Clinical trial · Interventional
Pain and Magnesium
Effect of the Oral Route of Magnesium on Pre and Post-mastectomy on the Post-surgery Pain
NCT03063931CI-TRIAL-00026175unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuropathic Pain Induced by Mastectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnesium: Magnésium UPSA Action Continue® | Drug | — | UNRESOLVED |
| Placebo: Lactose | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- magnesium
- interventionNames
- Drug: Magnesium: Magnésium UPSA Action Continue®
- type
- PLACEBO_COMPARATOR
- label
- placebo
- interventionNames
- Drug: Placebo: Lactose
Primary outcomes (1)
- measure
- Measure of average pain intensity by a numerical rating scale
- timeFrame
- 5 days before the visit at 1 month post-mastectomy
- description
- 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 outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 ...)
References
Publications (1)
- DERIVEDMorel 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. PMID 30287600