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
Secondary identifying numbers N0461053544
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleInvestigating the protocols for radiotherapy to the breast: an evaluation of treatment morbidity, accuracy and efficiency
Study objectivesThe 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) studiedBreast cancer
InterventionPatients that consent to participate are randomised to one of two lung depth groups and one of two skin marking categories.
Intervention typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date10/01/1999
Completion date12/01/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaAll patients diagnosed with stage I and II breast cancer referred for adjuvant radiotherapy under three specialist breast oncologists (at Cookridge Hospital, Leeds)
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment10/01/1999
Date of final enrolment12/01/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Cookridge Hospital
Leeds
LS16 6QB
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK) (ref: RRCC715F Probst)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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