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Polyamine-Free Diet to Prevent Post Surgery Hyperalgesia (PoLyDOL)
This study is currently recruiting participants.
Verified by University Hospital, Bordeaux, June 2007
Sponsors and Collaborators: University Hospital, Bordeaux
Ministry of Health, France
Insurance CNP foundation
Information provided by: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00304850
  Purpose

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


Condition Intervention Phase
Breast Cancer
Surgery
Behavioral: polyamine-free diet
Drug: Ketamine
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Ketamine Ketamine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title: Efficacy of a Polyamine-Free Diet Associated or Not With Ketamine on Early and Late Hyperalgesia After Breast Cancer Surgery

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Morphine requirement [ Time Frame: for the 24 postoperative hours ]

Secondary Outcome Measures:
  • Pain intensity for the 4 days (and possibly at 7th day if the patient is still hospitalized) after surgery [ Time Frame: 4 days ]
  • Allodynia measurements
  • Hyperesthesia measurements
  • Chronic pain incidence
  • Late allodynia and/or hyperesthesia (6 months)
  • safety of treatment

Estimated Enrollment: 160
Study Start Date: March 2006
Estimated Study Completion Date: August 2008
Detailed Description:

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).

The 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.

Polyamines 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer (T1, T2, T3, N0, N1, M0)
  • Age : 18 – 75
  • Asa 1-3
  • left or right tumorectomy with complete lymphadenectomy
  • left or right complete mastectomy with complete lymphadenectomy
  • complete lymphadenectomy within one week following simple tumorectomy
  • informed consent signed

Exclusion Criteria:

  • inflammatory tumor requiring pre-operative radiotherapy
  • previous history of total mastectomy or partial contralateral mastectomy
  • chronic inflammatory disease treated by corticoids or NSAI
  • chronic analgesic treatment
  • anti-arrhythmic or anti-epileptic treatments
  • morphinic treatment during the 7 days before surgery
  • excessive alcohol consumption or addiction
  • ketamine or neomycin contra-indication
  • severe cardiovascular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304850

Contacts
Contact: Pierre MAURETTE, Pr 33(0)556795515 pierre.maurette@chu-bordeaux.fr

Locations
France
département d'anesthésie-réanimation 3, hôpital Pellegrin Recruiting
Bordeaux, France, 33076
Contact: Pierre MAURETTE, Pr     33(0)556795515     pierre.maurette@chu-bordeaux.fr    
Principal Investigator: Pierre MAURETTE, Pr            
Sub-Investigator: Alain ROCHE, Dr            
Sub-Investigator: Jean Marie GBOSSOU, Dr            
CLCC-Institut Bergonie, service d'anesthésie réanimation, 229 cours de l'Argonne Recruiting
Bordeaux, France, 33000
Contact: Fabrice LAKDJA, Dr     33(0)556333264        
Principal Investigator: Fabrice LAKDJA, Dr            
APHParis Hôpital Pitié Salpétrière - Dépt. d'anesthésie réanimation Recruiting
PARIS, France, 75013
Contact: Frédéric Aubrun, Dr     33 (0) 1 42 16 22 72        
Principal Investigator: Frédéric Aubrun, Dr            
CLCC Réné Huguenin de Saint Cloud Recruiting
Saint Cloud, France, 92210
Contact: Christian Jayr, Dr     33 (0) 1 47 11 15 15        
Principal Investigator: Christian Jayr            
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
Insurance CNP foundation
Investigators
Principal Investigator: Pierre MAURETTE, Pr DAR 3 -Pellegrin hospital-33076 Bordeaux - France
Study Chair: Genevieve CHENE, Pr University hospital - 33076 Bordeaux - France
  More Information

Study ID Numbers: 9258-03, 2002-004
Study First Received: March 17, 2006
Last Updated: June 12, 2007
ClinicalTrials.gov Identifier: NCT00304850  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:
polyamines
pain
breast cancer
mastectomy
post operative pain

Study placed in the following topic categories:
Excitatory Amino Acids
Signs and Symptoms
Sensation Disorders
Somatosensory Disorders
Skin Diseases
Ketamine
Neurologic Manifestations
Breast Neoplasms
Pain
Hyperalgesia
Breast Diseases
Pain, Postoperative

Additional relevant MeSH terms:
Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Anesthetics, Dissociative
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009