Pain and Magnesium

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a randomized, placebo-controlled double-blind clinical trial conducted in the Oncology Hospital, Clermont-Ferrand, France, in 100 patients suffering from breast cancer and undergoing a total mastectomy. This clinical trial compares magnesium and placebo for the prevention of neuropathic pain induced by mastectomy assessed with a (0-10) numerical pain rating scale. Cognition, anxiety, depression, sleep and quality of life are also assessed.

Official Title
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Effect of the Oral Route of Magnesium on Pre and Post-mastectomy on the Post-surgery Pain

Conditions
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Neuropathic Pain Induced by Mastectomy

Intervention / Treatment
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* Drug: Magnesium: Magnésium UPSA Action Continue®
* Drug: Placebo: Lactose


Participation Criteria
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Eligibility Criteria
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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 ...)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: magnesium<br> | Drug: Magnesium: Magnésium UPSA Action Continue®<br>* This clinical trial compares magnesium and placebo for the prevention of neuropathic pain induced by mastectomy assessed with a (0-10) numerical pain rating scale<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo: Lactose<br>* This clinical trial compares magnesium and placebo for the prevention of neuropathic pain induced by mastectomy assessed with a (0-10) numerical pain rating scale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment by the Neuropathic pain questionnaire |  | at month 1 and Month 3 | 
| Evaluation of analgesic consumption |  | at 3 month | 
| Cognitive assessment by Trail Making Test A and B |  | at month 1 and month 3 | 
| Quality of life assessment by EORTC QLQ-C30 |  | at month 1 and month 3 | 
| Quality of life assessment by Pittsburg Sleep Quality Index (PSQI) |  | at month 1 and month 3 | 
| Anxiety and Depression assessment by DASS scale |  | at month 1 and month 3 | 
| Plasma and erythrocyte assays of magnesium |  | at inclusion visit, month 1 and month 3 | 
| Creatinine dosage |  | at inclusion visit | 
| Urine assays of magnesium |  | at month 1 and month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Mastectomy, Pain, Anxiety and Depression, Cognition, Quality of life