Clinical trial · Interventional
The Prone Breast Radiation Therapy Trial
A Multicentre Randomized Controlled Clinical Trial for the Reduction of Acute Skin Reaction in Adjuvant Breast Radiation in Large Breasted Women Using a Prone Technique - The Prone Breast Trial
- 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)
Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk of developing a skin reaction because of their large breast size. After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or early stage invasive breast cancer receive radiation to the breast to decrease the risk of cancer recurrence. Breast radiation is usually done with women lying on their back ("supine"). Some women develop temporary breakdown of the skin (moist desquamation). This skin reaction can be painful and has been linked to long term side effects such as chronic pain and decreased quality of life. This study is being done because women with large breasts have higher rates of skin breakdown (called 'moist desquamation') and breast pain during and shortly after radiation therapy is complete. It is unclear if such skin reactions and pain would be improved by alternating treatment position - namely lying on your belly ("prone") during their radiation treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy Positioning Intervention | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- RT Positioning Intervention: Supine
- description
- Patient will be treated in a supine position as per standard of care/control.
- interventionNames
- Radiation: Radiation Therapy Positioning Intervention
- type
- EXPERIMENTAL
- label
- RT Positioning Intervention: Prone
- description
- Patient will be treated in the prone position.
- interventionNames
- Radiation: Radiation Therapy Positioning Intervention
Primary outcomes (1)
- measure
- Moist Desquamation
- timeFrame
- 6-8 week post-treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ (DCIS); * treated with BCT; * no indication for treatment of regional LN; * Women with a bra size of 40 inches or greater, or a pre-surgery cup size of D or greater Exclusion Criteria: * Regional Lymph Node XRT indicated; * Bilateral breast cancer; * unhealed wound (skin not closed and/or infection); * previous XRT to the same breast; * unable to lie prone; * presence of active connective tissue disease; * pregnancy; * unacceptable heart exposure (as measured by \> 10% of the heart receiving 50% of the prescribed dose, i.e. V25Gy \> 10%); * adequate coverage of postoperative tumour bed not technically possible
References
Publications (1)
- DERIVEDVesprini D, Davidson M, Bosnic S, Truong P, Vallieres I, Fenkell L, Comsa D, El-Mallah M, Garcia L, Stevens C, Nakonechny K, Tran W, Kiss A, Rakovitch E, Pignol JP. Effect of Supine vs Prone Breast Radiotherapy on Acute Toxic Effects of the Skin Among Women With Large Breast Size: A Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):994-1000. doi: 10.1001/jamaoncol.2022.1479. PMID 35616948