Status:
COMPLETED
Sleep Disorders Prior to and During a Course of Radiotherapy for Breast Cancer
Lead Sponsor:
University Hospital Schleswig-Holstein
Collaborating Sponsors:
Zealand University Hospital
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
The main goal of the study is to evaluate sleep disorders in breast cancer patients prior to and during a course of radiotherapy in terms of severity of sleep disorders, distress for the patients and ...
Detailed Description
The majority of breast cancer patients receive adjuvant radiotherapy, either following breast-conserving surgery or mastectomy. The situation that a patient needs to be irradiated may cause distress d...
Eligibility Criteria
Inclusion
- Female patient with histologically proven breast cancer
- Indication for radiotherapy
- Sleep disorders (i.e. at least 2 points on the sleep disorder self-rating scale)
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- Age ≥18 years
- Written informed consent
- Capacity of the patient to contract
Exclusion
- Pregnancy, Lactation
- Expected non-compliance (patient unable to use the seizure diary)
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04879264
Start Date
June 1 2021
End Date
December 5 2022
Last Update
January 15 2025
Active Locations (1)
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1
Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein
Lübeck, Germany, 23562