Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketamine or placebo | Drug | — | UNRESOLVED |
| polyamine-free diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- R+ / K+
- interventionNames
- Behavioral: polyamine-free diet
- Drug: Ketamine or placebo
- type
- EXPERIMENTAL
- label
- R+ / K-
- interventionNames
- Behavioral: polyamine-free diet
- Drug: Ketamine or placebo
- type
- EXPERIMENTAL
- label
- R- / K+
- interventionNames
- Drug: Ketamine or placebo
- type
- PLACEBO_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available