CompletedPhase 3ACTRN12612000949886

Mepitel Film for the prevention of skin ulceration caused by radiation therapy in breast cancer patients.

The efficacy of Mepitel Film in preventing radiation-induced moist desquamation in breast cancer patients.


Sponsor

University of Otago

Enrollment

80 participants

Start Date

Oct 24, 2012

Study Type

Interventional

Conditions

Summary

Breast cancer is the most common malignancy for women in New Zealand. Severe skin reactions occur in a significant proportion of women who receive radiation therapy for breast cancer. Skin ulceration affects patient quality of life and poses a risk of infection. There is currently no standard treatment for radiation-induced skin reactions. We have shown in two trials in New Zealand that Mepilex Lite dressings decrease the severity of acute radiation-induced skin reactions. Both trials were intra-patient controlled randomized trials, whereby each patient acted as their own control, circumventing the problem of the many confounding treatment-and patient-related factors that affect the severity of such skin reactions. However, the dressing were not transparent and did not stick well in the armpit and underneath the breast. Mepitel Film has all the advantages of Mepilex Lite but is transparent, sticks better and stays on for longer. This study will compare the efficacy of Mepitel Film with that of aqueous cream in reducing the incidence of radiation-induced skin ulceration in 40 women treated for breast cancer.


Eligibility

Sex: Both males and females

Inclusion Criteria1

  • Patients who receive radiation therapy for breast cancer.

Exclusion Criteria3

  • Previous radiation therapy to the chest
  • Metastatic disease
  • Inability to attend follow up sessions

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Interventions

Patients who are to be treated with radiation therapy for breast cancer will be invited to particiate in this trial. At the start of radiation treatment the chest area to be irradiated will be divide

Patients who are to be treated with radiation therapy for breast cancer will be invited to particiate in this trial. At the start of radiation treatment the chest area to be irradiated will be divided into a medial and lateral half (containing the axilla). Each half will be randomized to either the treatment or the control arm. Treatment Arm 1. Mepitel Film will be placed on the skin area randomized to the treatment arm by the research radiation therapist. Film will be replaced when necessary (approximately every 1 or 2 weeks). 2. Radiation therapy will be given through the Film, due to the extremely small bolus effect. 3. The Film will remain in place for the duration of RT treatment and after completion of radiation therapy treatment until the skin reactions resolve fully. Control Arm 1. Aqueous cream will be applied by the patient twice a day to treat the control skin areas. Trial Endpoint: moist desquamation When moist desquamation occurs in either the Mepitel Film or control patches, the skin will be treated as per department protocol.


Locations(1)

South Island, Dunedin, New Zealand

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ACTRN12612000949886