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

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    ketamine ...
  • Study Participants

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
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 Started
Mar 31
Primary Completion
Apr 30
Study Completion
May 31
Last Update
Dec 29

Behavioral polyamine-free diet

Polyamine-free diet in the 7 days befor surgery

Drug Ketamine or placebo

Peroperative and post operative (48h) ketamine injection

R+ / K+ Experimental

R+ / K- Experimental

R- / K+ Experimental

R- /K- Placebo Comparator


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
No Results Posted