Neuropathic Pain Induced by Mastectomy
Conditions
Keywords
Breast cancer, Mastectomy, Pain, Anxiety and Depression, Cognition, Quality of life
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.
Interventions
DRUGMagnesium: 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
DRUGPlacebo: 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
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 ...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Plasma and erythrocyte assays of magnesium | at inclusion visit, month 1 and month 3 |
| Creatinine dosage | at inclusion visit |
| Urine assays of magnesium | at month 1 and month 3 |
| Anxiety and Depression assessment by DASS scale | at month 1 and month 3 |
Countries
France
Contacts
Primary ContactPatrick LACARIN
Outcome results
None listed