RadBone
Research type
Research Study
Full title
Bone Toxicity following Pelvic Radiotherapy: A prospective randomised controlled feasibility study evaluating a musculoskeletal health package in women with gynaecological cancers undergoing pelvic radiotherapy
IRAS ID
278108
Contact name
Claire E Higham
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Radiotherapy to the pelvis is used to treat cancers of the womb and cervix. This can cause cracks or breaks (fractures) in the pelvic bones (radiotherapy related insufficiency fractures or “RIFFs”). RIFFs can cause pain, problems with moving and affect quality of life. Currently we do not know how much the radiotherapy treatment is to blame for the fractures, we don’t know if we can predict which patients are likely to develop RIFFs or if there is anything that can be done to prevent the damage occurring during radiotherapy treatment.
As the type of cancer treatment given cannot be changed, we want to see if we can develop a Musculoskeletal Health Package (MHP) that can improve muscle and bone strength and function to reduce RIFFs. This will include the following (1) screening for osteoporosis with a DXA scan to measure bone density; we can then use this, along with other risk factors to calculate a fracture risk (2) checking vitamin D and looking at calcium levels in the diet, both of which are important for bone health (3) using a bisphosphonate (a drug used to prevent bone weakness and fractures in osteoporosis) if risk of fracture is high according to our fracture prediction (4) a prehabilitation exercise program, designed as part of the Greater Manchester prehab4cancer programme, including bespoke exercise delivered by experts.
The aim of this project is to perform a randomised controlled feasibility trial in women having pelvic radiotherapy; to understand whether a trial of the MHP is something that is feasible, that patients will want to take part in, not drop out of and find tolerable. We can also look at how much the intervention would cost in relation to improvements in quality of life.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
20/NW/0410
Date of REC Opinion
1 Dec 2020
REC opinion
Further Information Favourable Opinion