Graham, P.H., Plant, N., Graham, J.L., Browne, L., Borg, M., Capp, A., . . . Zissiadis, Y. (2013). A paired, double-blind, randomized comparison of a moisturizing durable barrier cream to 10% glycerine cream in the prophylactic management of postmastectomy irradiation skin care: Trans Tasman Radiation Oncology Group (TROG) 04.01. International Journal of Radiation Oncology, Biology, Physics, 86, 45–50. 

DOI Link

Study Purpose

A previous unblinded study demonstrated that an alcohol-free barrier film containing an acrylate terpolymer (ATP) was effective in reducing skin reactions compared with a 10% glycerine (sorbolene) cream. The different appearances of these products precluded a blinded comparison. To test the ATP principle in a double-blind manner required use of an alternative cream formulation, a moisturizing durable barrier cream (MDBC). This study tested the hypothesis that an ATP alcohol-free barrier film reduces the degree of radiation skin reaction compared with the 10% glycerine cream most commonly used for this purpose in women receiving postmastectomy radiation therapy in Australia.

Intervention Characteristics/Basic Study Process

The chest wall was divided into medial and lateral compartments, and patients were randomized to receive MDBC applied daily to the medial or lateral side and sorbolene to the other side. Patients were instructed to apply the separate creams daily at the start of radiation to each half of the area on the chest wall receiving radiation therapy and to continue until two weeks after radiation completion. Weekly observations, photographs, and symptom scores (pain and pruritus) were collected until week 12, or resolution of skin reactions if earlier. Skin dose was confirmed by centrally calibrated thermoluminescent dosimeters (TLDs).

Sample Characteristics

  • N = 318
  • AGE = 26–89 years
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients receiving radiation of at least 45 Gy in 25 fractions after total mastectomy
  • OTHER KEY SAMPLE CHARACTERISTICS: Aged 18 years or older, Eastern Cooperative Oncology Group performance status 0–2, ability to consent, ability to attend weekly for up to six weeks after treatment completion. Ineligibility: previous radiation therapy to chest wall, clinically evident cutaneous involvement by malignancy, pregnancy, known allergy to skin  care products

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Not specified  
  • LOCATION: 12 radiation treatment centers in Australia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care 

Study Design

  • Paired, double-blind, randomized comparison

Measurement Instruments/Methods

  • TLD measurements were performed twice during radiation with two TLDs per skin compartment. TLDs were centrally calibrated.
  • Patient outcomes were scored weekly using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scores.
  • Photographic audit of skin scores confirmed the pattern of reactions scored by clinicians.

Results

Rates of medial and lateral compartment skin reactions grade 3 or above were 23% and 41%, respectively. Rates by skin care products were identical at 32%. There was no significant difference between MDBC and sorbolene in the primary endpoint of peak skin reactions or secondary endpoints of area-under-curve (AUC) skin reaction scores.
 
Unpaired results: Skin reactions differed more by compartment than by product and were worse in the lateral compartment.  
 
Paired results for dichotomous skin reactions grade 3 and above: AUC scores showed no significant difference between treatment groups. 
 
Patient symptomatic skin scores: Greater pruritus was seen in the medial compartment, and greater pain symptoms were seen in the lateral compartment of the chest wall, but there was no significant difference by product. 
 
There was no difference in measured skin dose by treatment product, but lateral compartment doses were higher. Measured skin doses were higher in areas that developed grade 3–4 skin reaction versus those in grade 1–2 areas (P = .001).  

Conclusions

The MDBC did not reduce peak skin reaction compared to sorbolene. It is possible that this is related to the difference in formulation of the cream compared with film formulation.

Limitations

  • There was no clear consistency on how the cream should be used. Even though it was recommended for daily use, some patients did use it twice a day.

Nursing Implications

This study emphasizes the requirement for well-designed, appropriately powered, and controlled studies for skin care products. This study also potentially emphasizes that skin care products can vary in effectiveness based on formulation.