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Pain and Magnesium

Primary Purpose

Neuropathic Pain Induced by Mastectomy

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Magnesium: Magnésium UPSA Action Continue®

Placebo: Lactose

About this trial

This is an interventional prevention trial for Neuropathic Pain Induced by Mastectomy focused on measuring Breast cancer, Mastectomy, Pain, Anxiety and Depression, Cognition, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 ...)

Sites / Locations

CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

magnesium

placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain assessment by the Neuropathic pain questionnaire

Evaluation of analgesic consumption

Cognitive assessment by Trail Making Test A and B

Quality of life assessment by EORTC QLQ-C30

Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)

Anxiety and Depression assessment by DASS scale

Plasma and erythrocyte assays of magnesium

Creatinine dosage

Urine assays of magnesium

Full Information

NCT ID

NCT03063931

First Posted

February 21, 2017

Last Updated

February 24, 2017

Sponsor

University Hospital, Clermont-Ferrand

1. Study Identification

Unique Protocol Identification Number

NCT03063931

Brief Title

Pain and Magnesium

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 2017 (Anticipated)

Primary Completion Date

March 2019 (Anticipated)

Study Completion Date

April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain Induced by Mastectomy

Keywords

Breast cancer, Mastectomy, Pain, Anxiety and Depression, Cognition, Quality of life

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

magnesium

Arm Type

Experimental

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Magnesium: Magnésium UPSA Action Continue®

Intervention Description

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

Intervention Name(s)

Placebo: Lactose

Intervention Description

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

Primary Outcome Measure Information:

Title

Measure of average pain intensity by a numerical rating scale

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.

Time Frame

5 days before the visit at 1 month post-mastectomy

Secondary Outcome Measure Information:

Title

Pain assessment by the Neuropathic pain questionnaire

Time Frame

at month 1 and Month 3

Title

Evaluation of analgesic consumption

Time Frame

at 3 month

Title

Cognitive assessment by Trail Making Test A and B

Time Frame

at month 1 and month 3

Title

Quality of life assessment by EORTC QLQ-C30

Time Frame

at month 1 and month 3

Title

Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)

Time Frame

at month 1 and month 3

Title

Anxiety and Depression assessment by DASS scale

Time Frame

at month 1 and month 3

Title

Plasma and erythrocyte assays of magnesium

Time Frame

at inclusion visit, month 1 and month 3

Title

Creatinine dosage

Time Frame

at inclusion visit

Title

Urine assays of magnesium

Time Frame

at month 1 and month 3

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 ...)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gisèle PICKERING

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

First Name & Middle Initial & Last Name & Degree

Dominique JOLY

First Name & Middle Initial & Last Name & Degree

Christine VILLATTE

First Name & Middle Initial & Last Name & Degree

Christophe POMEL

First Name & Middle Initial & Last Name & Degree

Pierre GIMBERGUES

First Name & Middle Initial & Last Name & Degree

Xavier DURANDO

First Name & Middle Initial & Last Name & Degree

Claude DUBRAY

12. IPD Sharing Statement

Citations:

PubMed Identifier

30287600

Citation

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.

Results Reference

derived

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Pain and Magnesium

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