Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-31

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Head and Neck Cancer Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Intervention group

50 patients will be randomized to the MEDISKIN group and 50 to the panthenol group. Everyone will start using their cream from the start of the treatment and will continue for 2 weeks after the end of the radiation therapy (twice a day). If there are cases of patients using panthenol and it is deemed necessary based on symptoms to use MEDISKIN then they will automatically change group. Before starting to use the skin cosmetic products, patients will be asked to test the product for any allergic reactions. The "mini-patch test" which is standard of practice is carried out by using the substance on the inner elbow or wrist for 24 hours and observing for any reactions.

Group Type EXPERIMENTAL

MEDISKIN cream

Intervention Type OTHER

MEDISKIN cream with collagen

Control group

The group will be using panthenol istead of the MEDISKIN product

Group Type PLACEBO_COMPARATOR

Panthenol cream

Intervention Type OTHER

Panthenol cream

Interventions

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MEDISKIN cream

MEDISKIN cream with collagen

Intervention Type OTHER

Panthenol cream

Intervention Type OTHER

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No