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ZINCLO-HAND: Zinc and Clobetasol for the Prevention of Regorafenib-Induced Hand-Foot Skin Reaction

NCT06856590 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-15

No results posted yet for this study

Summary

This study aims to evaluate whether a combination of oral zinc supplementation and transdermal clobetasol cream is effective in preventing and reducing the severity of hand-foot skin reaction (HFSR) induced by regorafenib treatment.

HFSR is one of the most common adverse effects of regorafenib, affecting more than 50% of patients, with 10-15% experiencing severe Grade 3 toxicity. Clobetasol, a high-potency corticosteroid, has been shown to significantly reduce the severity of HFSR when used preemptively rather than reactively. Additionally, recent clinical trials indicate that oral zinc supplementation may further reduce the incidence of Grade ≥2 HFSR.

This prospective, non-randomized interventional study will compare three treatment groups:

Oral zinc supplementation + transdermal clobetasol cream Transdermal clobetasol cream alone Oral zinc supplementation alone The study will assess the effectiveness of these treatments using CTCAE grading, the Hand-Foot Syndrome Scale-14, and quality of life measures (FACT-G, fatigue, and anxiety/depression scales). Additionally, the study will evaluate the impact of HFSR on treatment adherence, regorafenib dose modifications, and overall survival.

The study will enroll approximately 120 patients across multiple centers in Türkiye.

Conditions

  • Hand-Foot Skin Reaction (HFSR)

Interventions

DIETARY_SUPPLEMENT

Zinc Supplementation

Participants assigned to zinc-containing arms will receive oral zinc gluconate supplementation (78 mg twice daily) for 8 weeks. This intervention aims to evaluate the effect of zinc in preventing and reducing the severity of regorafenib-induced hand-foot skin reaction (HFSR).

DRUG

Clobetasol Propionate 0.05% Cream

Participants assigned to clobetasol-containing arms will receive topical clobetasol propionate 0.05% cream, applied twice daily to the palms and soles for 8 weeks. This intervention aims to assess the efficacy of clobetasol in preventing regorafenib-induced HFSR.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Principal Investigators

  • Ozan Yazıcı, Prof. · Gazi University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2025-09-01
Completion
2025-09-07

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06856590 on ClinicalTrials.gov