Pain and Magnesium

University Hospital, Clermont-Ferrand

Status and phase

Unknown

Phase 2

Conditions

Neuropathic Pain Induced by Mastectomy

Treatments

Drug: Magnesium: Magnésium UPSA Action Continue®

Drug: Placebo: Lactose

Study type

Interventional

Funder types

Other

Identifiers

NCT03063931

2016-A01749-42 (Other Identifier)

CHU-306

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 ...)