Radiation DermatitisPhase 2UrticacompNCT03494205
Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis
A Phase 2 study testing Urtica comp. gel and institutional standard skin care "Excipial-Hydrolotion" in people with Radiation Dermatitis, run by University of Bern at 1 site in Switzerland.
Trial summary
A randomized controlled trial comparing Urtica comp. gel (Swissmedic listed medication in the category of "Anthroposophic Medication without Indication") against standard skin care, examining its effect in prevention and treatment of radiation dermatitis in breast cancer patients under Radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- Urtica comp. gel and institutional standard skin care "Excipial-Hydrolotion"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 May 2018to 10 Feb 2022
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiation therapy for Breast Cancer
- Age >= 18 years
- Written informed consent
Who cannot join
- Ulcerated cancer at beginning of radiation therapy
- Skin lesions in the radiation area before start of radiation therapy
- Known allergies, hypersensitivity or reactions against one of the constituents of the investigational product [5]
- Any neurological or psychiatric conditions that, in the evaluation of the treating physician, deem the patient incapable to participate in the study
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) as judged by the PI
- The following criteria are exclusion criteria for the conduct of the radiation therapy, which is prerequisite for inclusion into the study. Thus, such patients will anyway not meet the inclusion criteria and are explicitly excluded from participation:
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- Women who are pregnant or breast feeding
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis (An Interdisciplinary, Interprofessional Phase II Randomized Controlled Trial in Patients With Breast Cancer)
A randomized controlled trial comparing Urtica comp. gel (Swissmedic listed medication in the category of "Anthroposophic Medication without Indication") against standard skin care, examining its effect in prevention and treatment of radiation dermatitis in breast cancer patients under Radiation therapy.
Read the detailed description
Radiation dermatitis is one of the most common side effects of radiotherapy for cancer and affects around 95 % of patients receiving radiotherapy. Patients with breast cancer as well as patients with head and neck cancer are most frequently affected, due to the higher radiation dose to the skin, as compared to other cancer types.
Radiation dermatitis has a profound impact on the quality of a patient's life, due to pain and discomfort. Skin lesions bear a marked risk of infection. In addition, all these issues may be the cause of interruption of radiation therapy, resulting in inadequate disease treatment.
Despite a plentitude of studies researching local and systemic therapeutic approaches, currently no treatment (aside from local steroids which bear substantial side-effects) can be explicitly recommended.
Thus, further research, especially in therapeutic options with a positive side-effect spectrum would be highly beneficial.
Urtica comp. gel is a Swissmedic registered medication. It is e.g. applied in first and second-degree burn and scalding as well as sunburn and has been used in over 80 years with an excellent safety profile. Positive clinical experience in treating radiation dermatitis with Urtica comp. gel suggest studying this therapeutic option in a pilot trial.
- Conditions
- Radiation Dermatitis
- Being tested
- Urtica comp. gel, institutional standard skin care "Excipial-Hydrolotion"
- Keywords
- Radiation Dermatitis, Urtica comp.
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urtica comp. gelDrug
Also called Wund- und Brand Gel
Urtica comp. gel is a Swissmedic registered medication. The scope of application of Urtica comp. is an imbalanced, affected process of skin-regeneration, in particular when stemming from an overdose of heat or light.
It is applied in first and second-degree burn and scalding, sunburn, allergic and hyperergic (excessive) skin conditions (dermatoses), insect bites, abrasions and ulcers.
institutional standard skin care "Excipial-Hydrolotion"Drug
Also called Excipial
The institutional standard skin care "Excipial-Hydrolotion" is available to all patients
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | For the patients of the test-group Urtica comp gel is applied three times per day locally on the skin as soon as the patient senses "itching, tingling" and/or reddening. Otherwise the skincare is exactly as the control group in line with the departments general guidelines.
In case of marked worsening, e.g. epitheliolysis, the patient may receive "Flammazine and Ialugen plus" as rescue-care.
Rescue care: according to the departments therapeutic guidelines patients will receive "Flammazine and/or Ialugen plus" as clinically indicated at the discretion of the treating physician (usually in cases of marked worsening of the skin condition like e.g. epitheliolysis). Receives: Drug: Urtica comp. gel |
| Control group | Active comparator | Control group receiving the institutional standard skin care "Excipial-Hydrolotion" - all other therapeutic interventions, assessments and rescue-care will be the same in both groups. Receives: Drug: institutional standard skin care "Excipial-Hydrolotion" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Radiation Dermatitis (RD) measured by the CTCAE
Comparison between both arms
Measured: During the whole study (six weeks of therapy plus follow-up of six weeks)
Severity of RD measured by the CTCAE
Comparison between both arms
Measured: During the whole study (six weeks of therapy plus follow-up of six weeks)
Secondary outcomes (6)
Percentage of patients requiring no additional therapy for RD (e.g. Flammazine or Ialugen plus)
Comparison between both arms measuring the use of Flammazine or Ialugen plus (rescue-care)
Measured: During the whole study (six weeks of therapy plus follow-up of six weeks)
Percentage of patients RD free at end of therapy (EOT) measured by the CTCAE
Comparison between both arms
Measured: EOT (=time point specifically at end of 6 weeks of radiation therapy)
Percentage of patients with secondary skin infection / need of topical and systemic antibiotics
Comparison between both arms
Measured: During the whole study (six weeks of therapy plus follow-up of six weeks)
Patients quality of life measured by the Skindex
Comparison between both arms.
Measured: During the whole study (six weeks of therapy plus follow-up of six weeks)
Patients evaluation of the treatment (satisfaction) measured by the FACIT-TS-G (total scale)
Comparison between both arms. The FACIT-TS-G (Functional Assessment of Chronic Illness Therapy treatment satisfaction - General) assesses the patients treatment satisfaction at the end of therapy (EOT after 6 weeks of Radiation therapy).
The questionnaire consists of 8 questions, 3 of which are answered on a scale ranging from 0 (much worse) to 4 (much better), 3 questions ranging from 0 (not al all) to 3 (totally) and two questions which can be answered with 0 (no), 1(maybe) and 2 (yes). Thus on all scales a higher value represents a better outcome. The total score range is 0 (not satisfied at all) to 25 (highly satisfied).
Measured: EOT (=time point specifically at end of 6 weeks of radiation therapy)
Patients evaluation of the treatment (Skin condition) measured by visual analog scale (VAS)
with the Skin Condition VAS the patient self-assesses the skin condition in the radiation area.
The questionnaire consists of 5 subscales: pain, itching, burning, irritation, visual appearance. Each scale ranges from 0 (not apparent) to 100 (worst possible expression). For the total score all values are summed up and divided by 5 (number of scales) resulting in a total score ranging from 0 (best possible outcome = no skin affection due to radiation) to 100 (worst possible outcome).
Measured: During the whole study (six weeks of therapy plus follow-up of six weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start2 May 2018
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized parallel design
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ursula Wolf, Study director, University Bern, Institution of Complementary MedicineNikola Cihoric, MD PhD, Principal investigator, University Bern, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494205
- Sponsor's protocol ID
- 211820931
- Acronym
- Urticacomp
- Status last verified
- May 2022
- First submitted
- 22 Feb 2018
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Patient data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urtica Comp. Gel for Prevention and Therapy of Radiation Dermatitis (An Interdisciplinary, Interprofessional Phase II Randomized Controlled Trial in Patients With Breast Cancer)
- ClinicalTrials.gov ID
- NCT03494205
- Acronym / sponsor ID
- Urticacomp / 211820931
- Conditions
- Radiation Dermatitis
- Keywords
- Radiation Dermatitis, Urtica comp.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 11 Apr 2018 (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.
A randomized controlled trial comparing Urtica comp. gel (Swissmedic listed medication in the category of "Anthroposophic Medication without Indication") against standard skin care, examining its effect in prevention and treatment of radiation dermatitis in breast cancer patients under Radiation therapy.
Detailed description
Radiation dermatitis is one of the most common side effects of radiotherapy for cancer and affects around 95 % of patients receiving radiotherapy. Patients with breast cancer as well as patients with head and neck cancer are most frequently affected, due to the higher radiation dose to the skin, as compared to other cancer types.
Radiation dermatitis has a profound impact on the quality of a patient's life, due to pain and discomfort. Skin lesions bear a marked risk of infection. In addition, all these issues may be the cause of interruption of radiation therapy, resulting in inadequate disease treatment.
Despite a plentitude of studies researching local and systemic therapeutic approaches, currently no treatment (aside from local steroids which bear substantial side-effects) can be explicitly recommended.
Thus, further research, especially in therapeutic options with a positive side-effect spectrum would be highly beneficial.
Urtica comp. gel is a Swissmedic registered medication. It is e.g. applied in first and second-degree burn and scalding as well as sunburn and has been used in over 80 years with an excellent safety profile. Positive clinical experience in treating radiation dermatitis with Urtica comp. gel suggest studying this therapeutic option in a pilot trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized parallel design
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Urtica comp. gelFor the patients of the test-group Urtica comp gel is applied three times per day locally on the skin as soon as the patient senses "itching, tingling" and/or reddening. Otherwise the skincare is exactly as the control group in line with the departments general guidelines. In case of marked worsening, e.g. epitheliolysis, the patient may receive "Flammazine and Ialugen plus" as rescue-care. Rescue care: according to the departments therapeutic guidelines patients will receive "Flammazine and/or Ialugen plus" as clinically indicated at the discretion of the treating physician (usually in cases of marked worsening of the skin condition like e.g. epitheliolysis). |
| Control group | Active comparator | Drug: institutional standard skin care "Excipial-Hydrolotion"Control group receiving the institutional standard skin care "Excipial-Hydrolotion" - all other therapeutic interventions, assessments and rescue-care will be the same in both groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Radiation therapy for Breast Cancer
- Age >= 18 years
- Written informed consent
Key exclusion criteria (9 listed)
- Ulcerated cancer at beginning of radiation therapy
- Skin lesions in the radiation area before start of radiation therapy
- Known allergies, hypersensitivity or reactions against one of the constituents of the investigational product [5]
- Any neurological or psychiatric conditions that, in the evaluation of the treating physician, deem the patient incapable to participate in the study
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) as judged by the PI
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 |
|---|---|---|
| Urtica comp. gelAlso: Wund- und Brand GelUrtica comp. gel is a Swissmedic registered medication. The scope of application of Urtica comp. is an imbalanced, affected process of skin-regeneration, in particular when stemming from an overdose of heat or light. It is applied in first and second-degree burn and scalding, sunburn, allergic and hyperergic (excessive) skin conditions (dermatoses), insect bites, abrasions and ulcers. | Drug | Test group |
| institutional standard skin care "Excipial-Hydrolotion"Also: ExcipialThe institutional standard skin care "Excipial-Hydrolotion" is available to all patients | Drug | Control group |
Primary outcome
Incidence of Radiation Dermatitis (RD) measured by the CTCAE
Time frame: During the whole study (six weeks of therapy plus follow-up of six weeks)
Comparison between both arms
Severity of RD measured by the CTCAE
Time frame: During the whole study (six weeks of therapy plus follow-up of six weeks)
Comparison between both arms
6 secondary outcomes
Percentage of patients requiring no additional therapy for RD (e.g. Flammazine or Ialugen plus)
Time frame: During the whole study (six weeks of therapy plus follow-up of six weeks)
Percentage of patients RD free at end of therapy (EOT) measured by the CTCAE
Time frame: EOT (=time point specifically at end of 6 weeks of radiation therapy)
Percentage of patients with secondary skin infection / need of topical and systemic antibiotics
Time frame: During the whole study (six weeks of therapy plus follow-up of six weeks)
Patients quality of life measured by the Skindex
Time frame: During the whole study (six weeks of therapy plus follow-up of six weeks)
Patients evaluation of the treatment (satisfaction) measured by the FACIT-TS-G (total scale)
Time frame: EOT (=time point specifically at end of 6 weeks of radiation therapy)
Patients evaluation of the treatment (Skin condition) measured by visual analog scale (VAS)
Time frame: During the whole study (six weeks of therapy plus follow-up of six weeks)
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 27 May 2022.
- Individual participant dataSharing planned: No. Individual Patient data will not be shared.
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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.
Ursula Wolf study director
University Bern, Institution of Complementary Medicine
Nikola Cihoric, MD PhD principal investigator
University Bern, Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Urtica comp. gel and institutional standard skin care "Excipial-Hydrolotion" in people with Radiation Dermatitis, run by University of Bern at 1 site in Switzerland.
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 3 inclusion and 9 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 27 May 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 Switzerland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of Radiation Dermatitis (RD) measured by the CTCAE (time frame: During the whole study (six weeks of therapy plus follow-up of six weeks)). The study lists 2 primary outcomes in all. 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 27 May 2022.