Abstract
Background & Aims: There is strong evidence that >50% of patients undergoing chemotherapy are affected by peripheral polyneuropathy referred to as CIPN. Notably, up to 40% of these patients may develop a chronic neuropathy. A recent meta-analysis revealed that CIPN-associated neuropathic symptoms may persist in >80% of early breast cancer patients for 1-3 years after treatment. Considering the high survival prognosis of these patients, it appears essential to develop strategies that attenuate CIPN to increase their quality of life (QoL). Chemotherapeutic drugs such as paclitaxel and oxaliplatin produce neuropathic symptoms during or immediately after treatment. These drugs have been shown to potentiate thermosensitive receptors, sensitizing epidermal nociceptive terminals. Topical control of this sensitization may improve the sensory symptoms of CIPN and increase patients’ quality of life. A previous pilot study in a cohort of 27 patients with CIPN grades I/II showed that topical application of a formulation containing a thermosensitive receptor modulator (Oncapsisens®) relieved sensory symptoms and increased patients' dermatological QoL. Therefore, preventive modulation of nociceptive epidermal endings with Oncapsisens® may help delay the onset of CINP and decrease the intensity of sensitive symptoms. Methods: A randomized, double-blind study (hydrating cream (A) and nociceptive formulation Oncapsisens® (B) was approved by the Ethics Committees of participating hospitals. A cohort of 121 patients diagnosed with stage I-III breast cancer were included. Participants started a daily application of the assigned cream in hands. Upon appearance of sensory symptoms in hands or/and feet, participants applied the cream twice daily in hands and feet. Follow up of CIPN grade and adverse effects was conducted by oncologists, and quality of life questionnaires by sponsor. Differences between groups of qualitative variables were analyzed with the Fisher or Chi-square tests, and of quantitative variables with the non-parametric Wilcoxon signed-rank or Mann-Whitney rank tests. Results: 60% of participants with a variety of chemotherapeutic treatments containing taxanes and/or platins developed distal CIPN. Withdrawals were similar in both groups. Application of cream B significantly delayed the appearance of sensory neuropathic symptoms (66.7% cream B vs. 49% cream A), attenuated the incidence of CIPN in hands, and improve sensory symptoms according to the Leonard scale. We also observed a lower incidence trend of CIPN in patients using cream B. Both creams were satisfying to patients. Only 2 patients in both groups complained of pruritus and were withdrawn from the study. Conclusions: These findings suggest that topical modulation with a cream of nociceptor thermosensory sensitization delays the onset and improves CIPN symptoms.
Citation Format: Sonia Servitja, Maria Castro-Henriques, Iñaki Álvarez-Busto, Carlota Díez-Franco, Alba Medina-Castillo, Maria Asunción Algarra-García, Elena López-Miranda, Margaret Lario-Martínez, Maria Isabel Luengo-Alcázar, Miguel Borregón, Ana Davó, Anna Gassull-Delgado, Sara Roque-García, Ana Gonzaga-López, Jesus Manuel Poveda-Ferriols, Severine Pascal, Clotilde Ferrándiz-Huertas, Ana María Mitroi-Marinescu, Marta García-Escolano, Asia Fernández-Carvajal, Antonio Ferrer Montiel. Topical modulation of nociceptor epidermal terminals delays and ameliorates CIPN improving the quality of life of breast cancer patients [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P1-02-07.
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