Clinical trial NCT06733545: 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.
Official title: Study for the Evaluation of the Degree of Skin Satisfaction of Cosmetics Creams PB-011 and PB-012 for Sensitive Skin in Oncological Patients Affected by a Palmoplantar Polyneuropathy Secondary to Chemotherapy or Chemotherapeutic Agents' Fusion to Monoclonal Antibodies (Immunocitostatics)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life (QOL)
CIPN - Chemotherapy-Induced Peripheral Neuropathy
Keywords: CIPN
Sensitive skin
Quality of life
Chemotherapy
Chemotherapy skin side effects
palmoplantar discomfort
Lead sponsor: PROSPERA BIOTECH S.L.
Sponsor class: INDUSTRY
Collaborators: name: Hospital General Universitario Elche
name: Hospital Miguel Servet
name: Hospital del Mar
name: Hospital Marina Baixa, Alicante
name: Hospital Universitario Ramon y Cajal
name: Hospital General Universitario Santa Lucia
name: Hospital Universitari Sagrat Cor, Barcelona
name: Hospital General de Elda
name: Centre Hospitalier Universitaire Saint Pierre
name: Universidad Miguel Hernandez de Elche
First posted: 2024-12-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: This proof-of-concept clinical trial is a multicenter, double-blind, randomized, placebo-controlled research project approved by the ethics committees of all participating hospitals. Medical oncologists have been responsible for recruiting volunteers, checking that they meet the inclusion and exclusion criteria, obtaining signed informed consent, completing the data collection booklet and collecting the occurrence of CIPN and the degree of CIPN, along with patient follow-up. Once informed consent has been signed, the patients are provided with a PB-011 or the PB-012 formulation and started a daily application on their hands. After the onset of sensory symptoms on hands and/or feet, participants applied the cream twice daily on hands and feet and began responding questionnaires to evaluate the severity of sensorial symptoms.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sensory discomfort appearance in hands and/or feet as a measure of quality of life
timeFrame: 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:
measure: Skin Discomfort Severity
timeFrame: Questionnaire was done every three weeks until one month after treatment was finished.
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Prospera Biotech,
state: Alicante
Study officials:
affiliation: Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)
name: Antonio Sonia Servitja, Oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)
name: Maria Castro-Henriques, Oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Oncología Médica, Hospital Universitario Miguel Servet, 50009 Zaragoza (Spain)
name: Iñaki Álvarez-Busto, Oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Oncología Médica, Hospital Marina Baixa, 03570 Villajoyosa, Alicante (Spain)
name: Maria Asunción Algarra-García, Oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Oncología Médica, Hospital Universitario Ramon y Cajal, 28034 Madrid (Spain)
name: Elena López-Miranda, Oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Oncología Médica, Hospital General Universitario Santa Lucía, 30202 Cartagena, Murcia (Spain)
name: Maria I Luengo-Alcázar, Oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Oncología Médica, Hospital General Universitario de Elche, 03202 Elche, Alicante (Spain)
name: Miguel Borregón, Oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Oncología Médica, Hospital Universitari Sagrat Cor, 08029 Barcelona (Spain)
name: Anna Gassull-Delgado, Nursery
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Oncología Médica, Hospital General Universitario de Elda, 03600 Elda, Alicante (Spain)
name: Ana Gonzaga-López, Oncologist
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU St-Pierre-UMC St-Pieter, 1000 Brussels (Belgium)
name: Jesus M Poveda-Ferriols, Oncologist
role: PRINCIPAL_INVESTIGATOR
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