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

NCT06996483 | Completed

• 1 other identifier: AESH-EK1-2023-775
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 3

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 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

Gastrointestinal Neoplasms

Keywords

Adjuvant Chemotherapy; 5-Fluorouracil; Sleep Quality; Depression; Gastrointestinal Cancer; Oral Chemotherapy; Intravenous Chemotherapy; Beck Depression Inventory; Pittsburgh Sleep Quality Index

Outcome Measures

Primary Outcomes (1)

• Change in Sleep Quality Score (Pittsburgh Sleep Quality Index - PSQI)

  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.

  Baseline, Day 45, Day 90

Secondary Outcomes (1)

• Change in Depression Score (Beck Depression Inventory - BDI)

  Baseline, Day 45, Day 90

Study Arms (2)

Oral 5-FU Group

Patients receiving oral 5-FU-based adjuvant chemotherapy (e.g., capecitabine or CAPEOX) for non-metastatic gastrointestinal system cancers.

Intravenous 5-FU Group

Patients receiving intravenous 5-FU-based adjuvant chemotherapy (e.g., FOLFOX) for non-metastatic gastrointestinal system cancers.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with non-metastatic gastrointestinal cancers who are receiving adjuvant chemotherapy with oral or intravenous 5-fluorouracil-based regimens at a tertiary cancer center.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (3)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06210, Turkey (Türkiye)

Location

Etlik City Hospital, Medical Oncology Department

Ankara, Yenimahalle, 06210, Turkey (Türkiye)

Location

Etlik City Hospital

Ankara, Yenimahalle, 06210, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Dr. Osman Sütcüoğlu, MD

  Etlik City Hospital, Medical Oncology Department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncology, MD

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: June 5, 2025
• Primary Completion: October 5, 2025
• Study Completion: April 26, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)