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NCT05975190: B-REST

Respiratory Training and Relaxation Techniques to Improve Adjuvant Radiation Therapy in DIBH in Breast Cancer

Status unknown NA Last updated 3 August 2023
What this trial tests

NA trial testing Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancer in Radiotherapy in 108 participants. Status unknown.

Timeline
22 June 2022
Primary endpoint
1 July 2025
31 December 2025

Quick facts

Lead sponsorTechnical University of Munich
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment108
Start date22 June 2022
Primary completion1 July 2025
Estimated completion31 December 2025
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Technical University of Munich

Who can join

18 and older, female only, with Radiotherapy or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this prospective clinical trial is to improve patient compliance and performance of deep inspiration breath hold (DIBH) to further reduce the cardiac dose from left breast radiation, and to improve cooperation and patient satisfaction through an active and formal pre-treatment respiratory training program combined with relaxation training (R\&R) in breast cancer patients undergoing adjuvant radiotherapy for left sided breast cancer. The main questions the study aims to answer are: * Does the use of communication training and the use of relaxation techniques (R\&R) reduce the Maximum dose to the heart (Dmax) and improve further heart dose parameters in deep inspiration during adjuvant radiotherapy for breast cancer? * Does R\&R improve longitudinal anxiety and quality of life under patients undergoing DIBH adjuvant radiotherapy for left sided breast cancer? Participants will be randomly assigned to either an experimental arm, which will receive the R\&R, versus a standard arm that will not receive the R\&R. * training program in the experimental arm includes breath hold training, music, and nature sounds that patients can listen to on an MP3 player * both groups complete standardized questionnaires about their well-being and satisfaction at prospective time points before, during the radiation treatment course, as well as at 6 weeks follow-up Researchers will compare the R\&R group (interventional arm) to current conventional DIBH instruction (standard group) to see if Dmax to the heart decreases and compliance and satisfaction under patients rises.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Assessment of the impact of age on DIBH in radiotherapy based on the prospective GATTUM and B-REST trials.
    Moser R, Buchecker LM, Bohlen JM, Düsberg M, et al · · 2025 · PMID 40612359 · DOI 10.1016/j.ctro.2025.100956

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Other recruiting trials for Radiotherapy

Currently open trials in the same condition.

Other Technical University of Munich trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05975190.

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