BReath Hold TecHniquEs for Radiotherapy of Esophageal Carcinoma

NCT ID: NCT06317272

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2023-09-19

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABC DIBH

Active Breathing Controlled (ABC) technique for deep breath inspiration hold (DIBH)

Group Type ACTIVE_COMPARATOR

DIBH using ABC technique

Intervention Type OTHER

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

VC DIBH

Voluntary Coached (VC) technique for deep breath inspiration hold (DIBH)

Group Type EXPERIMENTAL

DIBH using VC technique

Intervention Type OTHER

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

Interventions

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DIBH using ABC technique

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

Intervention Type OTHER

DIBH using VC technique

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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C.T. Muijs, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Groningen

Locations

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UMC Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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RT2016-04-BROTHER Part 1

Identifier Type: -

Identifier Source: org_study_id

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