Status:
RECRUITING
Impact of Oral Versus Intravenous 5-FU-Based Adjuvant Regimens on Sleep Quality and Depression in Patients With Gastrointestinal Cancers
Lead Sponsor:
Ankara Etlik City Hospital
Conditions:
Gastrointestinal Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
This prospective, non-randomized, single-center observational study is designed to investigate the effects of oral versus intravenous (IV) 5-fluorouracil (5-FU)-based adjuvant chemotherapy regimens on...
Detailed Description
This is a prospective, non-randomized, single-center observational study designed to investigate the effects of oral versus intravenous (IV) 5-fluorouracil (5-FU)-based adjuvant chemotherapy regimens ...
Eligibility Criteria
Inclusion
- Histopathologically confirmed non-metastatic gastrointestinal system cancer (e.g., colorectal, gastric)
- Age ≥18 years
- Planned to receive adjuvant chemotherapy containing 5-FU (either oral or IV)
- ECOG performance status 0-2
- Provided informed consent
Exclusion
- Patients with psychiatric disorders affecting sleep or mood
- Receiving treatment for primary sleep disorders or depression
- Prior chemotherapy or radiotherapy for the current diagnosis
- Inability to complete the questionnaires due to cognitive or language barriers
Key Trial Info
Start Date :
June 5 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06996483
Start Date
June 5 2025
End Date
January 30 2026
Last Update
January 5 2026
Active Locations (3)
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1
Ankara Etlik City Hospital
Ankara, Yenimahalle, Turkey (Türkiye), 06210
2
Etlik City Hospital, Medical Oncology Department
Ankara, Yenimahalle, Turkey (Türkiye), 06210
3
Etlik City Hospital
Ankara, Yenimahalle, Turkey (Türkiye), 06210