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

NCT05588973 | Unknown DMC

• 2 other identifiers: CUT_DN_02RESTART 2016-2020 SEED
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Breast Cancer

Keywords

cancer; breast cancer; quality of life; RCT

Outcome Measures

Primary Outcomes (1)

• Dermatological Quality of Life

  Questionnaire SKINDEX-17 \| The Skindex-17 is a dermatological HRQoL instrument that was derived from the Skindex-29 using Rasch psychometric analysis. It consists of 17 items instead of 29, and answers are given on a four-point scale instead of a five-point scale. The tool offers 2 measures: psychosocial health and symptomatology with higher scores reporting increased quality of life and symptomatology respectively. Change in dermatological quality of life immediately after treatment will be used as the primary outcome.

  Baseline (1 month before radiotherapy), during therapy (15 days), 1 week post therapy, 1 month later

Secondary Outcomes (9)

• Dermatological Quality of Life (b)

  Baseline (1 month before radiotherapy), First day of therapy with Mediskin products (and after radiotherapy), During therapy (15 days), 1 week post therapy

• Health Related Quality of Life

  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

• Real time quality of life

  During therapy (15 days)

• Real time anxiety

  During therapy (15 days)

• Real time depression

  During therapy (15 days)

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: MEDISKIN cream

Control group

PLACEBO COMPARATOR

The group will be using panthenol istead of the MEDISKIN product

Other: Panthenol cream

Interventions

MEDISKIN cream OTHER

MEDISKIN cream with collagen

Intervention group

Panthenol cream OTHER

Panthenol cream

Control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angelos Kassianos: lead
• German Oncology Center, Cyprus: collaborator
• RSL Revolutionary Labs Ltd: collaborator

Study Sites (1)

Cyprus University of Technology

Limassol, 3036, Cyprus

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Angelos P. Kassianos, PhD

  Cyprus University of Technology

  STUDY CHAIR

Central Study Contacts

Angelos P. Kassianos, PhD

CONTACT

0035725002252; angelos.kassianos@cut.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 20, 2022
• Study Start: December 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

CY (1)