NCT03063931

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

February 21, 2017

Last Update Submit

February 24, 2017

Conditions

Neuropathic Pain Induced by Mastectomy

Keywords

Breast cancerMastectomyPainAnxiety and DepressionCognitionQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

magnesium

EXPERIMENTAL
Drug: Magnesium: Magnésium UPSA Action Continue®

placebo

PLACEBO COMPARATOR
Drug: Placebo: Lactose

Interventions

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

magnesium
Placebo: LactoseDRUG

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Age ≥ 18 years,
  • 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

You may not qualify if:

  • 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
  • Patients undergoing a measure of legal protection (guardianship, supervision ...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 30287600DERIVED

MeSH Terms

Conditions

Breast NeoplasmsPainAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Gisèle PICKERING

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2017

First Posted

February 24, 2017

Study Start

March 1, 2017

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

FR(1)