Clinical trial · Observational
Impact of Oral Versus Intravenous 5-FU-Based Adjuvant Regimens on Sleep Quality and Depression in Patients With Gastrointestinal Cancers
Evaluation of the Effects of Oral Versus Intravenous 5-FU-Based Adjuvant Chemotherapy Regimens on Sleep Quality and Depression in Patients Diagnosed With Non-Metastatic Gastrointestinal System Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Oral 5-FU Group
- description
- Patients receiving oral 5-FU-based adjuvant chemotherapy (e.g., capecitabine or CAPEOX) for non-metastatic gastrointestinal system cancers.
- label
- Intravenous 5-FU Group
- description
- Patients receiving intravenous 5-FU-based adjuvant chemotherapy (e.g., FOLFOX) for non-metastatic gastrointestinal system cancers.
Primary outcomes (1)
- measure
- Change in Sleep Quality Score (Pittsburgh Sleep Quality Index - PSQI)
- timeFrame
- Baseline, Day 45, Day 90
- description
- Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) at Sleep quality will be assessed using the full version of the Pittsburgh Sleep Quality Index (PSQI) at three time points: prior to chemotherapy initiation (baseline), at day forty-five, and at day ninety. The PSQI total score ranges from 0 to 21, with higher scores indicating worse sleep quality. A score \>5 is commonly used to define poor sleep quality. Changes over time within groups and differences between the oral 5-FU and intravenous 5-FU treatment groups will be analyzed.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available