Clinical trial NCT05588973: Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus
Official title: Pilot Double-blind Randomized Controlled Clinical Trial for the Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Breast Cancer
Keywords: cancer
breast cancer
quality of life
RCT
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
Collaborators: name: German Oncology Center, Cyprus
name: RSL Revolutionary Labs Ltd
First posted: 2022-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study is a double-blinded pilot randomized controlled trial with skin cosmetic products aimed at breast and head and neck cancer patients who will undergo radiation therapy. For the study, individuals will be sought from the German Oncology Center of Limassol. The study will include 80 patients of the German Oncology Center who will be diagnosed with breast cancer and will undergo radiotherapy and 20 patients with head and neck cancer who will also undergo radiotherapy. Individuals included in the study will be over 18 years of age and will have signed written consent to participate in the program. This study will involve 100 patients. Patients will be randomized, (giving a number to each patient) into 2 homogeneous groups of 50 people, either to the control group using panthenol (placebo), or to the intervention group using MEDISKIN.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The treatment of cancer as a multidimensional disease has improved in recent years with the development of new chemotherapies, targeted biological therapies or radiation therapy protocols and have led to an overall improvement in the survival of oncology patients. These treatments often cause adverse effects on the skin, which can be accompanied by physical and mental suffering and have a significant impact on patients' quality of life. Improving the quality of life of patients is today a therapeutic challenge. The objective of this clinical study is to assess the tolerability of an innovative skin cosmetic product that will be developed specifically for use during curative anticancer treatments, as well as to study the impact on quality of life of skin side effects caused by the treatments.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age,
* understand and be able to provide signed consent for the purpose of the research,
* be diagnosed with breast or head and neck cancer,
* undergo subfractionated radiotherapy of the breast in 15 sessions of a total dose of 40-42Gy, with or without the administration of a booster dose (boost),
* to know the Greek or English language well
* any wound should have healed after radiotherapy. The criteria will be evaluated by the medical staff of the hospital.

Exclusion Criteria:

* those who do not meet the aforementioned inclusion criteria as well as:
* those who suffer from inflammatory cancer,
* those who have untreated wounds and/or other serious dermatological problems
* those with severe/extensive burns
* those who suffer from serious mental disorders (dementia, drug addiction, etc.) that require intensive treatment or monitoring,
* those who have a sensitivity/allergy to any of the product's ingredients. The criteria will be evaluated by the medical staff of the hospital.

Primary outcomes:
measure: Dermatological Quality of Life
timeFrame: Baseline (1 month before radiotherapy), during therapy (15 days), 1 week post therapy, 1 month later
Secondary outcomes:
measure: Dermatological Quality of Life (b)
timeFrame: Baseline (1 month before radiotherapy), First day of therapy with Mediskin products (and after radiotherapy), During therapy (15 days), 1 week post therapy
measure: Health Related Quality of Life
timeFrame: Baseline (1 month before radiotherapy), First day of therapy with Mediskin products (and after radiotherapy), during therapy (15 days), 1 week post therapy, 1 month later
measure: Real time quality of life
timeFrame: During therapy (15 days)
measure: Real time anxiety
timeFrame: During therapy (15 days)
measure: Real time depression
timeFrame: During therapy (15 days)
measure: Real time pain
timeFrame: During therapy (15 days)
measure: Real time fatigue
timeFrame: During therapy (15 days)
measure: Socio-demographic questionnaire
timeFrame: Baseline (1 month before radiotherapy)
measure: Acceptability questionnaire
timeFrame: First day of therapy with Mediskin products (and after radiotherapy), 1 week post therapy, 1 month post baseline
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: Cyprus University of Technology
Study officials:
affiliation: Cyprus University of Technology
name: Angelos P. Kassianos, PhD
role: STUDY_CHAIR
References: