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Outcome Measures

Primary Outcomes (1)

Incidence and Severity of Hand-Foot Skin Reaction (HFSR) at Week 8
The incidence and severity of hand-foot skin reaction (HFSR) will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The proportion of patients experiencing Grade ≥2 HFSR will be compared between the intervention groups to evaluate the efficacy of zinc supplementation and/or clobetasol in preventing HFSR.
8 weeks

Secondary Outcomes (5)

Duration of Hand-Foot Skin Reaction (HFSR)
8 weeks
Regorafenib Dose Modifications Due to HFSR
8 weeks
Quality of Life (FACT-G Score Change)
Baseline and 8 weeks
Progression-Free Survival (PFS) in Patients with and without Severe HFSR
Up to 6 months
Overall Survival (OS) in Patients with and without Severe HFSR
6 months

Study Arms (3)

Zinc + Clobetasol Group

EXPERIMENTAL

Participants in this group will receive oral zinc supplementation (78 mg zinc gluconate twice daily) combined with topical clobetasol propionate 0.05% cream, applied twice daily to the palms and soles for 8 weeks. This group aims to evaluate the combined efficacy of zinc and clobetasol in preventing regorafenib-induced hand-foot skin reaction (HFSR).

Dietary Supplement: Zinc SupplementationDrug: Clobetasol Propionate 0.05% Cream

Clobetasol Alone Group

EXPERIMENTAL

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

Drug: Clobetasol Propionate 0.05% Cream

Interventions

Zinc SupplementationDietary supplement

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).

Zinc + Clobetasol GroupZinc Alone

Clobetasol Propionate 0.05% CreamDrug

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.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

Study Sites (13)

Necmettin Erbakan University Meram Faculty of Medicine Hospital

Konya, Meram, 42080, Turkey (Türkiye)

Bursa Uludağ University Hospital

Bursa, Nilüfer, 16059, Turkey (Türkiye)

Karadeniz Technical University Hospital

Trabzon, Ortahisar, 61080, Turkey (Türkiye)

Sakarya University Hospital

Sakarya, Serdivan, 54050, Turkey (Türkiye)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Gazi University

MeSH Terms

Conditions

Colorectal NeoplasmsGastrointestinal Stromal TumorsCarcinoma, Hepatocellular

Interventions

Clobetasol

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type

interventional

Phase

not applicable

Allocation

NON RANDOMIZED

Masking

NONE

Purpose

PREVENTION

Intervention Model

PARALLEL

Model Details: This study follows a parallel assignment model, where participants are assigned to one of three intervention groups based on the treating physician's decision. Each group receives a different preventive approach for regorafenib-induced hand-foot skin reaction (HFSR): 1. Oral zinc supplementation + transdermal clobetasol cream 2. Transdermal clobetasol cream alone 3. Oral zinc supplementation alone Participants will remain in their assigned groups throughout the study period, and no crossover between groups will occur. The study aims to compare the efficacy of these interventions in preventing and reducing the severity of HFSR.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

Zinc + Clobetasol Group

Clobetasol Alone Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Zinc Alone

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

Zinc + Clobetasol Group

Clobetasol Alone Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Zinc Alone

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations