Neuropathic Pain Induced by MastectomyPhase 2NCT03063931
Pain and Magnesium
A Phase 2 study testing Magnesium: Magnésium UPSA Action Continue® in people with Neuropathic Pain Induced by Mastectomy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neuropathic Pain Induced by Mastectomy
- What is being tested?
- Magnesium: Magnésium UPSA Action Continue®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2017to Apr 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- 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,
Show all 10Show fewer
- 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 ...)
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Dominique JOLY
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuropathic Pain Induced by Mastectomy
- Being tested
- Magnesium: Magnésium UPSA Action Continue®, Placebo: Lactose
- Keywords
- Breast cancer, Mastectomy, Pain, Anxiety and Depression, Cognition, Quality of life
- Medical subject headings
- Breast Neoplasms, Pain, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| magnesium | Experimental | Not described Receives: Drug: Magnesium: Magnésium UPSA Action Continue® |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo: Lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days before the visit at 1 month post-mastectomy
Secondary outcomes (9)
Pain assessment by the Neuropathic pain questionnaire
Measured: at month 1 and Month 3
Evaluation of analgesic consumption
Measured: at 3 month
Cognitive assessment by Trail Making Test A and B
Measured: at month 1 and month 3
Quality of life assessment by EORTC QLQ-C30
Measured: at month 1 and month 3
Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)
Measured: at month 1 and month 3
Anxiety and Depression assessment by DASS scale
Measured: at month 1 and month 3
Plasma and erythrocyte assays of magnesium
Measured: at inclusion visit, month 1 and month 3
Creatinine dosage
Measured: at inclusion visit
Urine assays of magnesium
Measured: at month 1 and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study startMar 2017 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic Pain Induced by MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063931
- Sponsor's protocol ID
- CHU-306
- Other IDs
- 2016-A01749-42
- Status last verified
- Feb 2017
- First submitted
- 21 Feb 2017
- Last updated
- 27 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30287600
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Oral Route of Magnesium on Pre and Post-mastectomy on the Post-surgery Pain
- ClinicalTrials.gov ID
- NCT03063931
- Acronym / sponsor ID
- CHU-306
- Conditions
- Neuropathic Pain Induced by Mastectomy
- Keywords
- Breast cancer, Mastectomy, Pain, Anxiety and Depression, Cognition, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnesium | Experimental | Drug: Magnesium: Magnésium UPSA Action Continue® |
| placebo | Placebo comparator | Drug: Placebo: Lactose |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - 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,
Key exclusion criteria (10 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | magnesium |
| Placebo: LactoseThis clinical trial compares magnesium and placebo for the prevention of neuropathic pain induced by mastectomy assessed with a (0-10) numerical pain rating scale | Drug | placebo |
Primary outcome
Measure of average pain intensity by a numerical rating scale
Time frame: 5 days before the visit at 1 month post-mastectomy
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.
9 secondary outcomes
Pain assessment by the Neuropathic pain questionnaire
Time frame: at month 1 and Month 3
Evaluation of analgesic consumption
Time frame: at 3 month
Cognitive assessment by Trail Making Test A and B
Time frame: at month 1 and month 3
Quality of life assessment by EORTC QLQ-C30
Time frame: at month 1 and month 3
Quality of life assessment by Pittsburg Sleep Quality Index (PSQI)
Time frame: at month 1 and month 3
Anxiety and Depression assessment by DASS scale
Time frame: at month 1 and month 3
Plasma and erythrocyte assays of magnesium
Time frame: at inclusion visit, month 1 and month 3
Creatinine dosage
Time frame: at inclusion visit
Urine assays of magnesium
Time frame: at month 1 and month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Derived from this study: PubMed 30287600Morel 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisèle PICKERING principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium: Magnésium UPSA Action Continue® in people with Neuropathic Pain Induced by Mastectomy, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of average pain intensity by a numerical rating scale (time frame: 5 days before the visit at 1 month post-mastectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03063931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.