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Completed

NCT Number: NCT02334345

Skin Protection During Radiotherapy in Patients With Breast Cancer

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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Key information

Conditions

Radiation Dermatitis Dermatitis Radiation Injuries Radiodermatitis Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU LIMOGES - Radiothérapie

Limoges, 87000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evoskin

Drug

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

Trixiera

Drug

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

Primary outcomes

  1. Average of the radiation dermatitis intensity

    Time frame: at 3 months

    Radiation dermatitis will be assessed by means of a spectrophotometer after the patient has received 50Gy

Secondary outcomes

  1. Clinical grade of dermatitis

    Time frame: at 3 months

    dermatitis grade will be assessed according to CTCAE after the patient has received 50 Gy

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

Skin Protection During Radiotherapy in Patients With Breast Cancer: A Comparative Study of Evoskin® Verus Trixéra®

Acronym: EVOSKIN

Important dates

Study start
2015
Primary completion
2015
Study completion
2021
First posted
Jan 8, 2015
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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