Prospective Assessment of Quality of Life in Patients With Locally Recurrent Breast Cancer and Hyperthermic Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospektive Erfassung Der Lebensqualität Bei Patientinnen Mit Lokal Rezidiviertem Mammakarzinom Und Hyperthermer Radiotherapie (UKT HT03.1)
Overview
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.
Primary outcome measures
- 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.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Hospital Tübingen, Department of Radiation Oncology — Tübingen
Identifiers
NCT: NCT04878666 · UKT HT03_1