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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04878666

Acronym

UKT HT03_1

Enrollment

Registered

2021-05-07

Start date

2020-08-01

Completion date

2026-12-31

Last updated

2021-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Hyperthermic Radiotherapy, Quality of Life, locally recurrent Breast Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the health-related Quality of Life (QoL) during and after hyperthermic radiotherapy. QoL will be measured by the EORTC QLQ BR 23	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.

Countries

Germany

Contacts

Primary ContactVanessa Heinrich, MD

vanessa.heinrich@med.uni-tuebingen.de+49 (0) 7071 29-

Backup ContactDaniel Zips, MD, Prof.

ro-info@med.uni-tuebingen.de+49 (0) 7071 29-

Outcome results