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BReath Hold TecHniquEs for Radiotherapy of Esophageal Carcinoma

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06317272
Acronym
BROTHER
Enrollment
1
Registered
2024-03-19
Start date
2021-02-10
Completion date
2023-09-19
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Brief summary

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.

Interventions

OTHERDIBH using ABC technique

Deep breath inspiration hold (DIBH) using Active Breathing Control (ABC) technique

OTHERDIBH using VC technique

Deep breath inspiration hold (DIBH) using Voluntary Coaching (VC) technique

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The participating patients will undergo weekly (during radiotherapy treatment) 2 CTs in DIBH; one using ABC and one using voluntary coaching (VC).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility DIBHWeek 1, 2, 3, 4, 5 during radiotherapyBreath hold maintained for \>20 seconds
Reproducibility DIBHWeek 1, 2, 3, 4, 5 during radiotherapyDiaphragm dome position within 1cm of the baseline CT Target coverage \>94% of the prescribed dose (at 98% of the ITV)

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026