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Prospective assessment of Quality of Life in patients with locally recurrent breast cancer after close R0, R1 or R2 resection or local inoperability and hyperthermic radiotherapy.
This prospective monocentric trial evaluates the health-related Quality of Life in patients with local recurrence of Breast cancer after close R0, R1 or R2 resection or local inoperability during and after radiotherapy in combination with hyperthermia of the chest wall. The Health-related Quality of Life and the intensity of fatigue will be documented by the EORTC QLQ-C30, EORTC QLQ - BR 23, FACT - B + 4 and FACIT - Fatigue Questionnaires at the end of the hypertermic radiotherapy and during follow-up after 3 and 12 month and then annually up to year 5.
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the health-related Quality of Life (QoL) during and after hyperthermic radiotherapy. QoL will be measured by the EORTC QLQ BR 23 | Assessment of the health-related QoL in patients who receive a surface hyperthermia in parallel with a radiotherapy of the chest wall as part of a multimodal therapy. This endpoint will be evaluated by the -BR 23 subscale (4 functional subscales, 4 symptom subscales.All subscales have a point value range from 0 to 100 points. A higher score represents better function and a higher quality of life. With symptom subscales, however, a higher score represents a higher level of symptoms or problems. | During hyperthermic radiotherapy up to five years of follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a histologically confirmed local recurrence of breast cancer after close R0, R1 or R2 resection respectively inoperable recurrence of the chest wall with or without a previous irradiation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanessa Heinrich, MD | Contact | +49 (0) 7071 29- | 82165 | vanessa.heinrich@med.uni-tuebingen.de |
| Daniel Zips, MD, Prof. | Contact | +49 (0) 7071 29- | 82165 | ro-info@med.uni-tuebingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Vanessa Heinrich, MD | University Hospital Tübingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tübingen, Department of Radiation Oncology | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |