Prospective Assessment of Quality of Life in Patients With Locally Recurrent Breast Cancer and Hyperthermic Radiotherapy (UKT HT03_1)

University Hospital Tuebingen

Status: Enrolling

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04878666

UKT HT03_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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