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Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus (MEDISKIN)

Primary Purpose

Head and Neck Cancer, Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
MEDISKIN cream
Panthenol cream
Sponsored by
Angelos Kassianos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring cancer, breast cancer, quality of life, RCT

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • Cyprus University of Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

The group will be using panthenol istead of the MEDISKIN product

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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
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
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
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
Socio-demographic questionnaire
Developed for this study
Acceptability questionnaire
Developed for this study with responses in open ended questions that will be analysed descriptively and thematically.

Full Information

First Posted
October 14, 2022
Last Updated
December 5, 2022
Sponsor
Angelos Kassianos
Collaborators
German Oncology Center, Cyprus, RSL Revolutionary Labs Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05588973
Brief Title
Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Angelos Kassianos
Collaborators
German Oncology Center, Cyprus, RSL Revolutionary Labs Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Breast Cancer
Keywords
cancer, breast cancer, quality of life, RCT

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The group will be using panthenol istead of the MEDISKIN product
Intervention Type
Other
Intervention Name(s)
MEDISKIN cream
Intervention Description
MEDISKIN cream with collagen
Intervention Type
Other
Intervention Name(s)
Panthenol cream
Intervention Description
Panthenol cream
Primary Outcome Measure Information:
Title
Dermatological Quality of Life
Description
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.
Time Frame
Baseline (1 month before radiotherapy), during therapy (15 days), 1 week post therapy, 1 month later
Secondary Outcome Measure Information:
Title
Dermatological Quality of Life (b)
Description
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.
Time Frame
Baseline (1 month before radiotherapy), First day of therapy with Mediskin products (and after radiotherapy), During therapy (15 days), 1 week post therapy
Title
Health Related Quality of Life
Description
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.
Time Frame
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
Title
Real time quality of life
Description
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
Time Frame
During therapy (15 days)
Title
Real time anxiety
Description
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
Time Frame
During therapy (15 days)
Title
Real time depression
Description
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
Time Frame
During therapy (15 days)
Title
Real time pain
Description
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
Time Frame
During therapy (15 days)
Title
Real time fatigue
Description
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
Time Frame
During therapy (15 days)
Title
Socio-demographic questionnaire
Description
Developed for this study
Time Frame
Baseline (1 month before radiotherapy)
Title
Acceptability questionnaire
Description
Developed for this study with responses in open ended questions that will be analysed descriptively and thematically.
Time Frame
First day of therapy with Mediskin products (and after radiotherapy), 1 week post therapy, 1 month post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angelos P. Kassianos, PhD
Phone
0035725002252
Email
angelos.kassianos@cut.ac.cy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelos P. Kassianos, PhD
Organizational Affiliation
Cyprus University of Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Cyprus University of Technology
City
Limassol
ZIP/Postal Code
3036
Country
Cyprus
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelos P. Kassianos, PhD
Phone
0035725002252
Email
angelos.kassianos@cut.ac.cy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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