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

NCT04878666 | Recruiting

• 1 other identifier: UKT HT03_1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

Hyperthermic Radiotherapy; Quality of Life; locally recurrent Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tübingen, Department of Radiation Oncology

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vanessa Heinrich, MD

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Heinrich, MD

CONTACT

+49 (0) 7071 29-; vanessa.heinrich@med.uni-tuebingen.de

Daniel Zips, MD, Prof.

CONTACT

+49 (0) 7071 29-; ro-info@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: May 7, 2021
• Study Start: August 1, 2020
• Primary Completion: December 31, 2021
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 7, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)