Pain and Magnesium

Phase 2

• Conditions: Neuropathic Pain Induced by Mastectomy

• Registration Number: NCT03063931
• Lead Sponsor: University Hospital, Clermont-Ferrand

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 Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-27
• Study Start: 2017-03
• Primary Completion: 2019-03
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 ...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measure of average pain intensity by a numerical rating scale	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 Outcome Measures

Name	Time	Method
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
Evaluation of analgesic consumption	at 3 month
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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France