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NCT Number: NCT04878666

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: During hyperthermic radiotherapy up to five years of follow-up.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Zips, MD, Prof.

CONTACT

[email protected]

+49 (0) 7071 29- ext. 82165

Vanessa Heinrich, MD

CONTACT

[email protected]

+49 (0) 7071 29- ext. 82165

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Acronym: UKT HT03_1

Important dates

Study start
2020
Primary completion
2021
Study completion
2026
First posted
May 7, 2021
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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