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.

NCT06733545 | Completed

• 1 other identifier: 20-PB02
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

It is proposed a controlled research study aimed to evaluating and comparing the degree of skin satisfaction and comfort with cosmetic creams PB-011 and PB-012 in cancer patients who can develop a palmar and plantar peripheral polyneuropathy by treatment with chemotherapy. Both products are cosmetic creams derived from the cosmetic Nocisens® line (for the care of sensitive skin with atopic tendency). The hypothesis that is proposed to test is that the care with PB-011 or PB-012 of the sensitive skin associated with palmar and plantar peripheral polyneuropathy of cancer patients will increase their degree of satisfaction and skin comfort. This study is proposed in patients who are going to start chemotherapeutic treatment. The study conceives two populations: (i) population where PB-011 cream will be tested; and (ii) population that will test PB-012 cream. A sample size of 60 volunteers per population has been estimated to ensure statistical significance. As a qualitative relevant variable for patients, the degree of satisfaction and skin comfort of the volunteers will be assessed by means of questionnaires.

Conditions

Quality of Life (QOL); CIPN - Chemotherapy-Induced Peripheral Neuropathy

Keywords

CIPN; Sensitive skin; Quality of life; Chemotherapy; Chemotherapy skin side effects; palmoplantar discomfort

Outcome Measures

Primary Outcomes (1)

• Sensory discomfort appearance in hands and/or feet as a measure of quality of life

  The appearance of sensory sensations resulting from CIPN will be detected by the oncologists' follow-up. The oncologists will indicate the treatment cycle in which the neuropathy discomfort appears and their degree in the data collection notebook. The study involves following the patient from the first cycle of chemotherapy until one month after the end of treatment.

  The estimated period of time over which the event is assessed is up to16 weeks, which correspond from the first CT cycle (cycles are received once a week, 12 CT cycles) up to one month later.

Secondary Outcomes (1)

• Skin Discomfort Severity

  Questionnaire was done every three weeks until one month after treatment was finished.

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population was anyone over 18 years of age who met the inclusion and exclusion criteria and who was about to start chemotherapy treatment.

You may qualify if:

• To be older than 18 year old
• 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

You may not qualify if:

• Not being or having been treated with antidepressants, antiepileptics or HIV medication in the last 3 months
• 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.

Sponsors & Collaborators

• PROSPERA BIOTECH S.L.: lead
• Hospital General Universitario Elche: collaborator
• Hospital Miguel Servet: collaborator
• Hospital del Mar: collaborator
• Hospital Marina Baixa, Alicante: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital General Universitario Santa Lucia: collaborator
• Hospital Universitari Sagrat Cor, Barcelona: collaborator
• Hospital General de Elda: collaborator
• Centre Hospitalier Universitaire Saint Pierre: collaborator
• Universidad Miguel Hernandez de Elche: collaborator

Study Sites (1)

Prospera Biotech,

Elche, Alicante, 03202, Spain

Location

Related Publications (16)

• 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.

  PMID: 34676514 BACKGROUND

• 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.

  PMID: 38660386 BACKGROUND

• 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.

  PMID: 28580836 BACKGROUND

• 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.

  PMID: 33420359 BACKGROUND

• 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.

  PMID: 29722529 BACKGROUND

• 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.

  PMID: 35871491 BACKGROUND

• 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.

  PMID: 35102580 BACKGROUND

• 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.

  PMID: 28620280 BACKGROUND

• 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.

  PMID: 31724334 BACKGROUND

• 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.

  PMID: 37993030 BACKGROUND

• 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.

  PMID: 38060077 BACKGROUND

• 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.

  PMID: 35167004 BACKGROUND

• 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.

  PMID: 24733808 BACKGROUND

• 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.

  PMID: 25261162 BACKGROUND

• 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.

  PMID: 26282635 BACKGROUND

• 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.

  PMID: 34655433 BACKGROUND

Study Officials

• Antonio Sonia Servitja, Oncologist

  Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)

  PRINCIPAL INVESTIGATOR

• Maria Castro-Henriques, Oncologist

  Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)

  PRINCIPAL INVESTIGATOR

• Iñaki Álvarez-Busto, Oncologist

  Servicio de Oncología Médica, Hospital Universitario Miguel Servet, 50009 Zaragoza (Spain)

  PRINCIPAL INVESTIGATOR

• Maria Asunción Algarra-García, Oncologist

  Servicio de Oncología Médica, Hospital Marina Baixa, 03570 Villajoyosa, Alicante (Spain)

  PRINCIPAL INVESTIGATOR

• Elena López-Miranda, Oncologist

  Servicio de Oncología Médica, Hospital Universitario Ramon y Cajal, 28034 Madrid (Spain)

  PRINCIPAL INVESTIGATOR

• Maria I Luengo-Alcázar, Oncologist

  Servicio de Oncología Médica, Hospital General Universitario Santa Lucía, 30202 Cartagena, Murcia (Spain)

  PRINCIPAL INVESTIGATOR

• Miguel Borregón, Oncologist

  Servicio de Oncología Médica, Hospital General Universitario de Elche, 03202 Elche, Alicante (Spain)

  PRINCIPAL INVESTIGATOR

• Anna Gassull-Delgado, Nursery

  Servicio de Oncología Médica, Hospital Universitari Sagrat Cor, 08029 Barcelona (Spain)

  PRINCIPAL INVESTIGATOR

• Ana Gonzaga-López, Oncologist

  Servicio de Oncología Médica, Hospital General Universitario de Elda, 03600 Elda, Alicante (Spain)

  PRINCIPAL INVESTIGATOR

• Jesus M Poveda-Ferriols, Oncologist

  CHU St-Pierre-UMC St-Pieter, 1000 Brussels (Belgium)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 13, 2024
• Study Start: April 4, 2022
• Primary Completion: September 24, 2024
• Study Completion: October 16, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: From July of 2022 to July 2027
• Access Criteria: Upon request to Prospera Biotech, researchers and doctors will be able to access it. Additional information will be available for peer-reviewers.

Locations

ES (1)