Clinical trial · Observational
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)
NCT04878666CI-TRIAL-00051675UKT HT03_1recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.