NCT03063931

Pain and Magnesium

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuropathic Pain Induced by Mastectomy

Interventions

Type	Name	Description
DRUG	Magnesium: Magnésium UPSA Action Continue®	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
DRUG	Placebo: Lactose	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

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-03-01
• Completion: 2019-04-01
• First posted: 2017-02-24
• Last updated: 2017-02-27

Locations

1 site across 1 country: France