Pain and Magnesium (NCT03063931) | Clinical Trial Compass
UnknownPhase 2
Pain and Magnesium
France100 participantsStarted 2017-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- Age ā„ 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 ...)
What they're measuring
1
Measure of average pain intensity by a numerical rating scale
Timeframe: 5 days before the visit at 1 month post-mastectomy