Quality of Life During Neoadjuvant Chemotherapy of Breast Cancer

• Conditions: C50; Malignant neoplasm of breast

• Registration Number: DRKS00016761
• Lead Sponsor: Gesellschaft für Klinische Forschung e.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-06
• Study Completion: 2021-06-02
• Results First Posted: 2023-11-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 54

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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MFI questionnaire Multidimensional Fatigue Inventory at each chemotherapy cycle<br>FACT-B questionnaire Functional Assessment of Cancer Therapy - Breast Cancer at each chemotherapy cycle

Secondary Outcome Measures

Name	Time	Method
- SFQ questionaire short fatigue questionnaire<br>- Frequency of premature chemotherapy termination <br>- Frequency of delays or dose reductions of the chemotherapy<br>- Incidence and severity of adverse drug reactions of the neo-adjuvant chemotherapy by specific questions and including neutropenia<br>