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| Name | Class |
|---|---|
| Grünenthal GmbH | INDUSTRY |
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Breast cancer is the most common cancer in women in Europe. Therefore, breast cancer has become a chronic disease and patients need to learn to live with it as well as with the adverse effects related to the disease itself or to the therapies used.
As noted in the third "Plan cancer", pain is a major criterion in the quality of life of patients treated for breast cancer.
Neuropathic pain was defined in 2011 by the international Association for the Study of Pain (I.A.S.P.) as the direct result of a lesion or disease affecting the somato-sensory system.
Surgical treatment is often the first treatment of breast cancer. It can be conservative by performing a partial mastectomy (lumpectomy or quadrantectomy) or non-preservative by total mastectomy.
Intercostobrachial neuralgia (NICB) or Post mastectomy painful Syndrome (MPRR) was first described by Wood in 1978 as "chronic pain beginning immediately or early after a mastectomy" Or a lumpectomy affecting the anterior thorax, armpit and/or arm in its upper half. These post-surgical pains are related to a lesion of the nerves in the breast area.
In particular, the intercostobrachial nerve can be severed, stretched or crushed during surgery.
Post-operative neuropathic pain in patients with breast cancer is underdiagnosed either by general practitioner or in a specialized environment.
The diagnosis of neuropathic pain is performed during examination and clinical examination. Several scales allow to detect neuropathic pain but only the DN4 is recognized to be the most specific and sensitive scale.
Patients do not always express this pain. They do not always reconcile with the surgery. Either because the pain occurs a long time after the surgery, or they find it normal to get hurt. These diagnostic difficulties cause a delay in setting up a suitable analgesic treatment.
However, neuropathic pain responds poorly to common analgesics. Diagnosis, evaluation and early management of neuropathic pain are a priority in order to avoid their chronicization, to improve the quality of life of patients with breast cancer and to enable them to return to work quickly.
We therefore assume that the diagnosis of early neuropathic pain at 2 months of surgery associated with initiation of appropriate topical treatment without the systemic effects of conventional oral treatments, would reduce the incidence of Chronic neuropathic pain 6 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm CAPSAICINE topical | Experimental | Application of capsaicin patches at 8% on the painful area 1 to 2 patches will be administered during the consultation. If necessary, a second application will be realized 3 months later. |
|
| Arm PREGABALINE | Active Comparator | Pregabalin tablets will be initiated at a dose of 50 mg / day taken in 2 doses Depending on the tolerance, the dose will be increased to 100 mg / day and then to 150 mg / day to reach a maximum dose of 600 mg / day. An interval of 3 to 7 days must be observed between each dose increase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin | Drug | Application of capsaicin patches at 8% on painful area |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neuropathic Pain Score at 2 Months (Numeric Rating Scale 0-10) | Pain intensity was assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where:
| 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 6 Months in Neuropathic Pain Score (Numeric Rating Scale 0-10) | Neuropathic pain intensity was assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The outcome measure represents the change in NRS score from baseline to 6 months, calculated as the score at 6 months minus the score at baseline. Negative values indicate an improvement in pain, and positive values indicate worsening of pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DENIS DUPOIRON, MD | Institut de Cancérologie de l'Ouest | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de L'Ouest | Angers | 49000 | France | |||
| Chu Grenoble |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm CAPSAICINE Topical | Application of capsaicin patches at 8% on the painful area 1 to 2 patches will be administered during the consultation. If necessary, a second application will be realized 3 months later. Capsaicin: Application of capsaicin patches at 8% on painful area |
| FG001 | Arm PREGABALINE | Pregabalin tablets will be initiated at a dose of 50 mg / day taken in 2 doses Depending on the tolerance, the dose will be increased to 100 mg / day and then to 150 mg / day to reach a maximum dose of 600 mg / day. An interval of 3 to 7 days must be observed between each dose increase. Pregabalin: Taking Pregabalin tablets |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm CAPSAICINE Topical | Application of capsaicin patches at 8% on the painful area 1 to 2 patches will be administered during the consultation. If necessary, a second application will be realized 3 months later. Capsaicin: Application of capsaicin patches at 8% on painful area |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Neuropathic Pain Score at 2 Months (Numeric Rating Scale 0-10) | Pain intensity was assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where:
| Posted | Mean | Standard Deviation | units on a scale | 2 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm CAPSAICINE Topical | Application of capsaicin patches at 8% on the painful area 1 to 2 patches will be administered during the consultation. If necessary, a second application will be realized 3 months later. Capsaicin: Application of capsaicin patches at 8% on painful area |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site burning | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr DENIS DUPOIRON | INSTITUT DE CANCEROLOGIE DE L'OUEST | 02 41 35 27 00 | +33 | Denis.Dupoiron@ico.unicancer.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2021 | Apr 21, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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Multicenter, open, randomized study
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| Pregabalin | Drug | Taking Pregabalin tablets |
|
|
| 6 months |
| Grenoble |
| 38700 |
| France |
| Chd Vendee | La Roche-sur-Yon | 85025 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Hopital Saint Vincent de Paul | Lille | 59020 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| CHU NICE | Nice | 06003 | France |
| Institut Jean Godinot | Reims | 51100 | France |
| Institut Curie | Saint-Cloud | 92210 | France |
| Iuct Oncopole | Toulouse | 31052 | France |
| Ch Valenciennes | Valenciennes | 53322 | France |
| Arm PREGABALINE |
Pregabalin tablets will be initiated at a dose of 50 mg / day taken in 2 doses Depending on the tolerance, the dose will be increased to 100 mg / day and then to 150 mg / day to reach a maximum dose of 600 mg / day. An interval of 3 to 7 days must be observed between each dose increase. Pregabalin: Taking Pregabalin tablets |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
Pregabalin tablets will be initiated at a dose of 50 mg / day taken in 2 doses Depending on the tolerance, the dose will be increased to 100 mg / day and then to 150 mg / day to reach a maximum dose of 600 mg / day.
An interval of 3 to 7 days must be observed between each dose increase.
Pregabalin: Taking Pregabalin tablets
|
|
| Secondary | Change From Baseline to 6 Months in Neuropathic Pain Score (Numeric Rating Scale 0-10) | Neuropathic pain intensity was assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The outcome measure represents the change in NRS score from baseline to 6 months, calculated as the score at 6 months minus the score at baseline. Negative values indicate an improvement in pain, and positive values indicate worsening of pain. | Posted | Mean | Standard Deviation | units | 6 months |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 8 |
| 65 |
| EG001 | Arm PREGABALINE | Pregabalin tablets will be initiated at a dose of 50 mg / day taken in 2 doses Depending on the tolerance, the dose will be increased to 100 mg / day and then to 150 mg / day to reach a maximum dose of 600 mg / day. An interval of 3 to 7 days must be observed between each dose increase. Pregabalin: Taking Pregabalin tablets | 0 | 51 | 0 | 51 | 29 | 51 |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Confusion | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |