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.

PROSPERA BIOTECH S.L.120 enrolled

Overview

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.

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

120

Conditions

Quality of Life (QOL)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

Skin Discomfort Severity

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.

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