Arm-ACHE study
Research type
Research Study
Full title
Arm symptoms following Anthracycline Chemotherapy in Breast Cancer: An observational study
IRAS ID
200407
Contact name
Rosemary Roberts
Contact email
Sponsor organisation
Velindre NHS Trust
Duration of Study in the UK
2 years, 7 months, 27 days
Research summary
An observational study of the extent to which breast cancer patients experience vein symptoms following treatment with anthracycline chemotherapy (AC).
AC when given through a cannula in the hand or arm can cause vein irritation resulting in arm symptoms including pain, redness and swelling. The extent of these symptoms varies greatly, with some patients experiencing no arm symptoms, while a small number experience severe symptoms which can restrict their normal daily activities and last for weeks or months. Currently we do not understand why some patients experience no arm symptoms and others have severe symptoms.
Giving chemotherapy through a central venous catheter (CVC) prevents vein irritation (a CVC is a fine tube inserted into a large vein in the upper arm or chest). CVCs are not routinely recommended for chemotherapy due to the small but potentially serious risk of infections and blood clots. This study aims to identify if there are any factors which can predict who is at risk of developing severe symptoms to enable an informed decision concerning whether a CVC should be recommended to prevent arm symptoms.
The study is being conducted as part of a PhD programme and is funded by Velindre Cancer Centre and University of South Wales. 500 women with breast cancer starting a course of AC at Velindre will be recruited over 18 -24 months. Arm symptoms experienced will be assessed and graded by both clinical staff and participants (who will complete a short self-assessment questionnaire) once every 3 weeks during chemotherapy, and for up to 6 months after chemotherapy. Information about treatment related factors such as dose and number of AC cycles as well as patient related factors including age, medication and other medical conditions will be collected from participant medical records and a baseline questionnaire.REC name
Wales REC 2
REC reference
16/WA/0074
Date of REC Opinion
23 Mar 2016
REC opinion
Further Information Favourable Opinion