Prospective Assessment of Quality of Life in Patients With Locally Recurrent Breast Cancer and Hyperthermic Radiotherapy (UKT HT03_1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Vanessa Heinrich, MD; Phone Number: 82165 +49 (0) 7071 29-; Email: vanessa.heinrich@med.uni-tuebingen.de
• Study Contact Backup: Name: Daniel Zips, MD, Prof.; Phone Number: 82165 +49 (0) 7071 29-; Email: ro-info@med.uni-tuebingen.de

Study Locations

• Germany
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Recruiting
      • University Hospital Tübingen, Department of Radiation Oncology
      • Contact: Vanessa Heinrich, MD; Phone Number: 82165 +49 (0)7071 29-; Email: Vanessa.heinrich@med.uni-tuebingen.de
      • Contact: Daniel Zips, MD, Prof.; Phone Number: 82165 +49 (0)7071 29-; Email: ro-info@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with a histologically confirmed local recurrence of breast cancer after close R0, R1 or R2 resection respectively inoperable recurrence of the chest wall with or without a previous irradiation.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the health-related Quality of Life (QoL) during and after hyperthermic radiotherapy. QoL will be measured by the EORTC QLQ BR 23	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.	During hyperthermic radiotherapy up to five years of follow-up.

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Vanessa Heinrich, MD, University Hospital Tübingen

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Quality of Life; Hyperthermic Radiotherapy; locally recurrent Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: UKT HT03_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No