Pain and Magnesium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neuropathic Pain Induced by Mastectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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magnesium

Group Type EXPERIMENTAL

Magnesium: Magnésium UPSA Action Continue®

Intervention Type 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

placebo

Group Type PLACEBO_COMPARATOR

Placebo: Lactose

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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 ...)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No