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A multicenter, randomized, double-blind, placebo-controlled clinical study on the prevention of EGFRI-induced dermal toxicity by Xiaozhenfang prescription

A multicenter, randomized, double-blind, placebo-controlled clinical study on the prevention of EGFRI-induced dermal toxicity by Xiaozhenfang prescription

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095160
Enrollment
Unknown
Registered
2025-01-02
Start date
2022-12-05
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFRI-induced dermal toxicity

Interventions

Experimental group :EGFRI combined with Xiaozhenfang granule
control group:EGFRI combined with Xiaozhenfang granule simulation agent

Sponsors

Jiangsu Province Hospital on Integration of Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the diagnostic criteria for NSCLC and have been treated with EGFRI (gefitinib, erlotinib, ectinib, afatinib, metrotinib, osititinib, ametinib, etc.) for EGFR mutations through pathological and genetic testing. (2) patients with unconsciousness disorder; (3) PS score 3 months; (4) Aged 18-85; (5) no serious damage to the heart, liver, kidney or hematopoietic system; (6) Participate in clinical research voluntarily and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Present rash of any grade; (2) Past receipt of EGFRI; (3) are receiving topical antibiotics, steroids or oral antibiotics, immunomodulators and other medications that may treat or prevent the rash; (4) Participate in any other clinical study; (5) Patients who cannot take oral medication; (6) Patients with mental illness who cannot cooperate; (7) Pregnant women.

Design outcomes

Primary

MeasureTime frame
NCI-CTCAE 5.0 Classification of adverse reactions;

Secondary

MeasureTime frame
EORTC QLQ-C30 Quality of Life score;Patient Anxiety and Depression Scale (HADS) score;EGFRI dose;Disease control rate, efficacy evaluation (RESIST 1.1);

Countries

China

Contacts

Public ContactXing Haiyan

Jiangsu Province Hospital on Integration of Chinese and Western Medicine

2057574584@qq.com+86 137 0145 5246

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 16, 2026