Contact information
Type
Scientific
Primary contact
Ms Heidi Probst
ORCID ID
Contact details
Cookridge Hospital
Yorkshire Centre for Clinical Oncology
Hospital Lane
Leeds
LS16 6QB
United Kingdom
+44 (0)113 392 4104
HEIDIP@ulth.northy.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0461053544
Study information
Scientific title
Investigating the protocols for radiotherapy to the breast: an evaluation of treatment morbidity, accuracy and efficiency
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
10/01/1999
Overall trial end date
12/01/2001
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
10/01/1999
Recruitment end date
12/01/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cookridge Hospital
Leeds
LS16 6QB
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK) (ref: RRCC715F Probst)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list