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Prevention of pruritus in patients with advanced colorectal cancer treated with mFOLFOX6 in combination with cetuximab as first-line therapy: A multi-center, prospective, observational cohort study

Prevention of pruritus in patients with advanced colorectal cancer treated with mFOLFOX6 in combination with cetuximab as first-line therapy: A multi-center, prospective, observational cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400080448
Enrollment
Unknown
Registered
2024-01-30
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

colorectal cancer

Interventions

Aprepitant cohort (Administer a triple antiemetic regimen of aprepitant injection, ondansetron, and dexamethasone):None
Non-aprepitant cohort (Administer a dual antiemetic regimen of ondansetron, and dexamethasone):None

Sponsors

The First Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1)=18 years old; (2)Histologically confirmed as colorectal cancer; (3)The patients are preparing to receive the first-line mFOLFOX6 regimen combined with cetuximab biweekly; (4)Patients receive a triple or dual regimen for the prevention of chemotherapy related nausea and vomiting; (5)The patient/family member signed an informed consent form and voluntarily participated in this study.

Exclusion criteria

Exclusion criteria: (1)Receive NK-1 receptor antagonist one week before enrollment; (2)Oral antifungal medication 4 weeks before enrollment or topical antifungal medication 2 weeks before enrollment; (3)The patients have a skin infection or dermatitis; (4)Patients who are allergic to any medication used in this study; (5)Using drugs that are prohibited from being used in combination with aprepitant; (6)Patients who are currently or plan to participate in other clinical studies; (7)Researchers determine other situations that are not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
The incidence of pruritus;

Secondary

MeasureTime frame
Time and severity of pruritus;The incidence, timing, and severity of rash;Safety of medication;quality of life of the patients;

Countries

China

Contacts

Public ContactQingwei Zhao

The First Affiliated Hospital, Zhejiang University School of Medicine

qwzhao@zju.edu.cn+86 571 8723 6339

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026