Head and Neck CancerMEDISKINNCT05588973
Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus
A study testing MEDISKIN cream and Panthenol cream in people with Head and Neck Cancer and Breast Cancer, run by Angelos Kassianos at 1 site in Cyprus.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Head and Neck Cancer, Breast Cancer
- What is being tested?
- MEDISKIN cream and Panthenol cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCyprus
- Study dates
- Dec 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Cyprus1 site
Cyprus University of Technology
Limassol, 3036
Angelos P. Kassianos, PhD, 0035725002252, angelos.kassianos@cut.ac.cy
About this study
Official title: Pilot Double-blind Randomized Controlled Clinical Trial for the Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus
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
- Being tested
- MEDISKIN cream, Panthenol cream
- Keywords
- cancer, breast cancer, quality of life, RCT
- Medical subject headings
- Head and Neck Neoplasms, Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDISKIN creamOther
MEDISKIN cream with collagen
Panthenol creamOther
Panthenol cream
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MEDISKIN cream |
| Control group | Placebo comparator | The group will be using panthenol istead of the MEDISKIN product Receives: Other: Panthenol cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (1 month before radiotherapy), during therapy (15 days), 1 week post therapy, 1 month later
Secondary outcomes (9)
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.
Measured: 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
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.
Measured: 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
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
Measured: During therapy (15 days)
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
Measured: During therapy (15 days)
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
Measured: During therapy (15 days)
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
Measured: During therapy (15 days)
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
Measured: During therapy (15 days)
Socio-demographic questionnaire
Developed for this study
Measured: Baseline (1 month before radiotherapy)
Acceptability questionnaire
Developed for this study with responses in open ended questions that will be analysed descriptively and thematically.
Measured: First day of therapy with Mediskin products (and after radiotherapy), 1 week post therapy, 1 month post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study startDec 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angelos Kassianos
- Sponsor type
- University, hospital or other
- Collaborators
- German Oncology Center, Cyprus, RSL Revolutionary Labs Ltd
- Responsible party
- Sponsor-investigator, Angelos Kassianos, Cyprus University of Technology
- Investigators
- Angelos P. Kassianos, PhD, Study chair, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588973
- Sponsor's protocol ID
- CUT_DN_02
- Other IDs
- RESTART 2016-2020 SEED
- Acronym
- MEDISKIN
- Status last verified
- Dec 2022
- First submitted
- 14 Oct 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Double-blind Randomized Controlled Clinical Trial for the Prevention of Radiodermatitis in Breast and Head and Neck Cancer Patients in Cyprus
- ClinicalTrials.gov ID
- NCT05588973
- Acronym / sponsor ID
- MEDISKIN / CUT_DN_02
- Conditions
- Head and Neck Cancer, Breast Cancer
- Keywords
- cancer, breast cancer, quality of life, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Angelos KassianosUniversity, hospital or other
- Collaborators
- German Oncology Center, Cyprus, RSL Revolutionary Labs Ltd
- Study start
- Dec 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: MEDISKIN cream50 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. |
| Control group | Placebo comparator | Other: Panthenol creamThe group will be using panthenol istead of the MEDISKIN product |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDISKIN creamMEDISKIN cream with collagen | Other | Intervention group |
| Panthenol creamPanthenol cream | Other | Control group |
Primary outcome
Dermatological Quality of Life
Time frame: Baseline (1 month before radiotherapy), during therapy (15 days), 1 week post therapy, 1 month later
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.
9 secondary outcomes
Dermatological Quality of Life (b)
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
Health Related Quality of Life
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
Real time quality of life
Time frame: During therapy (15 days)
Real time anxiety
Time frame: During therapy (15 days)
Real time depression
Time frame: During therapy (15 days)
Real time pain
Time frame: During therapy (15 days)
Real time fatigue
Time frame: During therapy (15 days)
Socio-demographic questionnaire
Time frame: Baseline (1 month before radiotherapy)
Acceptability questionnaire
Time frame: First day of therapy with Mediskin products (and after radiotherapy), 1 week post therapy, 1 month post baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelos P. Kassianos, PhD study chair
Cyprus University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEDISKIN cream and Panthenol cream in people with Head and Neck Cancer and Breast Cancer, run by Angelos Kassianos at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angelos P. Kassianos, PhD (0035725002252, angelos.kassianos@cut.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatological Quality of Life (time frame: Baseline (1 month before radiotherapy), during therapy (15 days), 1 week post therapy, 1 month later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.