Zenda, S., Ishi, S., Kawashima, M., Arahira, S., Tahara, M., Hayashi, R., . . . Ichihashi, T. (2013). A Dermatitis Control Program (DeCoP) for head and neck cancer patients receiving radiotherapy: A prospective phase II study. International Journal of Clinical Oncology, 18, 350–355. 

To clarify the benefit of using a dermatitis control program without using corticosteroids

Patients with head and neck cancer undergoing radiotherapy followed a three-step protocol using gentle washing alone (step one), moistened wound environment with Vaseline^® or dimethyl isopropyl-azulene (step two), or infection prevention with antibiotics (step three) for dermatitis grades 1, 2, and 3. Patients with grade 1–3 dermatitis all performed gentle washing. Patients with grade 2 dermatitis covered the radiated area with Vaseline gauze or dimethyl isopropyl-azulene, and patients with grade 3 dermatitis warranted antibiotics for infection.

• N = 113    
• MEDIAN AGE = 63 years
• AGE RANGE = 22–87 years
• MALES: 82% (93 patients), FEMALES: 18% (20 patients)
• KEY DISEASE CHARACTERISTICS: Patients with head and neck cancer (squamous cell carcinoma) aged 22–87 years undergoing radiation therapy (RT) (80 patients: RT as initial approach; 33 patients: postoperative RT)
• OTHER KEY SAMPLE CHARACTERISTICS: Median radiation dose was 70 Gy with a range of 54–70 Gy. Chemotherapy regimen: cisplatin alone in 53 patients; cisplatin plus 5-FU in 11 patients. Primary site was larynx: 33 patients; oropharynx: 23 patients; hypopharynx: 18 patients; tongue/oral cavity: 12 patients, and unknown primary site: 14 patients

• SITE: Single site  
• SETTING TYPE: Multiple settings  
• LOCATION: Outpatient and inpatient

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Adults

• Prospective phase II

• Descriptive statistics, statistical analysis with 90% power and one-sided type-I error 5%
• Physicians and nurses used Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 to grade dermatitis.

Following the dermatitis control program, grade 2 dermatitis was evident in 63 patients (56%), and grade 3 dermatitis was evident in 11 patients (less than 10%). There was no evidence of grade 4 dermatitis. Median time to onset of grade 2 dermatitis was 43.5 days. Seventy-one patients (63%) used step two or three for dermatitis during RT, and by two weeks after the completion of RT, 21 patients used step two or three. One month after RT completion, two patients were using step two or three for dermatitis. All patients were able to have their planned radiation without dose reduction. The rate of unplanned treatment breaks (10.6%) was low.

The dermatitis control protocol for patients with head and neck cancer undergoing RT described in this study was useful and effective at controlling severe radiodermatitis according to CTCAE version 3.0. Studies using larger numbers of patients and randomization could provide more evidence-based support for the use of a standardized protocol.

• Risk of bias (no random assignment)
• Risk of bias(sample characteristics)—only patients with squamous cell carcinoma of the head and neck were studied
• Other limitations/explanation: Without comparison with corticosteroids in the treatment protocol, there is no way to determine whether corticosteroids should or should not be used in preventing/treating radiation dermatitis. Dosing, route, and type of antibiotic regarding step three are not described. Further, the authors reported that a limitation of their study included that they could not mention the prevention of dermatitis.

A treatment program including gentle cleansing of the radiation field followed by moist, protective barriers (Vaseline gauze or dimethyl isopropyl-azulene), depending on the grade of dermatitis, could offer standardized care and better patient outcomes in terms of lessened skin irritation and fewer unplanned treatment breaks due to compromised skin integrity.