Clinical trial · Interventional
Comparing 3-D Printed vs Standard Bolus for Breast Cancer Chest Wall Radiotherapy
Comparing 3-D Printed vs Standard Bolus for Breast Cancer Chest Wall Radiotherapy: A Feasibility Study Measuring Bolus Spatial Accuracy, Dosimetric Accuracy and Treatment Set-up Time
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D printed bolus | Other | — | UNRESOLVED |
| Standard bolus | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Bolus
- description
- The radiotherapy treatment days when the standard bolus is used
- interventionNames
- Other: Standard bolus
- type
- EXPERIMENTAL
- label
- 3D printed bolus
- description
- the radiotherapy treatment days when the 3D bolus is used
- interventionNames
- Other: 3D printed bolus
Primary outcomes (1)
- measure
- Air gap under bolus
- timeFrame
- Up to 3 month
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women undergoing radiotherapy to the chest wall for the treatment of breast cancer with radical intent. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available