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Sponsors and Collaborators: |
University Hospital, Bordeaux Ministry of Health, France Insurance CNP foundation |
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Information provided by: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00304850 |
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 |
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Breast Cancer Surgery |
Behavioral: polyamine-free diet Drug: Ketamine |
Phase II |
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 |
Estimated Enrollment: | 160 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | August 2008 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pierre MAURETTE, Pr | 33(0)556795515 | pierre.maurette@chu-bordeaux.fr |
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 |
Principal Investigator: | Pierre MAURETTE, Pr | DAR 3 -Pellegrin hospital-33076 Bordeaux - France |
Study Chair: | Genevieve CHENE, Pr | University hospital - 33076 Bordeaux - France |
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 |
polyamines pain breast cancer mastectomy post operative pain |
Excitatory Amino Acids Signs and Symptoms Sensation Disorders Somatosensory Disorders Skin Diseases Ketamine |
Neurologic Manifestations Breast Neoplasms Pain Hyperalgesia Breast Diseases Pain, Postoperative |
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 |