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.

December 9, 2024 updated by: PROSPERA BIOTECH S.L.

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)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03202
        • Prospera Biotech,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory discomfort appearance in hands and/or feet as a measure of quality of life
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Discomfort Severity
Time Frame: Questionnaire was done every three weeks until one month after treatment was finished.

Once recruited volunteers start experiencing sensory skin discomfort in hands/feet and inform their oncologist, a Leonard Scale questionnaire was used to monitor these symptoms (The Leonard Scale1 consists of 14 questions that quantify the subjective intensity of each symptom (e.g. itch, stinging, pain…). Intensity is rated from 1-10, being 1 hardly any and 10 very much).

1. Leonard GD, Wright MA, Quinn MG, Fioravanti S, Harold N, Schuler B, Thomas RR, Grem JL. Survey of oxaliplatin-associated neurotoxicity using an interview-based questionnaire in patients with metastatic colorectal cancer. BMC Cancer. 2005 Sep 16;5:116. doi: 10.1186/1471-2407-5-116. PMID: 16168057; PMCID: PMC1266024.
Questionnaire was done every three weeks until one month after treatment was finished.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PROSPERA BIOTECH S.L.

Collaborators

Hospital General Universitario Elche
Hospital Universitario Ramon y Cajal
Hospital del Mar
Hospital General Universitario Santa Lucia
Universidad Miguel Hernandez de Elche
Centre Hospitalier Universitaire Saint Pierre
Hospital Miguel Servet
Hospital Universitari Sagrat Cor, Barcelona
Hospital General de Elda
Hospital Marina Baixa, Alicante

Investigators

  • Principal Investigator: 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Actual)

September 24, 2024

Study Completion (Actual)

October 16, 2024

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Estimated)

December 13, 2024

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-PB02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data on the anonymised patients such as treatment, number of cycles, sex, age and morbidities during the study could be shared with reviwers or researchers.

IPD Sharing Time Frame

From July of 2022 to July 2027

IPD Sharing Access Criteria

Upon request to Prospera Biotech, researchers and doctors will be able to access it. Additional information will be available for peer-reviewers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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