Clinical trial NCT03063931: Pain and Magnesium
Official title: Effect of the Oral Route of Magnesium on Pre and Post-mastectomy on the Post-surgery Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neuropathic Pain Induced by Mastectomy
Keywords: Breast cancer
Mastectomy
Pain
Anxiety and Depression
Cognition
Quality of life
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 ...)

Primary outcomes:
measure: Measure of average pain intensity by a numerical rating scale
timeFrame: 5 days before the visit at 1 month post-mastectomy
Secondary outcomes:
measure: Pain assessment by the Neuropathic pain questionnaire
timeFrame: at month 1 and Month 3
measure: Evaluation of analgesic consumption
timeFrame: at 3 month
measure: Cognitive assessment by Trail Making Test A and B
timeFrame: at month 1 and month 3
measure: Quality of life assessment by EORTC QLQ-C30
timeFrame: at month 1 and month 3
measure: Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)
timeFrame: at month 1 and month 3
measure: Anxiety and Depression assessment by DASS scale
timeFrame: at month 1 and month 3
measure: Plasma and erythrocyte assays of magnesium
timeFrame: at inclusion visit, month 1 and month 3
measure: Creatinine dosage
timeFrame: at inclusion visit
measure: Urine assays of magnesium
timeFrame: at month 1 and month 3
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle PICKERING
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morel V, Joly D, Villatte C, Pereira B, Pickering G. Preventive effect of oral magnesium in postmastectomy pain: protocol for a randomised, double-blind, controlled clinical trial. BMJ Open. 2018 Oct 4;8(9):e017986. doi: 10.1136/bmjopen-2017-017986.