Skin Protection During Radiotherapy in Patients With Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2021-01-17

Brief Summary

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Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. In the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.

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Detailed Description

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Women with breast cancer and were to receive breast radiotherapy to 50 Gy were enrolled in a prospective randomized trial to compare the effectiveness of Evoskin®) for protecting skin compared to Trixiera. To account for individual differences in radiation each subject served as her own control, as each was to apply the experimental and control agents to the irradiated breast. Each patient was randomly assigned to use Evoskin on the half of the irradiated breast and to use the Triexiera on the other half. Dermatitis was graded weekly by means of a spectrophotometer.

Conditions

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Radiation Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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EVOSKIN

Patients are to apply Evoskin ( topical agent) in the half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day.

Group Type EXPERIMENTAL

Evoskin

Intervention Type DRUG

Evoskin is Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions

TRIXIERA

Patients are to apply Trixiera ( topical agent) in the other half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day.

Group Type ACTIVE_COMPARATOR

Trixiera

Intervention Type DRUG

Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions

Interventions

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Evoskin

Evoskin is Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions

Intervention Type DRUG

Trixiera

Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years old or more
* Patients with breast cancer for which a treatment by radiotherapy is planned
* No concomitant chemotherapy
* Signed informed consent

Exclusion Criteria

* Cutaneous neoplasia radiotherapy
* Total mastectomy
* Bilateral breast cancer
* Dark skinDiseases enhancing radiosensitivity Patient with a generalized skin disorder
* Pregnant, breast-feeding woman

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No