Neuropathic Pain Induced by Mastectomy Clinical Trial
Official title:
Effect of the Oral Route of Magnesium on Pre and Post-mastectomy on the Post-surgery Pain
In breast cancer patients undergoing a mastectomy, the aim of this study is to evaluate if the magnesium administered for 6 weeks starting two weeks before the surgery induces a decrease of pain intensity one month post-mastectomy compared to the placebo group.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | April 2019 |
| Est. primary completion date | March 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - - Age = 18 years, - Patient with breast cancer who has a scheduled total mastectomy with or without treatment two weeks after inclusion with or without preoperative chemotherapy, - Patient free from any new treatment or diet at the time of the inclusion, - Cooperation and understanding sufficient to comply with the requirements of the study, - Patients affiliated to the French Social Security, - Patients with free and informed consent has been obtained Exclusion Criteria: - Hypersensitivity to the active substance or to any of the excipients - Patient with magnesemia >1,05 mmol/l - Patient with severe renal insufficiency with creatinine clearance <30 ml min, - Patient with an addiction to alcohol, as determined by the investigator, - Diabetes (type I and II), - Medical and surgical history incompatible with the study, - Patient receiving treatment with Quinidine, L-Dopa, - Childbearing age, no use of effective contraceptive method, pregnancy or lactation - Patient exclusion period, or the total allowable compensation exceeded - Patients undergoing a measure of legal protection (guardianship, supervision ...) |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measure of average pain intensity by a numerical rating scale | Measure of average pain intensity by a numerical rating scale assessed 5 days before the visit at 1 month post-mastectomy in magnesium and placebo groups. | 5 days before the visit at 1 month post-mastectomy | |
| Secondary | Pain assessment by the Neuropathic pain questionnaire | at month 1 and Month 3 | ||
| Secondary | Evaluation of analgesic consumption | at 3 month | ||
| Secondary | Cognitive assessment by Trail Making Test A and B | at month 1 and month 3 | ||
| Secondary | Quality of life assessment by EORTC QLQ-C30 | at month 1 and month 3 | ||
| Secondary | Quality of life assessment by Pittsburg Sleep Quality Index (PSQI) | at month 1 and month 3 | ||
| Secondary | Anxiety and Depression assessment by DASS scale | at month 1 and month 3 | ||
| Secondary | Plasma and erythrocyte assays of magnesium | at inclusion visit, month 1 and month 3 | ||
| Secondary | Creatinine dosage | at inclusion visit | ||
| Secondary | Urine assays of magnesium | at month 1 and month 3 |