Management of mild hand-foot syndrome associated with medical cancer therapies with an alcohol-free moisturizing and reparative gel containing omental lipids, urea, bromelain, and carnosine: a pilot prospective 12-week study

Hand-foot syndrome (HFS), also known as palmoplantar erythrodysesthesia, is a frequent and burdensome complication of several anticancer chemotherapies, negatively affecting patients’ quality of life. Depending on the treatment regimen, HFS may occur in 5-89% of patients. Currently, no standard therapies are available for its management. A recently commercialized alcohol-free gel containing emollient and skin-reparative components (omental purified lipids, urea, carnosine, and bromelain; POL-Podactive gel (POL-PA; Cantabria Labs, Caronno Pertusella, Italy) has shown efficacy in treating moderate-to-severe foot xerosis. However, no data are available regarding its potential role in the management of early-stage HFS. The aim of this study was to evaluate, in a pilot open trial, the efficacy and tolerability of POL-PA gel in patients with grade 1 HFS. Twelve patients (2 men and 10 women; mean age 58 years) with grade 1 HFS induced by anticancer treatments (mainly taxanes or antimetabolites) were enrolled in a 12-week pilot study after providing written informed consent. At baseline, all participants presented mild palmoplantar erythrodysesthesia and moderate xerosis. The gel was applied twice daily to the affected areas (hands and feet), with an average daily dose of 12 fingertip units (FTU; 6 g). Efficacy endpoints included the 10-item Dermatology Life Quality Index (DLQI) and subjective pain/dysesthesia assessed using a 10-cm Visual Analogue Scale (VAS; 0 = no pain, 10 = extreme pain). Assessments were performed at baseline, week 6, and week 12. The Common Terminology Criteria for Adverse Events (CTCAE) grade was also recorded at each visit. All patients completed the 12-week study. Mean DLQI decreased from 12±6 at baseline to 8±6 at week 6 and 6±5 at week 12 (p<0.02; Wilcoxon signed-rank test). Mean VAS score improved from 5±3 at baseline to 3.7±2 at week 6 and 3.0±2 at week 12, representing a 40% reduction (p<0.0016). No worsening of CTCAE grade was observed during the study. In this pilot study, an alcohol-free gel containing emollient and reparative components demonstrated beneficial effects on pain/dysesthesia and quality of life in patients with chemotherapy-induced grade 1 HFS. Controlled, well-designed trials are warranted to further define its therapeutic potential in this clinical setting.