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Comparing 3-D Printed vs Standard Bolus for Breast Cancer Chest Wall Radiotherapy

NCT02544945 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-01-31

No results posted yet for this study

Summary

This is a cohort study of 16 women undergoing post-mastectomy chest wall radiotherapy for breast cancer comparing two ways of modifying the radiation beam with bolus (a 5mm rubber substance placed on the skin to modify the radiation beam). The hypothesis is that 3D printed bolus will conform more closely to the chest wall than standard 5mm-thick standard bolus and thus lead to less chance of underdose or overdose of the skin. Each patient will receive the standard dose of radiotherapy, but half the treatments will use standard bolus and half the treatments will 3D printed bolus (ie each patient will act as is their own control). The primary outcome is the comparison of the amount of air under the bolus for each technique. Secondary outcome is the amount of time it takes to set up the patient for radiotherapy.

Conditions

Interventions

OTHER

3D printed bolus

Using the Cat Scan for treatment planning, a 3D plastic shell can be produced which is shaped exactly to the shape of the patient's chest wall. This shell will act as bolus - the substance that is placed on the skin during chest wall radiotherapy. The bolus allows the right dose of radiotherapy to get to the skin and the underlying chest wall.

OTHER

Standard bolus

A standard 5mm-thick piece of rubber is placed on the patient's chest wall

Sponsors & Collaborators

  • Nova Scotia Health Authority

    collaborator OTHER

  • Rob Rutledge

    lead OTHER

Principal Investigators

  • Robert DH Rutledge, MD · Capital Health, Canada

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-07-31
Completion
2017-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02544945 on ClinicalTrials.gov