Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis

Randomized Controlled Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00887523

Enrollment

100

Registered

2009-04-24

Start date

2009-07-31

Completion date

2021-03-08

Last updated

2022-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma

Brief summary

84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.

Interventions

BEHAVIORALradiation in prone position

radiation in prone position

BEHAVIORALradiation in supine position

radiation in supine position

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* female patients * multidisciplinary decision of adjuvant whole-breast irradiation (WBI) after lumpectomy for breast cancer * minimum 18 years * informed consent obtained, signed and dated before specific protocol procedures

Exclusion criteria

* mastectomy * need for axillary irradiation * bilateral breast irradiation * previous irradiation at the same time * mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study * patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

Design outcomes

Primary

Measure	Time frame
acute moist desquamation	weekly during radiotherapy and 1 month after radiotherapy

Secondary

Measure	Time frame
Late skin toxicity	at 6, 12, 18 and 24 months after radiotherapy
skin and lung fibrosis assessed with computed tomography	before radiotherapy and 1 month and 1 year after radiotherapy
Quality of life	at 1 year and 2 years after radiotherpay
Acute skin toxicity other than moist desquamation	weekly during radiotherapy and 1 month after radiotherapy
time of treatment delivery	daily during radiotherapy
single nucleotide polymorphisms associated with skin toxicity and breast fibrosis	1 blood sample before radiotherapy
dose-volume parameters	of planning

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026