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

Breast Cancer Clinical Trial

— MEDISKIN  

Official title:

Pilot Double-blind Randomized Controlled Clinical Trial for the Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05588973
• Other study ID #: CUT_DN_02
• Secondary ID: RESTART 2016-202
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: Cyprus University of Technology
• Contact: Angelos P. Kassianos, PhD
• Phone: 0035725002252
• Email: angelos.kassianos[@]cut.ac.cy
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Radiodermatitis

Intervention

Other:
• MEDISKIN cream
MEDISKIN cream with collagen
• Panthenol cream
Panthenol cream

Locations

Country	Name	City	State
Cyprus	Cyprus University of Technology	Limassol

Sponsors (3)

Lead Sponsor	Collaborator
Angelos Kassianos	German Oncology Center, Cyprus, RSL Revolutionary Labs Ltd

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dermatological Quality of Life (b)	Dermatology Quality of Life Index Questionnaire | The Dermatological Quality of Life Index (DLQI) is a tool often used by dermatologists to assess the impact of skin disease on quality of life in areas such as work and social activities, as well as patients' symptoms and feelings about their pathological condition. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life is reduced/affected. DLQI can also be expressed as a percentage of the maximum possible score of 30 (ie % of 30). There will be 3 measurements during treatment one every 5 days.	Baseline (1 month before radiotherapy), First day of therapy with Mediskin products (and after radiotherapy), During therapy (15 days), 1 week post therapy
Secondary	Health Related Quality of Life	EORTC QLQ-C30 Questionnaire | European Organization for Research and Treatment of Cancer Questionnaire that assesses the quality of life of cancer patients (EORTC QLQ - C30) (Aaronson et al 1993, Osaba et al 1994). We will use the validated Greek version of this result version 3. The questionnaire is summed through a specific algorithm into 4 categories: physical function, psychological function, social function and a series of symptoms such as pain, fatigue, etc. A higher score in each means better functioning (in functioning subpscales), better quality of life (in the global quality of life subscale) and worse symptoms (in symptomatology sub-scales). The change in measurement will be used both with the end of treatment as well as 1 month later.	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
Secondary	Real time quality of life	To better understand the patient's condition during the treatment we will use a mobile application (PRICE EMA app) which was created by researchers of the University of Cyprus, Cyprus University of Technology and CYENS with the data stored in a GDPR compliant cloud based system accessible only through codes and encoded to match the redcap data. We will measure quality of life using an adapted version of the EORTC QLQ C30 global quality of life subscale with a higher score on a 0-100 scale indicating better quality of life, through brief self-reports that patients will complete through in-app notifications. The development of the PRICE methodology and tool is explained here: https://dl.acm.org/doi/abs/10.1145/3491101.3503562?casa_token=_pSlJoCNphIAAAAA:RMI4xGtq2J-T9BJHqDjAU3R-pVx3OdqR0gIRAvNLBHuP6c8gt3YRRO4CryevCopqBOVAZQ-X7_7	During therapy (15 days)
Secondary	Real time anxiety	To better understand the patient's condition during the treatment we will use a mobile application (PRICE EMA app) which was created by researchers of the University of Cyprus, Cyprus University of Technology and CYENS with the data stored in a GDPR compliant cloud based system accessible only through codes and encoded to match the redcap data. We will measure anxiety through brief self-reports that patients will complete through in-app notifications using an adapted version of the anxiety sub scale of Hospital Anxiety and Depression Scale (HADS) with higher scores on a 0-21 score indicating higher levels of anxiety symptoms. The development of the PRICE methodology and tool is explained here: https://dl.acm.org/doi/abs/10.1145/3491101.3503562?casa_token=_pSlJoCNphIAAAAA:RMI4xGtq2J-T9BJHqDjAU3R-pVx3OdqR0gIRAvNLBHuP6c8gt3YRRO4CryevCopqBOVAZQ-X7_7	During therapy (15 days)
Secondary	Real time depression	To better understand the patient's condition during the treatment we will use a mobile application (PRICE EMA app) which was created by researchers of the University of Cyprus, Cyprus University of Technology and CYENS with the data stored in a GDPR compliant cloud based system accessible only through codes and encoded to match the redcap data. We will measure depression through brief self-reports that patients will complete through in-app notifications using an adapted version of HADS with higher scores on a 0-21 score indicating worse depression symptomatology. The development of the PRICE methodology and tool is explained here: https://dl.acm.org/doi/abs/10.1145/3491101.3503562?casa_token=_pSlJoCNphIAAAAA:RMI4xGtq2J-T9BJHqDjAU3R-pVx3OdqR0gIRAvNLBHuP6c8gt3YRRO4CryevCopqBOVAZQ-X7_7	During therapy (15 days)
Secondary	Real time pain	To better understand the patient's condition during the treatment we will use a mobile application (PRICE EMA app) which was created by researchers of the University of Cyprus, Cyprus University of Technology and CYENS with the data stored in a GDPR compliant cloud based system accessible only through codes and encoded to match the redcap data. We will measure pain/irritation through brief self-reports developed for this study that patients will complete through in-app notifications with a higher score on a 0-10 score indicating worse pain symptoms. The development of the PRICE methodology and tool is explained here: https://dl.acm.org/doi/abs/10.1145/3491101.3503562?casa_token=_pSlJoCNphIAAAAA:RMI4xGtq2J-T9BJHqDjAU3R-pVx3OdqR0gIRAvNLBHuP6c8gt3YRRO4CryevCopqBOVAZQ-X7_7	During therapy (15 days)
Secondary	Real time fatigue	To better understand the patient's condition during the treatment we will use a mobile application (PRICE EMA app) which was created by researchers of the University of Cyprus, Cyprus University of Technology and CYENS with the data stored in a GDPR compliant cloud based system accessible only through codes and encoded to match the redcap data. We will measure fatigue through brief self-reports developed for this study that patients will complete through in-app notifications with a higher score on a 0-10 score indicating worse fatigue symptoms. The development of the PRICE methodology and tool is explained here: https://dl.acm.org/doi/abs/10.1145/3491101.3503562?casa_token=_pSlJoCNphIAAAAA:RMI4xGtq2J-T9BJHqDjAU3R-pVx3OdqR0gIRAvNLBHuP6c8gt3YRRO4CryevCopqBOVAZQ-X7_7	During therapy (15 days)
Secondary	Socio-demographic questionnaire	Developed for this study	Baseline (1 month before radiotherapy)
Secondary	Acceptability questionnaire	Developed for this study with responses in open ended questions that will be analysed descriptively and thematically.	First day of therapy with Mediskin products (and after radiotherapy), 1 week post therapy, 1 month post baseline