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

Breast Cancer Clinical Trial

— UKT HT03_1  

Official title:

Prospektive Erfassung Der Lebensqualität Bei Patientinnen Mit Lokal Rezidiviertem Mammakarzinom Und Hyperthermer Radiotherapie (UKT HT03.1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04878666
• Other study ID #: UKT HT03_1
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2020
• Source: University Hospital Tuebingen
• Contact: Vanessa Heinrich, MD
• Phone: +49 (0) 7071 29-
• Email: vanessa.heinrich[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Germany	University Hospital Tübingen, Department of Radiation Oncology	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.