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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
100
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
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
CHU Clermont-Ferrand
Clermont-Ferrand, France
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.
Time frame: 5 days before the visit at 1 month post-mastectomy
Pain assessment by the Neuropathic pain questionnaire
Time frame: at month 1 and Month 3
Evaluation of analgesic consumption
Time frame: at 3 month
Cognitive assessment by Trail Making Test A and B
Time frame: at month 1 and month 3
Quality of life assessment by EORTC QLQ-C30
Time frame: at month 1 and month 3
Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)
Time frame: at month 1 and month 3
Anxiety and Depression assessment by DASS scale
Time frame: at month 1 and month 3
Plasma and erythrocyte assays of magnesium
Time frame: at inclusion visit, month 1 and month 3
Creatinine dosage
Time frame: at inclusion visit
Urine assays of magnesium
Time frame: at month 1 and month 3
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