Pain and Magnesium

Effect of the Oral Route of Magnesium on Pre and Post-mastectomy on the Post-surgery Pain

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.

Study Overview

• Status: Unknown
• Conditions: Neuropathic Pain Induced by Mastectomy
• Intervention / Treatment: Drug: Magnesium: Magnésium UPSA Action Continue®; Drug: Placebo: Lactose

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand
    • Sub-Investigator: Claude DUBRAY
    • Sub-Investigator: Dominique JOLY
    • Sub-Investigator: Christine VILLATTE
    • Sub-Investigator: Xavier DURANDO
    • Sub-Investigator: Christophe POMEL
    • Sub-Investigator: Pierre GIMBERGUES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 ...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo: 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
Experimental: magnesium	Drug: Magnesium: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 24, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Pain; Quality of life; Breast cancer; Cognition; Mastectomy; Anxiety and Depression
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: CHU-306; 2016-A01749-42 (Other Identifier: 2016-A01749-42)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No