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NCT Number: NCT00304850

Polyamine-free Diet to Prevent Post Surgery Hyperalgesia

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Surgery

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

polyamine-free diet

Behavioral

Polyamine-free diet in the 7 days befor surgery

Ketamine or placebo

Drug

Peroperative and post operative (48h) ketamine injection

Primary outcomes

  1. Morphine requirement

    Time frame: for the 24 postoperative hours

Secondary outcomes

  1. Pain intensity for the 4 days (and possibly at 7th day if the patient is still hospitalized) after surgery

    Time frame: 4 days

  2. Allodynia measurements

    Time frame: inclusion, 1, 2, 4 and 7 ddays after surgery

  3. Hyperesthesia measurements

    Time frame: inclusion, 1, 2, 4 and 7 ddays after surgery

  4. Chronic pain incidence

    Time frame: 3 and 6 months

  5. Late allodynia and/or hyperesthesia

    Time frame: 6 months

  6. safety of treatment

    Time frame: Along each patient folow-up

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Insurance CNP foundation
  • Ministry of Health, France

Registry information

Official study title

Efficacy of a Polyamine-free Diet Associated or Not With Ketamine on Early and Late Hyperalgesia After Breast Cancer Surgery

Acronym: PoLyDOL

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Mar 20, 2006
Registry last updated
Dec 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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