C50
Conditions
Interventions
Group 1: Female patients with malignant neoplasia of the breast are repeatedly asked over the course of neoadjuvant chemotherapy for their cancer-related fatigue and their health-related quality of li
Sponsors
Gesellschaft für Klinische Forschung e.V.
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed UICC-stage I-III (without T0, Tis, T1mic) invasive adenocarcinoma of the breast 2) Planned neo-adjuvant chemotherapy according to the guidelines. 3) Age: 18 to 80 years 4) Gender: female 5) Performance status: ECOG 0-2 6) Legal competence 7) Voluntarily given written informed consent in advance for this observation.
Exclusion criteria
Exclusion criteria: 1) Pregnancy 2) Clinically significant concomitant condition critically influencing the ability of the patient to follow the requirements of the clinical observation. 3) Use of any investigational agent or participation in a clinical trial currently or during the last 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MFI questionnaire "Multidimensional Fatigue Inventory" at each chemotherapy cycle FACT-B questionnaire "Functional Assessment of Cancer Therapy - Breast Cancer" at each chemotherapy cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| - SFQ questionaire "short fatigue questionnaire" - Frequency of premature chemotherapy termination - Frequency of delays or dose reductions of the chemotherapy - Incidence and severity of adverse drug reactions of the neo-adjuvant chemotherapy by specific questions and including neutropenia | — |
Countries
Germany
Contacts
Public ContactMarcus Reif
Gesellschaft für Klinische Forschung e.V.
Outcome results
None listed