Polyamine-free Diet to Prevent Post Surgery Hyperalgesia
Brief Summary
Condition or Disease
- Breast Cancer
- Surgery
Phase
Study Design
Study type: | Interventional |
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Status: | Completed |
Study results: | No Results Available |
Age: | 18 Years to 75 Years (Adult, Older Adult) |
Enrollment: | 160 () |
Funded by: | Other |
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Clinical Trial Dates
Start date: | Mar 06, 2020 | |
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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
Location
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 |
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Minimum Age: | 18 |
Maximum Age: | 75 |
More Details
NCT Number: | NCT00304850 |
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Acronym: | PoLyDOL |
Other IDs: | 9258-03|2002-004 |
Study URL: | https://ClinicalTrials.gov/show/NCT00304850 |