Prospective Assessment of Quality of Life in Patients With Locally Recurrent Breast Cancer and Hyperthermic Radiotherapy

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT04878666

Studienbeginn:
August 2020

Letztes Update:
07.05.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Tuebingen

Collaborator:
-

Studienleiter

Vanessa Heinrich, MD
Principal Investigator
University Hospital Tübingen

Kontakt

Vanessa Heinrich, MD
Kontakt:
Phone: +49 (0) 7071 29-
Phone (ext.): 82165
E-Mail: vanessa.heinrich@med.uni-tuebingen.de» Kontaktdaten anzeigen

Daniel Zips, MD, Prof.
Kontakt:
Phone: +49 (0) 7071 29-
Phone (ext.): 82165
E-Mail: ro-info@med.uni-tuebingen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Tübingen, Department of Radiation Oncology
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Vanessa Heinrich, MD
Phone: +49 (0)7071 29-
Phone (ext.): 82165
E-Mail: Vanessa.heinrich@med.uni-tuebingen.de

Daniel Zips, MD, Prof.
Phone: +49 (0)7071 29-
Phone (ext.): 82165
E-Mail: ro-info@med.uni-tuebingen.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed local recurrence of breast cancer after close resection (≤1mm

Resection margin), R1 or R2 resection respectively inoperable recurrence of the chest

wall

- age ≥18 Jahre

- ECOG PS 0-2

- Estimated life expectancy more than 2 years

- Informed consent

Exclusion Criteria:

- Extensive distant metastases that have an estimated life expectancy of <2a

- Heart disease: severe heart failure (NHYA III / IV), coronary heart disease, state

after Myocardial infarction within the last 6 months), AV block III °

- Cardiac pacemaker

- Second malignancy (except cervical carcinomas in situ, local controlled basaliomas,

superficial bladder carcinomas (Ta, Tis, T1) or other carcinomas that have lasted more

than 5 years behind and have been treated curatively)

- Pregnancy or breastfeeding

- Implanted port on the side to be treated in the Hyperthermia field (located

contralateral is not an exclusion criteria)

- Subclavian vein thrombosis less than <6 months behind

- Other circumstances that preclude hyperthermia

- Circumstances that conflict with regular follow-up care

- Transplanted organs

- Other implants of the ipsilateral chest wall

Studien-Rationale

Primary outcome:

1. Evaluation of the health-related Quality of Life (QoL) during and after hyperthermic radiotherapy. QoL will be measured by the EORTC QLQ BR 23 (Time Frame - During hyperthermic radiotherapy up to five years of follow-up.):
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.

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Prospective Assessment of Quality of Life in Patients With Locally Recurrent Breast Cancer and Hyperthermic Radiotherapy"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!