Postoperative Radiotherapy Breast Cancer Clinical Trial
Official title:
Randomized, Blinded Phase III Trial Comparing Calendula Officinalis Cream With Standard Aqueous Cream "Essex" for Treatment of Skin Reactions Caused by Postoperative Radiotherapy of Breast Cancer
| Verified date | September 2015 |
| Source | Karolinska University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medical Products Agency |
| Study type | Interventional |
Acute radiation skin reactions (ARSR) occur in the majority of patients undergoing
postoperative radiotherapy (RT). Some patients experience more severe reactions such as dry
and/or moist desquamation but most patients experience mild reactions e.g. erythema (Lopez
et al., 2005). The radiation dose, volume, RT technique and previous treatment, such as type
of surgery and previous chemotherapy, are factors that might impact on the risk for ARSR
together with patient-related factors such as body mass index (BMI), smoking status and
previous skin damage (Porock et al., 1998; Wells et al., 2004). In a pilot study (n=93) of
the frequency of ARSR in patients with breast cancer who underwent adjuvant RT it was shown
that 93% developed ARSR, mostly mild reactions. Patients reported low scores on pain and
itching (Sharp et al., 2011). Over 80% of the patients reported adherence to the skin care
recommendations which included application of a thin layer of Essex® cream, a non-perfumed
aqueous cream, on the irradiated area at least two times a day (Sharp et al., 2011). The
effects of skin care products containing Calendula Officinalis (marigold plant) on ARSR in
patients with breast cancer were investigated in a randomized clinical trial (Pommier et
al., 2004). Patients in the experimental group, treated with calendula cream had a
statistically significant lower incidence of severe ARSR, pain and treatment interruptions
in comparison with the patients in the control group, treated with trolamine.
The purpose of this blinded, randomized clinical trial is to compare two topical agents,
Calendula Weleda® cream and Essex® cream, in terms of efficacy to reduce the risk of severe
acute radiation skin reactions (ARSR) in relation to adjuvant radiotherapy (RT) for breast
cancer.
Patients were instructed to apply a thin layer of the assigned cream twice a day, starting
at the onset of RT and continue until two weeks after termination, or until the ARSR is
healed. The application should include the whole treatment area including the armpit and
shoulder/back area in patients treated with modified radical mastectomy. Patients are also
advised to not apply the cream within two hours before the RT in order to avoid possible
build-up effect. Daily wash with perfume free soap and tap water are recommended and
patients are advised to refrain from use of other topical agents in the irradiated area.
The primary endpoint is the efficacy to reduce acute radiation skin reactions (ARSR),
assessed with the Radiation Therapy Oncology Group/The Organization for Research and
Treatment of Cancer Acute Radiation Morbidity Scoring Criteria (RTOG/EORTC scale) at
follow-up.
Secondary endpoints include patient reported outcome measures; Quality of Life Questionnaire
(QLQ-C30), Sleep disturbances (MOS-sleep questionnaire) and symptoms experienced from the
irradiated area (visual analogue scale). Patients' experiences and adherence to the topical
agents are also evaluated.
A total of 400 patients are required to detect a true absolute reduction in the proportion
of patients with ARSR, from 35% with standard treatment (Essex® cream) to 20% with the
experimental treatment (Calendula Weleda® cream), with a significance level of 5% a power of
90%. With this sample size, 95% confidence intervals for the difference in proportions are
estimated to be in the order of ±10%. Assuming a rate of 5% of non-responders, the target
size has been set to 420 patients.
| Status | Completed |
| Enrollment | 420 |
| Est. completion date | September 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - radically operated for breast cancer, - aged 18 years or older, - signed informed consent Exclusion Criteria: - previous radiation in the same area, - severe general health problems, - ECOG performance status > 3, - reduced cognitive ability, - allergy to marigold plant |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Department of Oncology, Karolinska University Hospital | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska University Hospital |
Sweden,
Sharp L, Finnilä K, Johansson H, Abrahamsson M, Hatschek T, Bergenmar M. No differences between Calendula cream and aqueous cream in the prevention of acute radiation skin reactions--results from a randomised blinded trial. Eur J Oncol Nurs. 2013 Aug;17(4 — View Citation
Sharp L, Johansson H, Hatschek T, Bergenmar M. Smoking as an independent risk factor for severe skin reactions due to adjuvant radiotherapy for breast cancer. Breast. 2013 Oct;22(5):634-8. doi: 10.1016/j.breast.2013.07.047. Epub 2013 Aug 13. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Impact of smoking habits on the intensity of the skin reaction | Collection of data on smoking habits and measurements of carbon monoxide in exhaled air | 8 weeks | No |
| Primary | Grade of skin reactions to radiotherapy | Skin reactions due to radiotherapy using RTOG scale | 8 weeks | No |
| Secondary | Quality of life in relation to skin reaction | Measurements of sleep disturbances acc. to the MOS-SLEEP scale and QoL acc. to EORTC QLQ-C30 | 8 weeks | No |