Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-04 @ 3:42 PM
Study NCT ID:
NCT00304850
Status:
COMPLETED
Last Update Posted:
2009-12-29
First Post:
2006-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polyamine-free Diet to Prevent Post Surgery Hyperalgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-24', 'studyFirstSubmitDate': '2006-03-17', 'studyFirstSubmitQcDate': '2006-03-17', 'lastUpdatePostDateStruct': {'date': '2009-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine requirement', 'timeFrame': 'for the 24 postoperative hours'}], 'secondaryOutcomes': [{'measure': 'Pain intensity for the 4 days (and possibly at 7th day if the patient is still hospitalized) after surgery', 'timeFrame': '4 days'}, {'measure': 'Allodynia measurements', 'timeFrame': 'inclusion, 1, 2, 4 and 7 ddays after surgery'}, {'measure': 'Hyperesthesia measurements', 'timeFrame': 'inclusion, 1, 2, 4 and 7 ddays after surgery'}, {'measure': 'Chronic pain incidence', 'timeFrame': '3 and 6 months'}, {'measure': 'Late allodynia and/or hyperesthesia', 'timeFrame': '6 months'}, {'measure': 'safety of treatment', 'timeFrame': 'Along each patient folow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['polyamines', 'pain', 'breast cancer', 'mastectomy', 'post operative pain'], 'conditions': ['Breast Cancer', 'Surgery']}, 'descriptionModule': {'briefSummary': 'After surgery, sensitization and hyperexcitability of central nervous system result in acute and long lasting postoperative pain. It has been shown that N-methyl-D-aspartate (NMDA) receptors antagonist (such as ketamine) prevent this adverse neuroplasticity and potentiate analgesic drugs efficacy. Polyamines (putrescine, spermidine, spermine) are essential components of cells functioning and are also known as allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has confirmed these antinociceptive properties. This research aims at evaluating anti hyperalgesic properties of polyamine-free diet in women operated on breast cancer versus kétamine', 'detailedDescription': 'This multicentric, single blind study will enrol 160 women (18-75 years old) operated on tumorectomy and adenectomy (T1, T2, T3, N0, N1, M0) for breast cancer. Patients will be randomly assigned in a 2x2 factorial plan : Group 1 = control (n = 40) ; group 2 = ketamine group administered during and 48 hours after a standardized anesthesia (n = 40) ; group 3 = polyamine-free diet, 1 week and 72 hours after surgery (n = 40) ; group 4 : ketamine + polyamine-free diet (n = 40).\n\nThe amount of morphine for the 24 first postoperative hours will be compared between each group as well as pain score, allodynia (Von Frey filaments) and hyperalgesia (algometer). Chronic pain occurrence (post-mastectomy pain syndrome) will be evaluated at 3 and 6 months using adequate questionnaire ( analgesic scale). Diet observance will be controlled preoperatively by a dosage of polyamines in circulating red cells blood.\n\nPolyamines deprivation and ketamine ability to reduce postoperative pain will be compared (isobolographic method). Anti-hyperalgesic properties of ketamine have already been demonstrated in urologic, orthopaedic and abdominal surgery. In case of additive or synergistic effect of a polyamine deprivation such a strategic could be helpful to achieve better postoperative rehabilitation in reducing chronic pain after surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer (T1, T2, T3, N0, N1, M0)\n* Age : 18 - 75\n* Asa 1-3\n* left or right tumorectomy with complete lymphadenectomy\n* left or right complete mastectomy with complete lymphadenectomy\n* complete lymphadenectomy within one week following simple tumorectomy\n* informed consent signed\n\nExclusion Criteria:\n\n* inflammatory tumor requiring pre-operative radiotherapy\n* previous history of total mastectomy or partial contralateral mastectomy\n* chronic inflammatory disease treated by corticoids or NSAI\n* chronic analgesic treatment\n* anti-arrhythmic or anti-epileptic treatments\n* morphinic treatment during the 7 days before surgery\n* excessive alcohol consumption or addiction\n* ketamine or neomycin contra-indication\n* severe cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT00304850', 'acronym': 'PoLyDOL', 'briefTitle': 'Polyamine-free Diet to Prevent Post Surgery Hyperalgesia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Efficacy of a Polyamine-free Diet Associated or Not With Ketamine on Early and Late Hyperalgesia After Breast Cancer Surgery', 'orgStudyIdInfo': {'id': '9258-03'}, 'secondaryIdInfos': [{'id': '2002-004'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'R+ / K+', 'interventionNames': ['Behavioral: polyamine-free diet', 'Drug: Ketamine or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'R+ / K-', 'interventionNames': ['Behavioral: polyamine-free diet', 'Drug: Ketamine or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'R- / K+', 'interventionNames': ['Drug: Ketamine or placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'R- /K-', 'interventionNames': ['Drug: Ketamine or placebo']}], 'interventions': [{'name': 'polyamine-free diet', 'type': 'BEHAVIORAL', 'description': 'Polyamine-free diet in the 7 days befor surgery', 'armGroupLabels': ['R+ / K+', 'R+ / K-']}, {'name': 'Ketamine or placebo', 'type': 'DRUG', 'description': 'Peroperative and post operative (48h) ketamine injection', 'armGroupLabels': ['R+ / K+', 'R+ / K-', 'R- / K+', 'R- /K-']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': "CLCC-Institut Bergonie, service d'anesthésie réanimation, 229 cours de l'Argonne", 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': "département d'anesthésie-réanimation 3, hôpital Pellegrin", 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '54511', 'city': 'Nancy', 'country': 'France', 'facility': 'CLCC Alexis Vautrin', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': "APHParis Hôpital Pitié Salpétrière - Dépt. d'anesthésie réanimation", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'CLCC Réné Huguenin de Saint Cloud', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}], 'overallOfficials': [{'name': 'Pierre MAURETTE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DAR 3 -Pellegrin hospital-33076 Bordeaux - France'}, {'name': 'Genevieve CHENE, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'University hospital - 33076 Bordeaux - France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}, {'name': 'Insurance CNP foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Jean-Pierre LEROY / Clinical Research and Innovation Director', 'oldOrganization': 'University Hospital, Bordeaux'}}}}