- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00304850
Polyamine-free Diet to Prevent Post Surgery Hyperalgesia (PoLyDOL)
Efficacy of a Polyamine-free Diet Associated or Not With Ketamine on Early and Late Hyperalgesia After Breast Cancer Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33000
- CLCC-Institut Bergonie, service d'anesthésie réanimation, 229 cours de l'Argonne
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Bordeaux, France, 33076
- département d'anesthésie-réanimation 3, hôpital Pellegrin
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Nancy, France, 54511
- CLCC Alexis Vautrin
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Paris, France, 75013
- APHParis Hôpital Pitié Salpétrière - Dépt. d'anesthésie réanimation
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Saint Cloud, France, 92210
- CLCC Réné Huguenin de Saint Cloud
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: R+ / K+
|
Polyamine-free diet in the 7 days befor surgery
Peroperative and post operative (48h) ketamine injection
|
Experimental: R+ / K-
|
Polyamine-free diet in the 7 days befor surgery
Peroperative and post operative (48h) ketamine injection
|
Experimental: R- / K+
|
Peroperative and post operative (48h) ketamine injection
|
Placebo Comparator: R- /K-
|
Peroperative and post operative (48h) ketamine injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Morphine requirement
Time Frame: for the 24 postoperative hours
|
for the 24 postoperative hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain intensity for the 4 days (and possibly at 7th day if the patient is still hospitalized) after surgery
Time Frame: 4 days
|
4 days
|
Allodynia measurements
Time Frame: inclusion, 1, 2, 4 and 7 ddays after surgery
|
inclusion, 1, 2, 4 and 7 ddays after surgery
|
Hyperesthesia measurements
Time Frame: inclusion, 1, 2, 4 and 7 ddays after surgery
|
inclusion, 1, 2, 4 and 7 ddays after surgery
|
Chronic pain incidence
Time Frame: 3 and 6 months
|
3 and 6 months
|
Late allodynia and/or hyperesthesia
Time Frame: 6 months
|
6 months
|
safety of treatment
Time Frame: Along each patient folow-up
|
Along each patient folow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre MAURETTE, Pr, DAR 3 -Pellegrin hospital-33076 Bordeaux - France
- Study Chair: Genevieve CHENE, Pr, University hospital - 33076 Bordeaux - France
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Neurologic Manifestations
- Breast Diseases
- Sensation Disorders
- Somatosensory Disorders
- Breast Neoplasms
- Hyperalgesia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- 9258-03
- 2002-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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