Prospective Non-interventional Study of Tumor-associated Fatigue Syndrom under Taxane Therapy - FaTa-P(aclitaxel)
- Conditions
- Fatigue, cancer related
- Registration Number
- DRKS00006016
- Lead Sponsor
- IV Pharma GmbH
- Brief Summary
Background: Tumor patients often suffer from symptoms of fatigue, which can be tumor- or therapy-related and is manifested by extreme fatigue and exhaustion that often persists for a long time beyond the therapy, immensely limiting the quality of life as well as the physical, psychological and cognitive performance of the patients and being 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 paclitaxel LIV Pharma with concurrent patient survey (DRKS ID: DRKS00006016). 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 (EORTC QLQ-C30) and their physical activity (BSA questionnaire according to Fuchs), as there are correlations between these Patient Reported Outcomes. 267 patients were included in the study. Due to noncompliance with inclusion and exclusion criteria, death, loss of contact, and failure to initiate documentation, 71 of these patients dropped out of the population. Additional documentation could not be used for analysis due to missing patient questionnaires and documentation not being completed. Conclusion: An evaluation of the study is statistically not possible due to the small 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
- Complete
- Sex
- All
- Target Recruitment
- 267
Minimum Age 18 years
- Informed Consent
- Underlying Tumor disease of breast, lung or ovarian
- No pregnancy
- Therapy with Paclitaxel LIV Pharma
- The current therapy was started no more than 12 weeks ago
- No simultaneous, further study participation
- Contraindications to the use of oxaliplatin LIV Pharma according to the SmPC.
- The current therapy was started more than 12 weeks ago.
- The patient is participating in a study 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 Course of Fatiguesyndroms, assessed by MFI questionnaire (mulitdimensional fatigue inventory) at baseline, cycles 2, 4, 6, 8, 10, 12, end of treatment and follow-up visits 1-3 as well as BSA-Questionnaire on physical activity and sports activity assessed at cycles 1, 5 , 9, end of treatment and follow-up examinations 1-3
- Secondary Outcome Measures
Name Time Method Course the Quality of Life collected by questionnaire EORTC C30-v 3.0 at baseline, cycles 4, 8, 12, end of treatment and follow-up visits 1 -3