Prospective Observational Study Assessing the Prophylactic Effect of Topical Diclofenac on Hand-Foot Syndrome in Patients With Colorectal and Gastric Cancer Receiving Capecitabine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 2
- 主要终点
- Incidence of grade ≥2 hand-foot syndrome (HFS)
研究概览
简要总结
Hand-foot syndrome (HFS) is a frequent adverse effect of capecitabine, presenting with redness, swelling, pain, and peeling of the skin on the palms and soles. These symptoms may impair daily activities and lead to treatment modifications.
This prospective observational study is being conducted at two tertiary oncology centers in Turkey to evaluate whether prophylactic use of topical diclofenac gel can prevent or delay the development of HFS in patients receiving capecitabine for colorectal or gastric cancer. Approximately 150 patients are enrolled and managed according to physician preference. Patients either receive topical diclofenac gel (applied twice daily to the hands and feet) or are followed with active monitoring.
The primary objective is to assess the incidence of grade 2 or 3 HFS. Secondary objectives include time to onset of HFS and the frequency of capecitabine dose reductions related to HFS.
详细描述
Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysesthesia, is a common dermatologic toxicity of fluoropyrimidine chemotherapy such as capecitabine. Clinically significant HFS (grade ≥2) can negatively impact treatment adherence and quality of life by necessitating dose interruptions or reductions. The underlying mechanisms are not fully understood, but inflammatory pathways, including cyclooxygenase-2 (COX-2) signaling, are thought to contribute.
Preventive strategies for HFS remain limited. Celecoxib, a systemic COX-2 inhibitor, has been shown to reduce HFS incidence but is not widely adopted due to safety concerns. Topical diclofenac gel, a locally acting nonsteroidal anti-inflammatory drug (NSAID), represents a potential low-toxicity prophylactic approach.
This prospective, multicenter observational study is designed to evaluate the prophylactic effect of topical diclofenac in patients with colorectal or gastric cancer initiating capecitabine therapy. The study is conducted at Gazi University Faculty of Medicine and Ankara Etlik City Hospital. Eligible participants are adults scheduled to receive capecitabine-based therapy who have not received prior chemotherapy.
Participants are managed according to physician preference:
Topical diclofenac group: Patients apply 1% topical diclofenac gel to clean, dry skin on the hands and feet twice daily during capecitabine treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of grade ≥2 hand-foot syndrome (HFS)
时间窗: Up to 24 weeks (from first capecitabine dose through study completion)
Proportion of participants who develop grade ≥2 HFS during capecitabine therapy. HFS will be assessed weekly by oncology clinicians using the Common Terminology Criteria for Adverse Events (CTCAE). Numerator: participants with grade ≥2 HFS; Denominator: all enrolled participants.
次要结局
- Time to onset of grade ≥2 hand-foot syndrome (HFS)(Up to 24 weeks (baseline to first event or end of study follow-up))
研究者
Orhun Akdoğan
Principal Investigator, Department of Medical Oncology, Gazi University Faculty of Medicine
Gazi University