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Polyamine-free Diet to Prevent Post Surgery Hyperalgesia

NCT ID: NCT00304850

Last Updated: 2009-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-05-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Breast Cancer Surgery

Keywords

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polyamines pain breast cancer mastectomy post operative pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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R+ / K+

Group Type EXPERIMENTAL

polyamine-free diet

Intervention Type BEHAVIORAL

Polyamine-free diet in the 7 days befor surgery

Ketamine or placebo

Intervention Type DRUG

Peroperative and post operative (48h) ketamine injection

R+ / K-

Group Type EXPERIMENTAL

polyamine-free diet

Intervention Type BEHAVIORAL

Polyamine-free diet in the 7 days befor surgery

Ketamine or placebo

Intervention Type DRUG

Peroperative and post operative (48h) ketamine injection

R- / K+

Group Type EXPERIMENTAL

Ketamine or placebo

Intervention Type DRUG

Peroperative and post operative (48h) ketamine injection

R- /K-

Group Type PLACEBO_COMPARATOR

Ketamine or placebo

Intervention Type DRUG

Peroperative and post operative (48h) ketamine injection

Interventions

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polyamine-free diet

Polyamine-free diet in the 7 days befor surgery

Intervention Type BEHAVIORAL

Ketamine or placebo

Peroperative and post operative (48h) ketamine injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Insurance CNP foundation

UNKNOWN

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Bordeaux

Principal Investigators

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Pierre MAURETTE, Pr

Role: PRINCIPAL_INVESTIGATOR

DAR 3 -Pellegrin hospital-33076 Bordeaux - France

Genevieve CHENE, Pr

Role: STUDY_CHAIR

University hospital - 33076 Bordeaux - France

Locations

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CLCC-Institut Bergonie, service d'anesthésie réanimation, 229 cours de l'Argonne

Bordeaux, , France

Site Status

département d'anesthésie-réanimation 3, hôpital Pellegrin

Bordeaux, , France

Site Status

CLCC Alexis Vautrin

Nancy, , France

Site Status

APHParis Hôpital Pitié Salpétrière - Dépt. d'anesthésie réanimation

Paris, , France

Site Status

CLCC Réné Huguenin de Saint Cloud

Saint-Cloud, , France

Site Status

Countries

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France

Other Identifiers

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2002-004

Identifier Type: -

Identifier Source: secondary_id

9258-03

Identifier Type: -

Identifier Source: org_study_id