BReath Hold TecHniquEs for Radiotherapy of Esophageal Carcinoma (BROTHER)

March 11, 2024 updated by: University Medical Center Groningen

BReath hOld TecHniquEs for Radiotherapy of Esophageal Carcinoma; a Feasibility Study - Part 1

The main objective of the first part of the study is to determine the most optimal method for DIBH (active breathing control vs voluntary coached) and its reproducibility. Based on these findings, one of these methods will be selected for part 2 of this study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically proven esophageal cancer of the mid or distal esophagus
  • Scheduled for external-beam photon radiotherapy with curative intention.
  • WHO 0-2.
  • Age >= 18 years
  • Written informed consent.

Exclusion Criteria:

  • Serious respiratory distress
  • Contra-indication for fiducial marker placement
  • Noncompliance with any of the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ABC DIBH
Active Breathing Controlled (ABC) technique for deep breath inspiration hold (DIBH)
Other: DIBH using ABC technique
Deep breath inspiration hold (DIBH) using Active Breathing Control (ABC) technique
Experimental: VC DIBH
Voluntary Coached (VC) technique for deep breath inspiration hold (DIBH)
Other: DIBH using VC technique
Deep breath inspiration hold (DIBH) using Voluntary Coaching (VC) technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility DIBH
Time Frame: Week 1, 2, 3, 4, 5 during radiotherapy
Breath hold maintained for >20 seconds
Week 1, 2, 3, 4, 5 during radiotherapy
Reproducibility DIBH
Time Frame: Week 1, 2, 3, 4, 5 during radiotherapy
Diaphragm dome position within 1cm of the baseline CT Target coverage >94% of the prescribed dose (at 98% of the ITV)
Week 1, 2, 3, 4, 5 during radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: C.T. Muijs, MD, PhD, UMC Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2021

Primary Completion (Actual)

September 19, 2023

Study Completion (Actual)

September 19, 2023

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT2016-04-BROTHER Part 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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