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

NCT05975190 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2023-08-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancer

R\&R training provided on an MP3-player for daily practice

Sponsors & Collaborators

  • German Cancer Aid

    collaborator OTHER

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Stephanie Combs, MD · Department of Radiation Oncology, Technical University of Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2025-07-01
Completion
2025-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05975190 on ClinicalTrials.gov