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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01749-42 | Other Identifier | 2016-A01749-42 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| magnesium | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium: Magnésium UPSA Action Continue® | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of average pain intensity by a numerical rating scale | 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. | 5 days before the visit at 1 month post-mastectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment by the Neuropathic pain questionnaire | at month 1 and Month 3 | |
| Evaluation of analgesic consumption | at 3 month | |
| Cognitive assessment by Trail Making Test A and B |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Gisèle PICKERING | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30287600 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Placebo: Lactose | Drug | 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 |
|
| 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 |
| Anxiety and Depression assessment by DASS scale | 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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |