A randomized trial of two creams in the skin care of patients receiving radiation therapy for breast cancer in the tropics

Is CavilonTM Durable Barrier Cream (treatment) more effective than 100% Pure Sorbolene Cream (control) at preventing moist desquamation in patients receiving radiation treatment to the breast in a tropical setting?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000784819

Enrollment

255

Registered

2012-07-24

Start date

2010-07-12

Completion date

2012-08-14

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to compare two proven skin care products (creams) in the context of patients undergoing radiation therapy for breast cancer in the tropics. Who is it for? you may be eligible to join this study if you are aged 18 years or older and are undergoing radiation treatment at the Radiation Oncology Unit, The Townsville Hospital, for cancer of the breast. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will apply CavilonTM Durable Barrier Cream twice per day to the radiation therapy treatment area from the first day of treatment up until 4 weeks following the end of the radiation therapy. Participants in the other group will use 100% Pure Sorbolene cream instead. Participants will be assessed weekly during treatment and at one month post treatment in order to identify if one cream is more effective than the other at preventing skin reactions associated with radiation therapy for breast cancer.

Interventions

Treatment: CavilonTM Durable Barrier Cream (active ingredient Dimethicone 1.3%), applied twice per day to radiation therapy treatment area. Applications to commence on first radiation therapy treatment day and continue for 4 weeks post completion of radiation therapy treatment (approximately 8-10 weeks).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients undergoing radiation treatment at the Radiation Oncology Unit, The Townsville Hospital, for cancer of the breast, and who: 1. Are 18 years or older, and 2. Are able to read, write, and speak English and able to comprehend and follow the study instructions, and 3. Are willing to consent to their inclusion in the study.

Exclusion criteria

Patients undergoing radiation treatment at the Radiation Oncology Unit, The Townsville Hospital, for cancer of the breast, and who: 1. Are undergoing radiation therapy for palliative reasons, and/or 2. Have specific breast lesions that receive treatment that differs significantly in terms of dosage and duration to the routine regimen, and/or 3. Have a known allergy to either Sorbolene or Cavilon cream, and/or 4. Are unable to provide their written consent owing to an intellectual or mental impairment, and/or 5. Are deemed by the Radiation Oncologist to be not suitable to be invited to participate in the study, and/or 6. Decline to participate.

Outcome results