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

NCT05975190 | Unknown

• 1 other identifier: 2020-277_1-S-NP
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Radiotherapy; Breast Cancer; Relaxation; Breathholding

Keywords

Adjuvant radiotherapy for Breast Cancer; DIBH in left sided Breast Cancer; Respiratory and Relaxation Techniques; patients compliance; active participation under radiotherapy

Outcome Measures

Primary Outcomes (1)

• Change of Dmax to the heart in DIBH under adjuvant radiotherapy of left sided breast cancer

  Maximum Dose to the heart (Dmax) in deep inspiration during adjuvant radiotherapy for breast cancer in dependence of the use of communication training and the use of relaxation techniques

  during treatment (4 weeks)

Secondary Outcomes (8)

• Improving quality of life under radiotherapy of left sided breast cancer

  - at baseline - during treatment (4 weeks) - at 6 week Follow-Up

• Improving heart Dmean under radiotherapy of left sided breast cancer

  during treatment (4 weeks)

• Improving Left anterior descending (LAD) Dmean under radiotherapy of left sided breast cancer

  during treatment (4 weeks)

• Improving LAD Dmax under radiotherapy of left sided breast cancer

  during treatment (4 weeks)

• Improving left ventricle (LV) Dmean under radiotherapy of left sided breast cancer

  during treatment (4 weeks)

Study Arms (2)

R&R arm (interventional arm)

EXPERIMENTAL

The training program in the experimental arm includes relaxation techniques, breath hold training, music, and nature sounds that patients can listen to on an MP3 player. The training is offered one week before the planning CT scan and patients are encouraged to practice independently. Patients 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.

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

Standard arm

NO INTERVENTION

Patients in the standard arm receive current conventional DIBH instruction without an extended R\&R training. Patients 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.

Interventions

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

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

R&R arm (interventional arm)

Eligibility Criteria

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

You may qualify if:

• Female breast cancer patients
• Left sided breast cancer
• Treated with surgery prior to radiotherapy
• WHO performance status 0-1
• Planned for radiotherapy alone to the breast, the chest wall and/or the lymph node areas
• Radiotherapy based on planning-CT scan using either 3D-CRT, IMRT, or VMAT/RapidArc
• Written Informed consent

You may not qualify if:

• Age \<18 years
• Pregnancy, Breastfeeding
• Previous thoracic or mediastinal radiation
• Bilateral breast cancer
• Partial breast irradiation
• M1 disease (metastatic breast cancer)
• Severe lung disease

Sponsors & Collaborators

• Technical University of Munich: lead
• German Cancer Aid: collaborator

Study Sites (1)

Department of Radiation Oncology, Technical University of Munich

Munich, 81675, 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

• Stephanie Combs, MD

  Department of Radiation Oncology, Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Borm, MD

CONTACT

0049-89-4140-4501; kai.borm@mri.tum.de

Rebecca Asadpour, MD

CONTACT

0049-89-4140-4501; rebecca.asadpour@mri.tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The randomized design of the study will test R\&R interventions compared to current conventional DIBH instruction.

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 3, 2023
• Study Start: June 22, 2022
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)