A randomized multicenter phase II trial on the efficacy of a hydrocolloid dressing containing ceramide with a low-friction external surface for hand-foot skin reaction caused by sorafenib in patients with renal cell carcinoma.

Abstract

BACKGROUND:

The purpose of this study was to investigate the usefulness of a hydrocolloid dressing containing ceramide for hand-foot skin reaction (HFSR) on the soles of the feet in metastatic renal cell carcinoma (RCC) patients treated with sorafenib.

PATIENTS AND METHODS:

Patients with grade 1 HFSR on the soles of the feet were randomly assigned in to two groups. One group received a hydrocolloid dressing containing ceramide (arm A) and the other received 10% urea cream (arm B). Patients in both groups applied treatment to the affected sites on the soles of the feet, but not to the hands. The primary end point was the incidence of grade 2 or 3 HFSR on the soles of the feet in the first 4 weeks.

RESULTS:

Thirty-three patients were assessed (17 in arm A and 16 in arm B), and there were no significant differences in baseline characteristics between the two groups. During the observation period of this study, grade 2 or 3 HFSR on the soles of the feet was found in 29% of patients in arm A and was significantly less than the 69% in arm B (P=0.03). The incidence of HFSR on the hands, however, was similar in both arms. The median time to grade 2 or 3 HFSR on the soles of the feet was also significantly longer in arm A than in arm B (P=0.03).

CONCLUSIONS:

These results indicate that a hydrocolloid dressing containing ceramide prevented the worsening of HFSR caused by sorafenib in metastatic RCC patients.

CLINICAL TRIAL REGISTRATION NUMBER:

UMIN000002016.

• Authors: N Shinohara, N Nonomura, M Eto, G Kimura, H Minami, S Tokunaga, S Naito
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 25 Issue 2 Pg. 472-6 (Feb 2014) ISSN: 1569-8041 [Electronic] England
• PMID: 24351402 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antineoplastic Agents
• Ceramides
• Phenylurea Compounds
• Niacinamide
• Sorafenib

Topics

• Aged
• Antineoplastic Agents (adverse effects, therapeutic use)
• Bandages, Hydrocolloid
• Carcinoma, Renal Cell (drug therapy, secondary)
• Ceramides (administration & dosage)
• Female
• Hand-Foot Syndrome (therapy)
• Humans
• Kaplan-Meier Estimate
• Kidney Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Niacinamide (adverse effects, analogs & derivatives, therapeutic use)
• Phenylurea Compounds (adverse effects, therapeutic use)
• Sorafenib
• Surface Properties
• Treatment Outcome