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

Phase 2
18 Years
75 Years
Not Enrolling
Breast Cancer, Surgery

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Morphine requirement

Outcome Time Frame:

for the 24 postoperative hours

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

DAR 3 -Pellegrin hospital-33076 Bordeaux - France


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

March 2006

Completion Date:

May 2009

Related Keywords:

  • Breast Cancer
  • Surgery
  • polyamines
  • pain
  • breast cancer
  • mastectomy
  • post operative pain
  • Breast Neoplasms
  • Hyperalgesia