Impact of Oral Versus Intravenous 5-FU-Based Adjuvant Regimens on Sleep Quality and Depression in Patients With Gastrointestinal Cancers
NCT ID: NCT06996483
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
82 participants
OBSERVATIONAL
2025-06-05
2026-01-30
Brief Summary
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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.
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Detailed Description
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The study will be conducted at the Ankara Etlik City Hospital, Medical Oncology Department. A total of 100 adult patients (≥18 years) who are initiating adjuvant chemotherapy including 5-FU (either oral or IV formulation) for histopathologically confirmed non-metastatic GIS cancers will be included.
Eligible patients will be enrolled after providing informed consent. The Pittsburgh Sleep Quality Index (PSQI) and Beck Depression Inventory (BDI), both of which have been validated in Turkish, will be used to assess sleep quality and depression severity. These measurements will be obtained at three time points: (1) baseline (prior to chemotherapy initiation), (2) day 45, and (3) day 90 of treatment.
The study aims to detect early psychosocial changes that may occur during chemotherapy, particularly those related to sleep and mood. No changes or interventions will be made to the patients' standard oncological treatment. Patients showing severe sleep disturbances or depressive symptoms during follow-up will be referred to the relevant departments (psychiatry or sleep medicine) for further evaluation and care.
The goal of the study is to better understand how the route of 5-FU administration (oral vs. IV) influences sleep patterns and emotional well-being during adjuvant chemotherapy. This could help optimize supportive care strategies and improve the quality of life of patients undergoing treatment for GIS cancers.
Data will be analyzed using appropriate statistical tests. Categorical variables will be compared using Chi-square or Fisher's exact test; continuous variables will be compared using Student's t-test or Mann-Whitney U test, depending on distribution. A p-value of \<0.05 will be considered statistically significant.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Oral 5-FU Group
Patients receiving oral 5-FU-based adjuvant chemotherapy (e.g., capecitabine or CAPEOX) for non-metastatic gastrointestinal system cancers.
No interventions assigned to this group
Intravenous 5-FU Group
Patients receiving intravenous 5-FU-based adjuvant chemotherapy (e.g., FOLFOX) for non-metastatic gastrointestinal system cancers.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ankara Etlik City Hospital
OTHER_GOV
Responsible Party
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Galip Can Uyar
Medical Oncology, MD
Principal Investigators
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Dr. Osman Sütcüoğlu, MD
Role: STUDY_DIRECTOR
Etlik City Hospital, Medical Oncology Department
Locations
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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)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AESH-EK1-2023-775
Identifier Type: -
Identifier Source: org_study_id
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