Objective: determine whether a Likert-type scale scoring system, specified for skin irritation reactions (erythema, itching, burning sensation of skin and general irritation of skin) can function as a tool to score the radiation-induced dermatitis…
ID
Source
Brief title
Condition
- Injuries by physical agents
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Development of a tool to document patients* experience of the severity and
duration of skin reactions after radiotherapy, using a Likert-type scoring
system.
2. Determination of inter-patient variation, as a pilot to calculate the
number of patients required for a comparative clinical study.
Secondary outcome
1. To assess if the Lickert-type score documented by the patient is comparable
to the severity of the side effects evaluated by the investigator at the end of
radiation therapy.
2. To assess any relationship to patient or treatment related factors to the
recorded parameters of patient symptoms.
3. To obtain feedback from patients regarding the utility of topical
symptomatic treatment of their radiation dermatitis
Background summary
Radiation skin toxicity is poorly documented and little is known about the
extent to which skin reactions cause distress or have impact on daily life. The
management of radiation skin reactions is controversial, and often based on
anecdotal evidence. Furthermore, it is known from previous trials that here is
a large inter-patient variation in the degree of erythema developing as a
result of radiotherapy to the chest wall in breast cancer patients. .
Study objective
Objective: determine whether a Likert-type scale scoring system, specified for
skin irritation reactions (erythema, itching, burning sensation of skin and
general irritation of skin) can function as a tool to score the
radiation-induced dermatitis as experienced by patients whilst on radiotherapy
for breast cancer. Further, to determine the inter-patient variation for the
Likert-type parameter scores, to enable calculation of patient numbers required
in a subsequent comparative trial. The influence of patient related and
treatment related factors on the Likert-type scores will be evaluated.
Study design
This study is a single-center, open-label, non randomized prospective pilot
study in patients with radiation-induced skin reactions during radiotherapy
for breast cancer. Patients will be asked te fill in a questionnair (with a
Likert-type scale) once a week during the radiotherapy and and at 4 weeks
after finishing radiotherapy. The standard advice for the management of
radiation-induced skin reactions of the NKI-AVL will be given for skin care
during the radiation period.
Study burden and risks
The use of creams, and other topical treatments can be considered as supportive
care for radiation dermatitis, intended to relieve symptoms of itching and
irritation. The most important side effect associated with the use of creams is
a contact dermatitis as a reaction to one of the components. This is rare and
difficult to distinguish from radiation-induced dermatitis, unless it extends
outside the radiation field.
This study will be carried out in a patient group treated for breast cancer.
However, an effective symptomatic treatment for radiation dermatitis is also
relevant for other radiation sites, especially with the increasing use of
chemo-radiation, for example in the head and neck area, high dose lung cancer
treatments, and pelvic malignancies.
Plesmanlaan 121
1066 CX Amsterdam
NL
Plesmanlaan 121
1066 CX Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Female patients undergoing external beam radiotherapy for breast cancer.
Total prescribed dose 40 Gy or more
Irradiation of one or more of the following target areas: breast, chest wall, regional lymph nodes.
Patient can apply creams
Patient able to understand and complete the questionnaire.
patiente is willing to sign informed consent
Exclusion criteria
Postoperative wound infection within treatment area;
Ulceration or open wound in treatment area;
History of skin diseases in the irradiated area;
Any clinical significant medical condition that could interfere with the conduct of the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31855.031.11 |