Loading search results
CAPTRANE
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
Sponsor study identifier
interventional
140
1 country
11
Study Start
March 19, 2019
Actual (reported)Primary Completion
November 18, 2022
Actual (reported)Study Completion
November 18, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 18, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 5, 2018
Actual (reported)January 7, 2019
Actual (reported)March 19, 2019
Actual (reported)November 18, 2022
Actual (reported)November 18, 2022
Actual (reported)May 5, 2026
Actual (reported)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: * 0 indicates no pain, * 10 indicates the worst imaginable pain. Higher scores represent worse pain. The score was collected at 2 months
2 months
Change From Baseline to 6 Months in Neuropathic Pain Score (Numeric Rating Scale 0-10)
6 months
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.
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.
Application of capsaicin patches at 8% on painful area
Taking Pregabalin tablets
Institut de Cancerologie de L'Ouest
Angers, 49000, France
Chu Grenoble
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
DENIS DUPOIRON, MD
Institut de Cancérologie de l'Ouest
140 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2018
First Posted
January 7, 2019
Study Start
March 19, 2019
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Institut Jean Godinot
Reims, 51100, France
Institut Curie
Saint-Cloud, 92210, France
Iuct Oncopole
Toulouse, 31052, France
Ch Valenciennes
Valenciennes, 53322, France
Primary Completion
November 18, 2022
Actual (reported)Study Completion
November 18, 2022
Actual (reported)Last Updated
May 5, 2026
Results First Posted
May 5, 2026
Record last verified: 2026-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: