Evidence map›Paper›PMID 41032160›Full record

Trial reportClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2026

A topical nociceutical formulation ameliorates chemotherapy-induced peripheral neuropathy: a pilot randomized clinical study.

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 and 11 more

Erratum issuedAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Sonia ServitjaServicio de Oncología Médica, Hospital del Mar, 08003, Barcelona, Spain. sservitja@psmar.cat.
Maria Castro-HenriquesServicio de Oncología Médica, Hospital del Mar, 08003, Barcelona, Spain.
Iñaki Álvarez-BustoServicio de Oncología Médica, Hospital Universitario Miguel Servet, 50009, Saragossa, Spain.
Carlota Díez-FrancoServicio de Oncología Médica, Hospital Universitario Miguel Servet, 50009, Saragossa, Spain.
Alba Medina-CastilloServicio de Oncología Médica, Hospital Universitario Miguel Servet, 50009, Saragossa, Spain.
Maria Asunción Algarra-GarcíaServicio de Oncología Médica, Hospital Marina Baixa, 03570, Villajoyosa, Alicante, Spain.
Elena López-MirandaServicio de Oncología Médica, Hospital Universitario Ramon y Cajal, 28034, Madrid, Spain.
Margaret Lario-MartínezServicio de Oncología Médica, Hospital Universitario Ramon y Cajal, 28034, Madrid, Spain.
Maria Isabel Luengo-AlcázarServicio de Oncología Médica, Hospital General Universitario Santa Lucía, 30202, Cartagena, Murcia, Spain.
Miguel BorregónServicio de Oncología Médica, Hospital General Universitario de Elche, 03202, Elche , Alicante, Spain.
Ana DavóServicio de Oncología Médica, Hospital General Universitario de Elche, 03202, Elche , Alicante, Spain.
Anna Gasull-DelgadoServicio de Oncología Médica, Hospital Universitari Sagrat Cor, 08029, Barcelona, Spain.
Sara Roque-GarcíaServicio de Oncología Médica, Hospital Universitari Sagrat Cor, 08029, Barcelona, Spain.
Ana Gonzaga-LópezServicio de Oncología Médica, Hospital General Universitario de Elche, 03202, Elche , Alicante, Spain.
Jesús Manuel Poveda-FerriolsCHU St-Pierre-UMC St-Pieter, 1000, Brussels, Belgium.
Severine PascalCHU St-Pierre-UMC St-Pieter, 1000, Brussels, Belgium.
Ana María Mitroi-MarinescuScientific Park, Prospera Biotech, University Miguel Hernández, 03202, Elche, SL, Spain.
Marta García-EscolanoScientific Park, Prospera Biotech, University Miguel Hernández, 03202, Elche, SL, Spain.
Asia Fernández-CarvajalInstituto de Investigación, Desarrollo E Innovación en Biotecnología Sanitaria de Elche (IDiBE), Universidad Miguel Hernández, 03202, Elche, Spain.
Clotilde Ferrándiz-HuertasScientific Park, Prospera Biotech, University Miguel Hernández, 03202, Elche, SL, Spain.
Antonio Ferrer-MontielInstituto de Investigación, Desarrollo E Innovación en Biotecnología Sanitaria de Elche (IDiBE), Universidad Miguel Hernández, 03202, Elche, Spain. aferrer@umh.es.ORCID http://orcid.org/0000-0002-2973-6607

Funding

Conselleria de Innovación, Universidades, Ciencia y Sociedad Digital, Generalitat Valenciana PROMETEO/2021/031Ministerio de Ciencia, Innovación y Universidades PID2021-126423OB-C21
6 · The paper itself

Abstract

backgroundUp to 80% of patients undergoing taxanes or platinum-based chemotherapy (CT) develop a peripheral polyneuropathy (CIPN), that affects treatment compliance and quality of life (QoL). CIPN is characterized by a remarkable sensitization of peripheral nociceptive endings. We performed a proof-of-concept, double-blind, randomized, two-arms, multicenter clinical study to evaluate if protecting epidermal nociceptive endings with a topical nociceutical formulation prevented CIPN and augmented QoL during CT. MATERIAL AND

methodsParticipants started a daily topical application of the assigned formulation in hands (moisturizing or nociceutical). Upon appearance of neuropathic symptoms in hands or feet, they applied the creams twice daily. Diagnosis and follow-up of CIPN was performed using the CTC AE v5.0 criteria.

resultsA cohort of 142 patients treated with taxanes and/or platinum agents were randomly distributed into the arms. Withdrawals were similar in both arms. A lower CIPN incidence in hands was observed in the nociceutical arm (32% vs 13%, p = 0.03), while a similar number of participants developed CIPN in feet (73% vs 67%, p = 0.1). Interestingly, the nociceutical formulation increased the number of CT cycles CIPN free (6 vs 8 cycle, p = 0.009). The Leonard Scale Questionnaire revealed that 60% of patients using the moisturizing cream reported frequently bothersome neuropathic symptoms, compared with only 39% in the nociceutical group (p = 0.0017).

conclusionProtection of nociceptive epidermal terminals with a topical nociceutical formulation reduced the incidence of CIPN in hands and increased the QoL of patients. These findings provide a solid ground for a confirmatory clinical study.

Indexed as

Antineoplastic AgentsPeripheral Nervous System DiseasesAdministration, TopicalAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedNeoplasmsPilot ProjectsQuality of LifeTaxoidsAntineoplastic AgentsTaxoidsCapsaicinCIPNEpidermal endingsNeuropathyNociception

Identifiers

PMID41032160
PMCPMC12920311

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.