Prospective Assessment of Quality of Life in Patients With Locally Recurrent Breast Cancer and Hyperthermic Radiotherapy

NCT ID: NCT04878666

Last Updated: 2021-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vanessa Heinrich, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tübingen

Locations

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University Hospital Tübingen, Department of Radiation Oncology

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Vanessa Heinrich, MD

Role: CONTACT

+49 (0) 7071 29- ext. 82165

Daniel Zips, MD, Prof.

Role: CONTACT

+49 (0) 7071 29- ext. 82165

Facility Contacts

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Vanessa Heinrich, MD

Role: primary

+49 (0)7071 29- ext. 82165

Daniel Zips, MD, Prof.

Role: backup

+49 (0)7071 29- ext. 82165

Other Identifiers

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UKT HT03_1

Identifier Type: -

Identifier Source: org_study_id

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