A Self-controlled Trial of Prophylactic Topical Application of Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial-

A Self-controlled Trial of Prophylactic Topical Application of Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial- - Vitamin K1 Cream for Cetuximab-related Skin Rash -VANQUISH trial-

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010280

Enrollment

Registered

2013-03-25

Start date

2013-03-25

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Colorectal Cancer

Interventions

Vitamin K1 cream Plcebo cream

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically comfirmed colorectal adenocarcinoma 2. Plannning to administer cetuximab containing chemotherapy 3. ECOG Performance Status(PS):0-2 4. Age >=20 5. Life expectation >=4wks 6.Written informed concent

Exclusion criteria

Exclusion criteria: 1. Grade1-3 cutaneous symptom of face 2. Continuous administration of steroid or antibiotics for whole-body or face 3. Administration of vitamin K or vitamin K antagonist 4. History of cetuximab containing chemotherapy 5. Physician's decision

Design outcomes

Primary

Measure	Time frame
The incidence of grade2-5 rash acneiform (CTCAE v4.0) of face whithin 4 weeks from starting cetuximab containing chemotherapy	—

Secondary

Measure	Time frame
-The safety of vitamin K1 cream -The incidence of grade2-3 rash acneiform (MASCC scale) of face whithin 4 weeks from starting cetuximab containing chemotherapy -The compliance of prophylactic treatment of vitamin K1 cream	—

Countries

Japan

Contacts

Public ContactKentaro Yamazaki

Shizuoka Cancer Center Gastrointestinal Oncology

k.yamazaki@scchr.jp055-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026