Condition category
Cancer
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
26/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 below 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 measures

1. Quality of life - patients are requested to complete the EORTC QLQ C- 30 pre treatment and ten week post treatment.
2. Treatment accuracy is assessed by measuring radiation field placement in relation to the patients' anatomy on three portal images taken during the treatment course. Measurements are compared with dimensions calculated during the patients' 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

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 match 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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/11/2015: no publications found on PubMed.