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

Launched by ANKARA ETLIK CITY HOSPITAL · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how different ways of taking a common chemotherapy drug called 5-fluorouracil (5-FU) affect sleep quality and feelings of depression in patients with non-metastatic gastrointestinal cancers, like colorectal or gastric cancer. The trial will include adults aged 18 and older who are set to receive this chemotherapy. Participants will complete simple questionnaires to assess their sleep and mood before starting treatment, and again at 45 and 90 days into their chemotherapy.

It's important to know that this study won't change how patients receive their regular treatment. Instead, it focuses on understanding how the method of taking the medication—either by mouth or through an IV—might impact their overall well-being. If any patient shows signs of significant distress, they will be referred to specialists for additional support. This research aims to help improve the quality of life for patients undergoing chemotherapy by identifying potential issues with sleep and mental health.

Gender

ALL

Eligibility criteria

• 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