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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Sensory discomfort appearance in hands and/or feet as a measure of quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Sensory discomfort appearance in hands and/or feet as a measure of quality of life
时间窗: 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.
次要结局
- Skin Discomfort Severity(Questionnaire was done every three weeks until one month after treatment was finished.)