Using Zinc and Clobetasol to Prevent Skin Reactions from Regorafenib

Impact of Zinc Supplementation and Transdermal Clobetasol in the Prophylaxis of Regorafenib-Induced Hand-Foot Skin Reaction: A Prospective Non-Randomized Study

This study is testing if taking zinc and using clobetasol cream can help prevent skin problems in people with solid tumors who are starting treatment with regorafenib for the first time.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Gazi University (other)
• Locations: 13 sites (Konya, Meram and 12 other locations)
• Trial ID: NCT06856590 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a combination of oral zinc supplementation and transdermal clobetasol cream in preventing and reducing the severity of hand-foot skin reactions (HFSR) caused by regorafenib treatment. It involves approximately 120 patients with solid tumors who are starting regorafenib for the first time. Participants will be assigned to one of three treatment groups: zinc and clobetasol, clobetasol alone, or zinc alone. The study will assess treatment effectiveness using established grading scales for HFSR.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed solid tumors starting regorafenib treatment for the first time and no prior hand-foot skin reactions.

Not a fit: Patients with pre-existing dermatologic conditions affecting the hands or feet, or those who have experienced prior skin reactions from similar therapies, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence and severity of skin reactions in patients undergoing regorafenib treatment, improving their quality of life and treatment adherence.

How similar studies have performed: While the use of clobetasol for skin reactions has shown promise, the combination with zinc supplementation is a novel approach that has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years
* Histologically confirmed solid tumor for which regorafenib is an approved treatment (e.g., metastatic colorectal cancer, gastrointestinal stromal tumor, hepatocellular carcinoma, glioblastoma, or others)
* Initiating regorafenib treatment for the first time
* ECOG performance status of 0-2
* Baseline hand-foot skin reaction (HFSR) of Grade 0 (no prior HFSR symptoms) according to CTCAE v5.0
* Adequate organ function, including:

AST/ALT ≤ 3× upper limit of normal (ULN) Creatinine clearance \> 50 mL/min Hemoglobin ≥ 9 g/dL Platelet count ≥ 75,000/mm³

* Able to tolerate oral zinc supplementation and/or topical corticosteroids
* Willing to participate and provide informed consent

Exclusion Criteria:

* Pre-existing dermatologic conditions affecting the hands or feet (e.g., psoriasis, eczema, active infections)
* Prior Grade ≥1 HFSR from any VEGFR-TKI therapy
* Allergy or known hypersensitivity to zinc, clobetasol, or other study components

Where this trial is running

Konya, Meram and 12 other locations

• Necmettin Erbakan University Meram Faculty of Medicine Hospital — Konya, Meram, Turkey (RECRUITING)
• Bursa Uludağ University Hospital — Bursa, Nilüfer, Turkey (RECRUITING)
• Karadeniz Technical University Hospital — Trabzon, Ortahisar, Turkey (RECRUITING)
• Sakarya University Hospital — Sakarya, Serdivan, Turkey (RECRUITING)
• Ankara Etlik City Hospital — Ankara, Yenimahalle, Turkey (RECRUITING)
• Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital — Ankara, Yenimahalle, Turkey (RECRUITING)
• Gazi University — Ankara, Yenimahalle, Turkey (RECRUITING)
• Afyonkarahisar University of Health Sciences Hospital — Afyonkarahisar, Turkey (RECRUITING)
• Ankara University Faculty of Medicine Hospital — Ankara, Turkey (NOT_YET_RECRUITING)
• Hacettepe University Faculty of Medicine Hospital — Ankara, Turkey (NOT_YET_RECRUITING)
• Dicle University Hospital — Diyarbakır, Turkey (RECRUITING)
• Tekirdağ Namık Kemal University Hospital — Tekirdag, Turkey (RECRUITING)
• Van Yüzüncü Yıl University Dursun Odabaş Hospital — Van, Turkey (RECRUITING)

Study contacts

• Study coordinator: Orhun Akdogan, MD

Conditions: Hand-Foot Skin Reaction, Regorafenib-Induced Skin Toxicity, Clobetasol, Zinc Supplementation, Metastatic Colorectal Cancer, Gastrointestinal Stromal Tumor, Hepatocellular Carcinoma