Investigating the protocols for radiotherapy to the breast: an evaluation of treatment morbidity, accuracy and efficiency

ISRCTN	ISRCTN34017998
DOI	https://doi.org/10.1186/ISRCTN34017998
Protocol serial number	N0461053544
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK) (ref: RRCC715F Probst)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 19/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Heidi Probst
Scientific

Cookridge Hospital
Yorkshire Centre for Clinical Oncology
Hospital Lane
Leeds
LS16 6QB
United Kingdom

Phone	+44 (0)113 392 4104
Email	HEIDIP@ulth.northy.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Investigating the protocols for radiotherapy to the breast: an evaluation of treatment morbidity, accuracy and efficiency
Study objectives	The principal research questions: 1. Does a reduction in the central lung depth of a tangential breast field correspond to a clinically measurable difference in patient reported respiratory symptoms? 2. What are the treatment and patient related factors that influence patient reported respiratory symptoms? 3. Does the method of skin marking affect the accuracy and reproducibility of the radiotherapy treatment? 4. Does the method of skin marking affect patient reports of perceived body image.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast cancer
Intervention	Patients that consent to participate are randomised to one of two lung depth groups and one of two skin marking categories.
Intervention type	Other
Primary outcome measure(s)	1. Quality of life, assessed using EORTC QLQ C- 30 pre treatment and ten week post treatment 2. Treatment accuracy assessed by measuring radiation field placement in relation to the patient's' anatomy on three portal images taken during the treatment course. Measurements are compared with dimensions calculated during the patient's' initial treatment planning session.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	12/01/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key inclusion criteria	All patients diagnosed with stage I and II breast cancer referred for adjuvant radiotherapy under three specialist breast oncologists (at Cookridge Hospital, Leeds)
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	10/01/1999
Date of final enrolment	12/01/2001

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Cookridge Hospital

Leeds
LS16 6QB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/02/2018: No publications found, verifying study status with principal investigator.
26/11/2015: No publications found on PubMed.