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Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery (CAPTRANE)

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ClinicalTrials.gov Identifier: NCT03794388
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Patient Drug: Capsaicin Drug: Pregabalin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 772 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, open, randomized study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Multicentric, Open, Randomized Study Comparing Topical Treatment by Patch of Capsaicin to 8% (Qutenza) to Pregabalin Oral in the Early Treatment of Neuropathic Pain After Primary Surgery for Breast Cancer
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : March 19, 2022
Estimated Study Completion Date : March 19, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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.

Drug: Capsaicin
Application of capsaicin patches at 8% on painful area
Other Name: qutenza EU/1/09/524/001

Active Comparator: 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.

Drug: Pregabalin
Taking Pregabalin tablets
Other Name: Lyrica




Primary Outcome Measures :
  1. To show the noninferiority of early early medical treatment by topical treatment with capsaicin compared to oral treatment of pregabalin on the evolution of neuropathic pain after 2 months in patients who have undergone surgical excision of breast cancer [ Time Frame: 2 months ]
    The 11-point numerical scale (0-10) is collected at 2 months.


Secondary Outcome Measures :
  1. To compare the efficacy of an early medical treatment with capsaicin topical treatment compared to oral treatment pregabalin on the evolution of neuropathic pain in patients who had undergone excision surgical breast cancer after 6 months of treatment [ Time Frame: 6 months ]
    The 11-point numerical scale of pain is also collected at the end of treatment

  2. To compare the functional change and quality of life perceived by patients after 2 and 6 months of treatment between the two arms: Questionnaire PGIC (patients' global impression of change) [ Time Frame: 6 months ]
    Questionnaire PGIC is administered to M4, M6 and at the end of treatment to measure the functional changes and quality of life changes experienced by the patient in the 2 treatment arms.

  3. To compare the functional change and quality of life perceived by patients after 2 and 6 months of treatment between the two arms [ Time Frame: 6 months ]
    Questionnaire QLQ-C30 (quality of life questionnaire) is administered to M4, M6 and at the end of treatment to measure the functional changes and quality of life changes experienced by the patient in the 2 treatment arms.

  4. To compare the functional change and quality of life perceived by patients after 2 and 6 months of treatment between the two arms [ Time Frame: 6 months ]
    Questionnaire EQ-5D is administered to M4, M6 and at the end of treatment to measure the functional changes and quality of life changes experienced by the patient in the 2 treatment arms.

  5. Regression of the painful area after 2 and 6 months of treatment between the two arms. [ Time Frame: 6 months ]
    The painful area is measured from pain mapping at baseline, and after 2 months and 6 months of treatment. It is measured by the area delimited by the contours of the painful surface (centralized reading).

  6. Tolerance of each type of treatment by collecting side effects in each treatment arm. [ Time Frame: 6 months ]
    The tolerance of the treatments will be measured by the number of patients having at least one adverse event of grade ≥ 2 according to the classification CTCAE v5.0.

  7. Proportion of patients for whom only 1 application has been sufficient. [ Time Frame: 6 months ]
    In the capsaicin arm, the number of total patches received by the patient during the 6 months will also be counted

  8. Impact of peri-surgical anxiety and depression on the development of neuropathic pain after surgery for breast cancer [ Time Frame: 49 months ]
    The HAD (Hospital anxiety and despression scale) questionnaire will be collected during the screening visit

  9. The incidence of NICBs 4 months after surgery for breast cancer [ Time Frame: 4 months ]
    The incidence of NICBs will be measured by the number of patients included in the study (DN4 +) compared to the number of patients screened before surgery

  10. The evolution of the weight between the two arms after 6 months of treatment. [ Time Frame: 6 months ]
    The weight is collected after 6 months of treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female who had first breast cancer surgery, regardless of the type of surgery
  • Age ≥ 18 years
  • Healthy, non-irritated skin on painful areas to treat
  • During the inclusion visit to M4 post surgery, neuropathic pain of the breast and / or axillary area corresponding to inter-brachial neuralgia with a DN4≥4 score.
  • Obtaining the signed written consent of the patient
  • Major patient affiliated to a social security scheme

Exclusion Criteria:

  • Contraindications specific to the treatments studied : capsaicine and pregabalin
  • Diabetic patient
  • Previous treatment with capsaicin or pregabalin
  • Opioid treatment> 80 mg / day (oral morphine equivalent) in progress- Topical treatment of pain between surgery and inclusion visit
  • Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 90 mmHg) or recent history (<3 months) of cardiovascular events (stroke, heart attack, pulmonary embolism)
  • Creatinine clearance (CLcr) <60mL / min according to the Cockcroft-Gault formula
  • Pregnant woman, likely to be pregnant or breastfeeding
  • Persons deprived of their liberty or guardianship (including curators),
  • Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794388


Contacts
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Contact: DENIS DUPOIRON, MD +33 241352873 denis.dupoiron@ico.unicancer
Contact: MARINE TIGREAT +33 240679900 marine.tigreat@ico.unicancer.fr

Locations
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France
Institut de Cancerologie de L'Ouest Recruiting
Angers, France, 49000
Contact: DENIS DUPOIRON, MD    +33 241352700 ext 2873    denis.dupoiron@ico.unicancer.fr   
Chu Grenoble Recruiting
Grenoble, France, 38700
Contact: Caroline MAINDET, MD       Cmaindetdominici@chu-grenoble.fr   
Chd Vendee Recruiting
La Roche-sur-Yon, France, 85025
Contact: Yves-Marie PLUCHON, MD       yves-marie.pluchon@chd-vendee.fr   
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Abesse AHMEIDI, MD       a-ahmeidi@o-lambret.fr   
Hopital Saitn Vincent de Paul Recruiting
Lille, France, 59020
Contact: Romain CHIQUET, MD       chiquet.romain@ghicl.net   
Centre Leon Berard Not yet recruiting
Lyon, France, 69008
Contact: Gisèle CHVETZOFF, MD       Gisele.chvetzoff@lyon.unicancer.fr   
CHU NICE Recruiting
Nice, France, 06003
Contact: Emilie PIQUET, MD       piquet.e@chu-nice.fr   
Institut Jean Godinot Recruiting
Reims, France, 51100
Contact: Olivier DUBROEUCQ, MD       Olivier.DUBROEUCQ@reims.unicancer.fr   
Institut Curie Not yet recruiting
Saint-Cloud, France, 92210
Contact: Marie PECHARD, MD       marie.pechard@curie.fr   
Iuct Oncopole Recruiting
Toulouse, France, 31052
Contact: Valérie MAURIES SAFFON, MD       mauries-saffon.valerie@iuct-oncopole.fr   
Ch Valenciennes Recruiting
Valenciennes, France, 53322
Contact: Antoine LEMAIRE       lemaire-a@ch-valenciennes.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Grünenthal GmbH
Investigators
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Study Director: DENIS DUPOIRON, MD Institut de Cancérologie de l'Ouest

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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT03794388     History of Changes
Other Study ID Numbers: ICO-A-2018-10
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Cancerologie de l'Ouest:
Breast cancer patient
Surgery
Inter Costobrachial Neuralgia
Additional relevant MeSH terms:
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Breast Neoplasms
Neuralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Capsaicin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipruritics
Dermatologic Agents