n* Determine the level of biomarkers which might predict the occurrence of HFS.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to disease (breast cancer vs colorectal cancer). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral pyridoxine hydrochloride 3 times daily beginning with the initiation of capecitabine chemotherapy and continuing until completion of chemotherapy.\n* Arm II: Patients receive oral placebo 3 times daily beginning with the initiation of capecitabine chemotherapy and continuing until completion of chemotherapy.\n\nIn both arms, treatment continues in the absence of disease progression or unacceptable toxicity.\n\nEvidence of hand-foot syndrome is assessed at baseline and before each course of capecitabine. Quality of life is assessed at baseline and then every 6 weeks.\n\nAfter completion of study treatment, patients are followed at 6 and 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of advanced colorectal or breast carcinoma\n\n * Hormone receptor status not specified\n* Receiving single-agent capecitabine chemotherapy\n* Measurable disease for response assessment, determined on an individual patient basis, using conventional clinical and/or radiological methods\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Menopausal status not specified\n* Life expectancy ≥ 12 weeks\n* Hemoglobin ≥ 10 g/dL\n* Platelet count ≥ 100,000 mm\\^3\n* WBC ≥ 3,000/mm\\^3\n* ANC ≥ 1,500/mm\\^3\n* Bilirubin ≤ 1.3 x upper limit of normal (ULN)\n* Alkaline phosphatase ≤ 5 x ULN\n* AST and ALT ≤ 5 x ULN\n* Creatinine ≤ 1.5 x ULN\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after completion of study treatment\n* No other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial\n* No medical or psychiatric condition which would influence the ability to provide informed consent\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* At least 6 weeks since prior investigational agents\n* Concurrent radiotherapy allowed\n* No other concurrent chemotherapy or immunotherapy\n* No concurrent nonsteroidal anti-inflammatory drugs NSAIDs) for the primary purpose of treating hand-foot syndrome (HFS) or cancer\n\n * NSAIDs for conditions other than HFS or cancer allowed'}, 'identificationModule': {'nctId': 'NCT00559858', 'briefTitle': 'Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome', 'orgStudyIdInfo': {'id': 'CRCA-CCTC-CAPP-IT'}, 'secondaryIdInfos': [{'id': 'CDR0000576453', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EUDRACT-2004-000325-29'}, {'id': 'EU-20786'}, {'id': 'ISRCTN82842634'}, {'id': 'CCLG-CAPP-IT'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'pyridoxine hydrochloride', 'type': 'DIETARY_SUPPLEMENT'}, {'name': 'placebo', 'type': 'OTHER'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SS16 5NL', 'city': 'Basildon', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Basildon University Hospital', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'zip': 'MK42 9DJ', 'city': 'Bedford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Primrose Oncology Unit', 'geoPoint': {'lat': 52.13459, 'lon': -0.46632}}, {'zip': 'IP33 2QZ', 'city': 'Bury St Edmunds', 'state': 'England', 'country': 'United Kingdom', 'facility': 'West Suffolk Hospital', 'geoPoint': {'lat': 52.2463, 'lon': 0.71111}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CT2 7NR', 'city': 'Canterbury', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Kent and Canterbury Hospital', 'geoPoint': {'lat': 51.27904, 'lon': 1.07992}}, {'zip': 'DE1 2QY', 'city': 'Derby', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Derbyshire Royal Infirmary', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'EX2 5DW', 'city': 'Exeter', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter Hospital', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'PE30 4ET', 'city': 'Kings Lynn', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.75172, 'lon': 0.39516}}, {'zip': 'WN1 2NN', 'city': 'Lancanshire', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Albert Edward Infirmary'}, {'zip': 'ME16 9QQ', 'city': 'Maidstone', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Mid Kent Oncology Centre at Maidstone Hospital', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'zip': 'PE3 6DA', 'city': 'Peterborough', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Peterborough Hospitals Trust', 'geoPoint': {'lat': 52.57364, 'lon': -0.24777}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'TN4 8AT', 'city': 'Royal Tunbridge Wells', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Kent and Sussex Hospital', 'geoPoint': {'lat': 51.13321, 'lon': 0.26256}}, {'zip': 'SN3 6BB', 'city': 'Swindon', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Great Western Hospital', 'geoPoint': {'lat': 51.55797, 'lon': -1.78116}}, {'zip': 'WS2 9PS', 'city': 'Walsall', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Walsall Manor Hospital', 'geoPoint': {'lat': 52.58528, 'lon': -1.98396}}, {'zip': 'SS0 0RY', 'city': 'Westcliff-on-Sea', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southend University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.54424, 'lon': 0.69179}}], 'overallOfficials': [{'name': 'Pippa Corrie, PhD, FRCP', 'role': 'STUDY_CHAIR', 'affiliation': 'Cambridge University Hospitals NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}}}}