RecruitingNCT06996483

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


Sponsor

Ankara Etlik City Hospital

Enrollment

82 participants

Start Date

Jun 5, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares the effects of two forms of the same chemotherapy drug (5-FU) — taken as a pill versus given through a vein — on sleep quality and depression in patients with gastrointestinal cancers (such as colorectal or stomach cancer) receiving chemotherapy after surgery. **You may be eligible if...** - You are 18 or older with a confirmed non-metastatic gastrointestinal cancer (e.g., colorectal or stomach) - You are scheduled to receive 5-FU-based chemotherapy after surgery - You are in reasonably good physical condition (ECOG 0–2) - You have provided written informed consent **You may NOT be eligible if...** - You have a pre-existing psychiatric condition affecting sleep or mood - You are already receiving treatment for a sleep disorder or depression - You received chemotherapy or radiation therapy before your surgery for this diagnosis - You cannot understand or complete questionnaires due to language or cognitive barriers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Etlik City Hospital, Medical Oncology Department

Ankara, Yenimahalle, Turkey (Türkiye)

Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

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NCT06996483


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