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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    20
  • sponsor
    University Hospital Tuebingen
Updated on 15 May 2021

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.

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.

Details
Condition Breast Cancer, Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Clinical Study IdentifierNCT04878666
SponsorUniversity Hospital Tuebingen
Last Modified on15 May 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note