Radiodermatitis; AcuteRTSkinNCT04929808
Novel Skin Care Product for the Management of Acute Radiodermatitis
A study testing Hydrating emollient for acute radiodermatitis and Standard institutional skin care in people with Radiodermatitis; Acute and Radiation Dermatitis, run by Jessa Hospital at 1 site in Belgium.
Trial summary
Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiodermatitis; Acute, Radiation Dermatitis
- What is being tested?
- Hydrating emollient for acute radiodermatitis and Standard institutional skin care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2022to 13 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of breast cancer and underwent lumpectomy or mastectomy
- Scheduled for radiotherapy: hypofractionation regimen (16 or 16+5 boost fractions) at the Jessa Hospital (Hasselt, BE)
- Age ≥ 18 years
- Able to comply to the study protocol
- Able to sign written informed consent
- Signed written informed consent
Who cannot join
- Previous irradiation to the breast region
- Metastatic disease
- Patients with pre-existing skin rash, ulceration or open wound in the treatment area
- Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator •- Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients
Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new radiotherapy (RT) techniques. Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing RT.
Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the RTskin project, a novel emollient to tackle ARD has been developed.
The RTskin project general aim is to evaluate the efficacy of a novel skincare product to manage ARD in breast cancer patients.
Read the detailed description
Primary objective Evaluate the efficacy of a novel emollient for the management of ARD in comparison with the current standard of care in breast cancer patients
Secondary Objective 1 Compare the ARD-related symptoms of in breast cancer patients treated with the novel emollient and the standard institutional skin care.
Secondary Objective 2 Compare the dermatologic quality of life of in breast cancer patients treated with the novel emollient and the standard institutional skin care.
Secondary Objective 3 Correlate the severity of ARD with the applied RT parameters and personal - medical characteristics
- Conditions
- Radiodermatitis; Acute, Radiation Dermatitis
- Being tested
- Hydrating emollient for acute radiodermatitis, Standard institutional skin care
- Keywords
- Skin toxicity, Radiotherapy, Oncology, Skin care, Emollient
- Medical subject headings
- Radiodermatitis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrating emollient for acute radiodermatitisOther
The emollient has a calming effect, and hydrating and anti-oxidative properties.
An absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist.
Standard institutional skin careOther
The control patients will receive the institutional standard skin care, which includes the application of Flamigel® (Flen Pharma, Kontich, BELGIUM). In addition, Mepilex® (Mölnlycke Health Care, Berchem, Belgium), an absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Will receive the standard institutional skin care for acute radiodermatitis Receives: Other: Standard institutional skin care |
| Experimental group | Experimental | Will receive the novel, self-prepared skin care product Receives: Other: Hydrating emollient for acute radiodermatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin reaction evaluation
The patients skin reactions will be evaluated by the modified version of the RTOG criteria
Measured: Baseline
Skin reaction evaluation
The patients skin reactions will be evaluated by the modified version of the RTOG criteria
Measured: At fraction 15-16 of radiotherapy (week 3 )
Skin reaction evaluation
The patients skin reactions will be evaluated by the modified version of the RTOG criteria
Measured: At fraction 20-21 of radiotherapy (week 4) in case of a tumor boost
Secondary outcomes (13)
Patient subjective evaluation of skin reactions
The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale
Measured: Baseline
Patient subjective evaluation of skin reactions
The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale
Measured: Week 1 of radiotherapy
Patient subjective evaluation of skin reactions
The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale
Measured: Week 2 of radiotherapy
Patient subjective evaluation of skin reactions
The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale
Measured: At fraction 15/16 of radiotherapy (week 3)
Patient subjective evaluation of skin reactions
The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale
Measured: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
Quality of life assessment
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).
Measured: Baseline
Quality of life assessment
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).
Measured: At fraction 15/16 of radiotherapy (week 3)
Quality of life assessment
The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).
Measured: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
Patients' satisfaction with the therapeutic intervention
The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products. Furthermore, they will be asked to score their global satisfaction with the skin care products. All these items will be evaluated by using a numerical rating scale (NRS).
Measured: At fraction 15/16 of radiotherapy (week 3)
Patients' satisfaction with the therapeutic intervention
The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products. Furthermore, they will be asked to score their global satisfaction with the skin care products. All these items will be evaluated by using a numerical rating scale (NRS).
Measured: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
Pruritus evaluation
The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria
Measured: Baseline
Pruritus evaluation
The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria
Measured: At fraction 15/16 of radiotherapy (week 3)
Pruritus evaluation
The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria
Measured: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Feb 2022
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiodermatitis; AcuteStudies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University
- Responsible party
- Sponsor
- Investigators
- Jeroen Mebis, MD, PhD, Principal investigator, Jessa ziekenhuis VZW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929808
- Sponsor's protocol ID
- 2021/058
- Acronym
- RTSkin
- Status last verified
- Jul 2023
- First submitted
- 11 Jun 2021
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robijns J, Van Bever L, Hermans S, Claes M, Lodewijckx J, Lenaerts M, Tuts L, Vandaele E, Vinken E, Noe L, Verboven K, Maes A, Van de Velde AS, Bulens P, Bulens P, Van den Bergh L, Mebis J. A novel, multi-active emollient for the prevention of acute radiation dermatitis in breast cancer patients: a randomized clinical trial. Support Care Cancer. 2023 Oct 11;31(12):625. doi: 10.1007/s00520-023-08096-5.
PubMed 37819539
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04929808
- Acronym / sponsor ID
- RTSkin / 2021/058
- Conditions
- Radiodermatitis; Acute, Radiation Dermatitis
- Keywords
- Skin toxicity, Radiotherapy, Oncology, Skin care, Emollient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Collaborators
- Hasselt University
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 18 Jun 2021 (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.
Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new radiotherapy (RT) techniques. Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing RT.
Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the RTskin project, a novel emollient to tackle ARD has been developed.
The RTskin project general aim is to evaluate the efficacy of a novel skincare product to manage ARD in breast cancer patients.
Detailed description
Primary objective Evaluate the efficacy of a novel emollient for the management of ARD in comparison with the current standard of care in breast cancer patients
Secondary Objective 1 Compare the ARD-related symptoms of in breast cancer patients treated with the novel emollient and the standard institutional skin care.
Secondary Objective 2 Compare the dermatologic quality of life of in breast cancer patients treated with the novel emollient and the standard institutional skin care.
Secondary Objective 3 Correlate the severity of ARD with the applied RT parameters and personal - medical characteristics
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Standard institutional skin careWill receive the standard institutional skin care for acute radiodermatitis |
| Experimental group | Experimental | Other: Hydrating emollient for acute radiodermatitisWill receive the novel, self-prepared skin care product |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of breast cancer and underwent lumpectomy or mastectomy
- Scheduled for radiotherapy: hypofractionation regimen (16 or 16+5 boost fractions) at the Jessa Hospital (Hasselt, BE)
- Age ≥ 18 years
- Able to comply to the study protocol
- Able to sign written informed consent
Key exclusion criteria (4 listed)
- Previous irradiation to the breast region
- Metastatic disease
- Patients with pre-existing skin rash, ulceration or open wound in the treatment area
- Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator •- Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
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 |
|---|---|---|
| Hydrating emollient for acute radiodermatitisThe emollient has a calming effect, and hydrating and anti-oxidative properties. An absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist. | Other | Experimental group |
| Standard institutional skin careThe control patients will receive the institutional standard skin care, which includes the application of Flamigel® (Flen Pharma, Kontich, BELGIUM). In addition, Mepilex® (Mölnlycke Health Care, Berchem, Belgium), an absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist. | Other | Control group |
Primary outcome
Skin reaction evaluation
Time frame: Baseline
The patients skin reactions will be evaluated by the modified version of the RTOG criteria
Skin reaction evaluation
Time frame: At fraction 15-16 of radiotherapy (week 3 )
The patients skin reactions will be evaluated by the modified version of the RTOG criteria
Skin reaction evaluation
Time frame: At fraction 20-21 of radiotherapy (week 4) in case of a tumor boost
The patients skin reactions will be evaluated by the modified version of the RTOG criteria
13 secondary outcomes
Patient subjective evaluation of skin reactions
Time frame: Baseline
Patient subjective evaluation of skin reactions
Time frame: Week 1 of radiotherapy
Patient subjective evaluation of skin reactions
Time frame: Week 2 of radiotherapy
Patient subjective evaluation of skin reactions
Time frame: At fraction 15/16 of radiotherapy (week 3)
Patient subjective evaluation of skin reactions
Time frame: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
Quality of life assessment
Time frame: Baseline
Quality of life assessment
Time frame: At fraction 15/16 of radiotherapy (week 3)
Quality of life assessment
Time frame: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
Patients' satisfaction with the therapeutic intervention
Time frame: At fraction 15/16 of radiotherapy (week 3)
Patients' satisfaction with the therapeutic intervention
Time frame: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
Pruritus evaluation
Time frame: Baseline
Pruritus evaluation
Time frame: At fraction 15/16 of radiotherapy (week 3)
Pruritus evaluation
Time frame: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Derived from this study: PubMed 37819539Robijns J, Van Bever L, Hermans S, Claes M, Lodewijckx J, Lenaerts M, Tuts L, Vandaele E, Vinken E, Noe L, Verboven K, Maes A, Van de Velde AS, Bulens P, Bulens P, Van den Bergh L, Mebis J. A novel, multi-active emollient for the prevention of acute radiation dermatitis in breast cancer patients: a randomized clinical trial. Support Care Cancer. 2023 Oct 11;31(12):625. doi: 10.1007/s00520-023-08096-5.
- Individual participant dataSharing planned: No
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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.
Jeroen Mebis, MD, PhD principal investigator
Jessa ziekenhuis VZW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrating emollient for acute radiodermatitis and Standard institutional skin care in people with Radiodermatitis; Acute and Radiation Dermatitis, run by Jessa Hospital at 1 site in Belgium.
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 4 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: finished, as of the sponsor's last update on 13 Jul 2023. 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 Belgium. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin reaction evaluation (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04929808, which also lists 1 linked publication.
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 13 Jul 2023.