Impact of Oral Versus Intravenous 5-FU-Based Adjuvant Regimens on Sleep Quality and Depression in Patients With Gastrointestinal Cancers

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 sleep quality and depression levels in patients with non-metastatic gastrointestinal system (GIS) cancers. Eligible adult patients (aged 18 years or older) who are scheduled to receive adjuvant chemotherapy at the Ankara Etlik City Hospital Medical Oncology Department will be assessed using the Pittsburgh Sleep Quality Index (PSQI) and the Beck Depression Inventory (BDI). These evaluations will be conducted at baseline (prior to chemotherapy), on day forty-five, and on day ninety of treatment. This study will not interfere with standard oncologic care. Instead, sleep disturbances and depressive symptoms will be monitored during routine clinical follow-up. Patients identified with significant psychological distress will be referred to psychiatry or sleep medicine departments for further evaluation. The results of this study may provide insights into how different routes of 5-FU administration impact patients' mental health and quality of life, potentially informing future supportive care strategies during adjuvant chemotherapy.

Eligibility

Inclusion Criteria:

* 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 Criteria:

* 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

Conditions3

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