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
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.Summary of Results
A study looking at bone health in women having pelvic radiotherapy for cancer. PI: Dr Claire Higham.
Patient and Public Involvement:
Patients and members of the public helped shape this study from the beginning. The original study plan was developed with support from people who had experience of pelvic radiotherapy and from the UK Pelvic Radiation Disease Association.
After the study ended, participants were invited to online meetings led by VOCAL, a patient involvement organisation. Researchers shared the early results and discussed what the findings might mean for future research. Another meeting was also held for patients who had not taken part in the study, carers, and members of the public.
Because not everyone could attend these events, a paper summary has also been prepared so that all participants can learn about the study results.
Participants:
People were recruited from gynaecology and anal-rectal cancer clinics at The Christie Hospital in Manchester between May 2021 and February 2023.
Background:
Pelvic radiotherapy is an important treatment for several cancers. However, it can sometimes weaken bones in the pelvis and increase the risk of fractures called radiotherapy-related insufficiency fractures (RRIFs).
These fractures can cause pain, make it harder to walk and move around, reduce quality of life, and increase the need for medical care. At present, there is no proven way to predict who will get these fractures or how to prevent them.
The RadBone study was designed to find out whether a musculoskeletal health package (MHP) of support focused on bone health could help patients. Researchers also wanted to learn more about why these fractures happen and whether people at higher risk could be identified earlier.
Aims:
The study looked at three main questions:
• Can a bone health support package be delivered successfully to people having pelvic radiotherapy, and is it acceptable to patients?
• Can doctors identify people who are most likely to develop pelvic fractures by using scans, blood tests, and other health information?
• What changes happen in the bones after radiotherapy that may lead to fractures, and could these changes be targeted with future treatments?
The overall goal was to improve understanding of these fractures and help prevent them in the future.
Methods:
The study originally involved women with cervical or endometrial cancer who were receiving pelvic radiotherapy. Because recruitment was affected by the COVID-19 pandemic, women receiving treatment for anal-rectal cancers were later included as well.
Participants were placed into one of two groups.
One group received usual care. The second group received a Musculoskeletal Health Package (MHP), which focused on improving bone health.
At the start of the study, everyone had bone density scans, blood tests, fracture risk assessments and completed questionnaires about their health and wellbeing.
People in the MHP group could receive vitamin D and calcium supplements, medicines that strengthen bones, advice on reducing risk factors for poor bone health, and a structured exercise programme through the Greater Manchester Prehab4Cancer service.
All participants were followed for 18 months and attended regular appointments, scans, blood tests and quality of life assessments.
Adverse Events:
Many participants experienced health problems during the study, but this is common in people receiving cancer treatment.
There were 89 adverse events recorded in the MHP group and 99 in the usual care group.
Only one event was thought to be directly related to the bone health package. One participant developed stomach problems linked to a bone-strengthening medicine. The treatment was changed and no further problems occurred.
No deaths were related to the study treatment. Some participants became more unwell because of their cancer and could not complete the study.
Results:
A total of 767 people due to receive pelvic radiotherapy were screened. Of these, 102 were eligible and 41 agreed to take part.
Twenty-one participants joined the usual care group and 20 joined the MHP group. Most participants completed the study, although six left early because of health issues unrelated to the research.
The results showed that:
• The MHP was practical to deliver and was generally well accepted by participants. Most study activities were completed successfully. Researchers also found that collecting information about healthcare costs and quality of life was possible and useful.
• Some participants found the exercise diary confusing and parts of the exercise programme will need to be improved for people receiving pelvic radiotherapy in future studies.
• Pelvic fractures occurred in 1 of 17 participants in the MHP group compared with 3 of 19 participants in the usual care group. the number of participants was too small to draw firm conclusions about this difference.
• Bone scans suggested that people in the MHP group lost less bone density over time than those receiving usual care.
• Blood tests identified several proteins that may be linked to fracture risk. Further analysis is still underway.
• Researchers also found some differences in markers of bone turnover between the two groups, which may help explain how fractures develop.
Because this was a small study, these findings must be interpreted with caution.
Discussion and Future Plans:
The study showed that the Musculoskeletal Health Package is both possible to deliver and acceptable to patients receiving pelvic radiotherapy.
Early results suggest it may help protect bone health and reduce the risk of fractures. The study also identified possible biological markers that could help predict fracture risk in the future.
Patient feedback has highlighted areas where study materials and the exercise programme can be improved.
Researchers are now planning a larger UK-wide study called RadBone UK, working with Cardiff Clinical Trials Unit. This larger study will test the approach in more patients and provide stronger evidence about whether the programme improves bone health after pelvic radiotherapy.
More Information:
Dr Louise James
Project Manager
louise.james22@nhs.netREC 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