Assessing Quality of Life in Patients with Locally Recurrent Breast Cancer Receiving Hyperthermic Radiotherapy
Prospektive Erfassung Der Lebensqualität Bei Patientinnen Mit Lokal Rezidiviertem Mammakarzinom Und Hyperthermer Radiotherapie (UKT HT03.1)
This study is testing how hyperthermic radiotherapy affects the quality of life and fatigue levels in patients with locally recurrent breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen, Baden-Wurttemberg) |
| Trial ID | NCT04878666 on ClinicalTrials.gov |
What this trial studies
This observational trial focuses on evaluating the health-related quality of life in patients with locally recurrent breast cancer who have undergone close resection or are locally inoperable. Participants will receive hyperthermic radiotherapy, and their quality of life and fatigue levels will be assessed using validated questionnaires at various intervals, including after treatment and during follow-up. The study aims to provide insights into the impact of this treatment approach on patients' well-being over time.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed local recurrence of breast cancer after close resection or inoperable recurrence.
Not a fit: Patients with extensive distant metastases, severe heart disease, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how hyperthermic radiotherapy affects the quality of life for patients with locally recurrent breast cancer.
How similar studies have performed: While there is ongoing research in hyperthermic radiotherapy, this specific approach focusing on quality of life in locally recurrent breast cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tübingen, Baden-Wurttemberg
- University Hospital Tübingen, Department of Radiation Oncology — Tübingen, Baden-Wurttemberg, Germany (Recruiting)
Study contacts
- Principal investigator: Vanessa Heinrich, MD — University Hospital Tübingen
- Study coordinator: Vanessa Heinrich, MD
- Email: vanessa.heinrich@med.uni-tuebingen.de
- Phone: +49 (0) 7071 29-
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.