NCT06317272

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

2.6 years

First QC Date

February 27, 2024

Last Update Submit

March 11, 2024

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (2)

  • Feasibility DIBH

    Breath hold maintained for \>20 seconds

    Week 1, 2, 3, 4, 5 during radiotherapy

  • Reproducibility DIBH

    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

Study Arms (2)

ABC DIBH

ACTIVE COMPARATOR

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

Other: DIBH using ABC technique

VC DIBH

EXPERIMENTAL

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

Other: DIBH using VC technique

Interventions

DIBH using ABC techniqueOTHER

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

ABC DIBH
DIBH using VC techniqueOTHER

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

VC DIBH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Serious respiratory distress
  • Contra-indication for fiducial marker placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Groningen

Groningen, Netherlands

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • C.T. Muijs, MD, PhD

    UMC Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: The participating patients will undergo weekly (during radiotherapy treatment) 2 CTs in DIBH; one using ABC and one using voluntary coaching (VC).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 19, 2024

Study Start

February 10, 2021

Primary Completion

September 19, 2023

Study Completion

September 19, 2023

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations

NL(1)