Clinical trial NCT04878666: Prospective Assessment of Quality of Life in Patients With Locally Recurrent Breast Cancer and Hyperthermic Radiotherapy
Official title: Prospektive Erfassung Der Lebensqualität Bei Patientinnen Mit Lokal Rezidiviertem Mammakarzinom Und Hyperthermer Radiotherapie (UKT HT03.1)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Hyperthermic Radiotherapy
Quality of Life
locally recurrent Breast Cancer
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the health-related Quality of Life (QoL) during and after hyperthermic radiotherapy. QoL will be measured by the EORTC QLQ BR 23
timeFrame: During hyperthermic radiotherapy up to five years of follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen, Department of Radiation Oncology
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Tübingen
name: Vanessa Heinrich, MD
role: PRINCIPAL_INVESTIGATOR
References: