Prospective non-interventional study of tumor-associated fatigue syndrome under Anthracyclintherapie - Face -E (pirubicin)
- Conditions
- Fatigue, tumor asscociated
- Registration Number
- DRKS00007953
- Lead Sponsor
- IV Pharma GmbH
- Brief Summary
Background: Tumor patients often suffer from symptoms of fatigue, which can occur due to tumor or therapy and is manifested by extreme fatigue and exhaustion that often extends beyond the therapy and immensely limits the quality of life as well as the physical, psychological and cognitive performance of the patients and is emotionally very stressful for the affected persons and their families. Results: This was a non-interventional prospective observational single-arm cohort study of treatment with epirubicin LIV Pharma with parallel patient survey (DRKS-ID: DRKS00007953). During the documentation period, which lasted up to two years depending on the therapy regimen, parameters regarding the underlying oncological disease and its therapy were collected at regular intervals. At the same time, patients were asked about fatigue symptoms (Fatigue Scale MFI 20), quality of life (FACT-G) and their physical activity (BSA questionnaire according to Fuchs), as there are correlations between these patient-reported outcomes. Forty-seven patients were included in the study. Due to death and loss of contact, 3 of these patients dropped out of the population. Further documentation could not be used for the analysis due to missing patient questionnaires and incomplete documentation. Conclusion: An evaluation of the study is statistically not possible due to the low number of evaluable documentations. The incomplete response of the patient questionnaires can mainly be attributed to a lack of compliance, which can hardly be counteracted in a non-interventional study. It seems reasonable to investigate the tumor-associated fatigue syndrome within a registry study in order to reach the statistically necessary number of cases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 37
Histologically or cytologically confirmed tumor diseases of the female breast or ovaries for which Epirubicin LIV Pharma is approved as a drug according to the specialist information
- Age: older than 18 years
- Epirubicin LIV Pharma is used in therapy.
- A hand-dated and signed consent is available.
- The therapy was selected independently of a possible study inclusion.
- Contraindications to the use of Epirubicin LIV Pharma according to the SmPC.
- The current therapy was started more than 12 weeks ago.
- The patient is participating in a clinical trial at the same time.
- Pregnancy is present or the patient is breastfeeding.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy and Tolerability routine practice. Observational, non-interventional study.
- Secondary Outcome Measures
Name Time Method Side effects which were not observed so far.