Polyamine-free Diet to Prevent Post Surgery Hyperalgesia

Brief Summary

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

Intervention / Treatment

  • Behavioral: polyamine-free diet
  • Drug: Ketamine or placebo

Condition or Disease

  • Breast Cancer
  • Surgery

Phase

Study Design

Study type: Interventional
Status: Completed
Study results: No Results Available
Age: 18 Years to 75 Years   (Adult, Older Adult)
Enrollment: 160 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Mar 06, 2020
Primary Completion: Apr 09, 2020
Completion Date: May 09, 2020
Study First Posted: Mar 20, 2006
Results First Posted: Aug 31, 2020
Last Updated: Dec 29, 2009

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: Female
Minimum Age: 18
Maximum Age: 75

More Details

NCT Number: NCT00304850
Acronym: PoLyDOL
Other IDs: 9258-03|2002-004
Study URL: https://ClinicalTrials.gov/show/NCT00304850
Last updated: Jan 28, 2021