Trial document




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  DRKS00016761

Trial Description

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Title

Quality of Life During Neoadjuvant Chemotherapy of Breast Cancer

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Trial Acronym

QOLNEO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

To explore the course of cancer- and treatment-related fatigue and health-related quality of life during chemotherapy preceding tumour surgery in breast cancer patients

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Brief Summary in Scientific Language

Non-interventional study to explore the course of cancer- and treatment-related fatigue and health-related quality of life during neo-adjuvant chemotherapy of breast cancer patients

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Organizational Data

  •   DRKS00016761
  •   2019/05/06
  •   [---]*
  •   yes
  •   Approved
  •   195/19 s , Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   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 life using the MFI-questionnaire "Multidimensional Fatigue Inventory" and the FACT-B questionnaire "Functional Assessment of Cancer Therapy - Breast Cancer", respectively.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

MFI questionnaire "Multidimensional Fatigue Inventory" at each chemotherapy cycle
FACT-B questionnaire "Functional Assessment of Cancer Therapy - Breast Cancer" at each chemotherapy cycle

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2019/06/12
  •   50
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   80   Years
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Additional 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.

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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.

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Addresses

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    • Gesellschaft für Klinische Forschung e.V.
    • Mr.  PD Dr.  Stephan  Baumgartner 
    • Hardenbergstr. 20
    • 10623  Berlin
    • Germany
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    • Gesellschaft für Klinische Forschung e.V.
    • Mr.  Dr.  Marcus  Reif 
    • Hardenbergstr. 20
    • 10623  Berlin
    • Germany
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    • Gesellschaft für Klinische Forschung e.V.
    • Mr.  Dr.  Marcus  Reif 
    • Hardenbergstr. 20
    • 10623  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Gesellschaft für klinische Forschung e.V.
    • Mr.  PD Dr.  Stephan  Baumgartner 
    • Hardenbergstr. 20
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.