Study for the Evaluation of the Degree of Skin Satisfaction of a Cosmetic Cream for Sensitive Skin in Oncological Patients Affected by a Palmoplantar Polyneuropathy Secondary to Chemotherapy.
NCT ID: NCT06733545
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
120 participants
OBSERVATIONAL
2022-04-04
2024-10-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PB-011
Patients starting chemotherapy treatment are given (double blinded) moisturizing cream PB-011 to use once a day in hands. If sensory discomfort appears in hands or feet, the dosage could be increased up to twice a day in hands and feet.
No interventions assigned to this group
PB-012
Patients undergoing chemotherapy treatment are given (double blinded) moisturizing cream PB-012 to use once a day in hands. If sensory discomfort appears in hands or feet, the dosage could be increased up to twice a day in hands and feet.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* To be able to complete questionnaires
* Give informed consent in writing
* Being able to apply the product under test by oneself
* To have been diagnosed with stage I-III primary cancer
* To have received a maximum of one treatment session with chemotherapy (derivatives of taxane, platinum or vincristines)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Life expectancy greater than or equal to 6 months
Exclusion Criteria
* Pre-existing peripheral neuropathies not related to chemotherapy treatment
* Pre-existing neurodegenerative or neuromuscular disease or history of stroke
* Family history of neuropathic diseases
* Having suffered in the last 6 months: myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization or class III/IV heart failure.
* Being receiving investigational treatment (being involved in a clinical trial
* Evidence or indication of metastasis affecting the Central Nervous System
* Use of immunosuppressive or immunomodulatory medication that may lead to immunodeficiencies
* Not being treated with topical palmar and/or plantar medication
* Known hypersensitivity to capsaicin
* Having reduced capacity for expression or response to forms
* Not have been under general anesthesia for at least one month before starting the study
* Complication of peripheral polyneuropathy symptoms that require the use of specific medication.
18 Years
ALL
No
Sponsors
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Hospital General Universitario Elche
OTHER
Hospital Miguel Servet
OTHER
Hospital del Mar
OTHER
Hospital Marina Baixa, Alicante
UNKNOWN
Hospital Universitario Ramon y Cajal
OTHER
Hospital General Universitario Santa Lucia
OTHER
Hospital Universitari Sagrat Cor, Barcelona
UNKNOWN
Hospital General de Elda
OTHER
Centre Hospitalier Universitaire Saint Pierre
OTHER
Universidad Miguel Hernandez de Elche
OTHER
PROSPERA BIOTECH S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Antonio Sonia Servitja, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)
Maria Castro-Henriques, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)
Iñaki Álvarez-Busto, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Servicio de Oncología Médica, Hospital Universitario Miguel Servet, 50009 Zaragoza (Spain)
Maria Asunción Algarra-García, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Servicio de Oncología Médica, Hospital Marina Baixa, 03570 Villajoyosa, Alicante (Spain)
Elena López-Miranda, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Servicio de Oncología Médica, Hospital Universitario Ramon y Cajal, 28034 Madrid (Spain)
Maria I Luengo-Alcázar, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Servicio de Oncología Médica, Hospital General Universitario Santa Lucía, 30202 Cartagena, Murcia (Spain)
Miguel Borregón, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Servicio de Oncología Médica, Hospital General Universitario de Elche, 03202 Elche, Alicante (Spain)
Anna Gassull-Delgado, Nursery
Role: PRINCIPAL_INVESTIGATOR
Servicio de Oncología Médica, Hospital Universitari Sagrat Cor, 08029 Barcelona (Spain)
Ana Gonzaga-López, Oncologist
Role: PRINCIPAL_INVESTIGATOR
Servicio de Oncología Médica, Hospital General Universitario de Elda, 03600 Elda, Alicante (Spain)
Jesus M Poveda-Ferriols, Oncologist
Role: PRINCIPAL_INVESTIGATOR
CHU St-Pierre-UMC St-Pieter, 1000 Brussels (Belgium)
Locations
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Prospera Biotech,
Elche, Alicante, Spain
Countries
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References
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Bae EH, Greenwald MK, Schwartz AG. Chemotherapy-Induced Peripheral Neuropathy: Mechanisms and Therapeutic Avenues. Neurotherapeutics. 2021 Oct;18(4):2384-2396. doi: 10.1007/s13311-021-01142-2. Epub 2021 Oct 21.
Chen X, Gan Y, Au NPB, Ma CHE. Current understanding of the molecular mechanisms of chemotherapy-induced peripheral neuropathy. Front Mol Neurosci. 2024 Apr 10;17:1345811. doi: 10.3389/fnmol.2024.1345811. eCollection 2024.
Aromolaran KA, Goldstein PA. Ion channels and neuronal hyperexcitability in chemotherapy-induced peripheral neuropathy; cause and effect? Mol Pain. 2017 Jan-Dec;13:1744806917714693. doi: 10.1177/1744806917714693.
Nikolaeva-Koleva M, Butron L, Gonzalez-Rodriguez S, Devesa I, Valente P, Serafini M, Genazzani AA, Pirali T, Ballester GF, Fernandez-Carvajal A, Ferrer-Montiel A. A capsaicinoid-based soft drug, AG1529, for attenuating TRPV1-mediated histaminergic and inflammatory sensory neuron excitability. Sci Rep. 2021 Jan 8;11(1):246. doi: 10.1038/s41598-020-80725-z.
Serafini M, Griglio A, Aprile S, Seiti F, Travelli C, Pattarino F, Grosa G, Sorba G, Genazzani AA, Gonzalez-Rodriguez S, Butron L, Devesa I, Fernandez-Carvajal A, Pirali T, Ferrer-Montiel A. Targeting Transient Receptor Potential Vanilloid 1 (TRPV1) Channel Softly: The Discovery of Passerini Adducts as a Topical Treatment for Inflammatory Skin Disorders. J Med Chem. 2018 May 24;61(10):4436-4455. doi: 10.1021/acs.jmedchem.8b00109. Epub 2018 May 15.
Marcotti A, Fernandez-Trillo J, Gonzalez A, Vizcaino-Escoto M, Ros-Arlanzon P, Romero L, Vela JM, Gomis A, Viana F, de la Pena E. TRPA1 modulation by Sigma-1 receptor prevents oxaliplatin-induced painful peripheral neuropathy. Brain. 2023 Feb 13;146(2):475-491. doi: 10.1093/brain/awac273.
Villalba-Riquelme E, de la Torre-Martinez R, Fernandez-Carvajal A, Ferrer-Montiel A. Paclitaxel in vitro reversibly sensitizes the excitability of IB4(-) and IB4(+) sensory neurons from male and female rats. Br J Pharmacol. 2022 Jul;179(14):3693-3710. doi: 10.1111/bph.15809. Epub 2022 Mar 7.
Starobova H, Vetter I. Pathophysiology of Chemotherapy-Induced Peripheral Neuropathy. Front Mol Neurosci. 2017 May 31;10:174. doi: 10.3389/fnmol.2017.00174. eCollection 2017.
Wang DS, Wang ZQ, Chen G, Peng JW, Wang W, Deng YH, Wang FH, Zhang JW, Liang HL, Feng F, Xie CB, Ren C, Jin Y, Shi SM, Fan WH, Lu ZH, Ding PR, Wang F, Xu RH, Li YH. Phase III randomized, placebo-controlled, double-blind study of monosialotetrahexosylganglioside for the prevention of oxaliplatin-induced peripheral neurotoxicity in stage II/III colorectal cancer. Cancer Med. 2020 Jan;9(1):151-159. doi: 10.1002/cam4.2693. Epub 2019 Nov 13.
Gewandter JS, Culakova E, Davis JN, Gada U, Guido JJ, Bearden JD, Burnette B, Shah D, Morrow GR, Mustian K, Sluka KA, Mohile N. Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Proof-of-Concept Randomized Clinical Trial. J Pain. 2024 May;25(5):104431. doi: 10.1016/j.jpain.2023.11.014. Epub 2023 Nov 21.
Accordino MK, Lee S, Leu CS, Levin B, Trivedi MS, Crew KD, Kalinsky K, Raghunathan R, Faheem K, Harden E, Taboada A, de Oliveira BD, Larson E, Franks L, Honan E, Law C, Hershman DL. Randomized adaptive selection trial of cryotherapy, compression therapy, and placebo to prevent taxane-induced peripheral neuropathy in patients with breast cancer. Breast Cancer Res Treat. 2024 Feb;204(1):49-59. doi: 10.1007/s10549-023-07172-y. Epub 2023 Dec 7.
Mezzanotte JN, Grimm M, Shinde NV, Nolan T, Worthen-Chaudhari L, Williams NO, Lustberg MB. Updates in the Treatment of Chemotherapy-Induced Peripheral Neuropathy. Curr Treat Options Oncol. 2022 Jan;23(1):29-42. doi: 10.1007/s11864-021-00926-0. Epub 2022 Feb 15.
Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14.
Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
Pachman DR, Qin R, Seisler DK, Smith EM, Beutler AS, Ta LE, Lafky JM, Wagner-Johnston ND, Ruddy KJ, Dakhil S, Staff NP, Grothey A, Loprinzi CL. Clinical Course of Oxaliplatin-Induced Neuropathy: Results From the Randomized Phase III Trial N08CB (Alliance). J Clin Oncol. 2015 Oct 20;33(30):3416-22. doi: 10.1200/JCO.2014.58.8533. Epub 2015 Aug 17.
Burgess J, Ferdousi M, Gosal D, Boon C, Matsumoto K, Marshall A, Mak T, Marshall A, Frank B, Malik RA, Alam U. Chemotherapy-Induced Peripheral Neuropathy: Epidemiology, Pathomechanisms and Treatment. Oncol Ther. 2021 Dec;9(2):385-450. doi: 10.1007/s40487-021-00168-y. Epub 2021 Oct 16.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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20-PB02
Identifier Type: -
Identifier Source: org_study_id