Assessing Quality of Life in Patients with Locally Recurrent Breast Cancer Receiving Hyperthermic Radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Hospital Tübingen, Department of Radiation Oncology
  Tübingen, Baden-Wurttemberg, Germany Recruiting

Study contacts

• Principal investigator: Vanessa Heinrich, MD — University Hospital Tuebingen
• Study coordinator: Vanessa Heinrich, MD
• Email: vanessa.heinrich@med.uni-tuebingen.de
• Phone: +49 (0) 7071 29-

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.