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

NCT02544945 | Completed DMC

• 1 other identifier: 3DBolus
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Air gap under bolus

  Air gap is defined as a) the greatest distance from the skin to the bolus measured perpendicular to the chest wall, and b) the maximal area of skin underlying the maximal air pocket

  Up to 3 month

Secondary Outcomes (1)

• Set up time

  Up to 3 months

Study Arms (2)

Standard Bolus

ACTIVE COMPARATOR

The radiotherapy treatment days when the standard bolus is used

Other: Standard bolus

3D printed bolus

EXPERIMENTAL

the radiotherapy treatment days when the 3D bolus is used

Other: 3D printed bolus

Interventions

3D printed bolus OTHER

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.

3D printed bolus

Standard bolus OTHER

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

Standard Bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing radiotherapy to the chest wall for the treatment of breast cancer with radical intent.

You may not qualify if:

• Patients in whom the Radiation Oncologist plans to either omit bolus for more than half of the treatments (rarely happens).
• Patients undergoing a non-standard chest-wall technique (eg. VMAT)
• Pregnant or plans to get pregnant during radiotherapy
• Inability to obtain informed consent or adhere to the protocol

Sponsors & Collaborators

• Rob Rutledge: lead
• Nova Scotia Health Authority: collaborator

Study Sites (1)

NSHA-QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert DH Rutledge, MD

  Capital Health, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Radiation Oncologist

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: September 9, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

CA (1)