Radiation Dermatitis
Conditions
Keywords
Radiation Dermatitis, Urtica comp.
Brief 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.
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.
Interventions
DRUGUrtica comp. 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.
DRUGinstitutional standard skin care Excipial-Hydrolotion
The institutional standard skin care Excipial-Hydrolotion is available to all patients
Sponsors
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized parallel design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Radiation therapy for Breast Cancer * Age \>= 18 years * Written informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Radiation Dermatitis (RD) measured by the CTCAE | 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 | During the whole study (six weeks of therapy plus follow-up of six weeks) | Comparison between both arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with secondary skin infection / need of topical and systemic antibiotics | During the whole study (six weeks of therapy plus follow-up of six weeks) | Comparison between both arms |
| Patients quality of life measured by the Skindex | During the whole study (six weeks of therapy plus follow-up of six weeks) | Comparison between both arms. |
| Percentage of patients requiring no additional therapy for RD (e.g. Flammazine or Ialugen plus) | During the whole study (six weeks of therapy plus follow-up of six weeks) | Comparison between both arms measuring the use of Flammazine or Ialugen plus (rescue-care) |
| Patients evaluation of the treatment (Skin condition) measured by visual analog scale (VAS) | During the whole study (six weeks of therapy plus follow-up of six weeks) | 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). |
| Patients evaluation of the treatment (satisfaction) measured by the FACIT-TS-G (total scale) | EOT (=time point specifically at end of 6 weeks of radiation therapy) | 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). |
| Percentage of patients RD free at end of therapy (EOT) measured by the CTCAE | EOT (=time point specifically at end of 6 weeks of radiation therapy) | Comparison between both arms |
Countries
Switzerland
Outcome results
None listed