Effect of the Oral Route of Magnesium on Pre and Post-mastectomy on the Post-surgery Pain
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Measure of average pain intensity by a numerical rating scale
Study Overview
Brief 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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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 ...)
Arms & Interventions
magnesium
Intervention: Magnesium: Magnésium UPSA Action Continue® (Drug)
placebo
Intervention: Placebo: Lactose (Drug)
Outcomes
Primary Outcomes
Measure of average pain intensity by a numerical rating scale
Time Frame: 5 days before the visit at 1 month post-mastectomy
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.
Secondary Outcomes
- 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)
- Pain assessment by the Neuropathic pain questionnaire(at month 1 and Month 3)
- Anxiety and Depression assessment by DASS scale(at month 1 and month 3)
- Urine assays of magnesium(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)