Clinical trial NCT04555317: Bone Toxicity Following Pelvic Radiotherapy
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Radiotherapy Side Effect
Fracture
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to either an observational arm or an interventional arm consisting of a musculoskeletal health package
Primary purpose: TREATMENT

Brief summary: A randomised controlled clinical feasibility trial to determine the feasibility and acceptability of a "musculoskeletal health package (MHP)" intervention in women undergoing pelvic radiotherapy for gynaecological malignancies and inform power calculations for a definitive trial.


Eligibility criteria: Inclusion Criteria:

* age over 18 years
* histologically confirmed uterine or cervix cancer
* patients undergoing potentially curative/adjuvant radiotherapy
* ability to give informed consent to participate

Exclusion Criteria:

* age less than 18 years or greater than 85 years
* patients with pre-existing bone conditions such as: osteoporosis treated with bisphosphonates in the previous 5 years/fibrous dysplasia/osteogenesis imperfecta or other metabolic bone condition
* inability to give informed consent to participate
* home address outside Greater Manchester
* contraindication or intolerance of Magnetic Resonance scanning

Primary outcomes:
measure: Eligibility and screening rate
timeFrame: baseline
measure: Recruitment and study group allocation rate
timeFrame: 2 weeks post consent
measure: Recruitment and study group allocation rate
timeFrame: 2 weeks post consent
measure: Intervention fidelity rate
timeFrame: end of study 18 months
measure: Intervention fidelity rate
timeFrame: end of study 18 months
measure: Attrition rate
timeFrame: end of study 18 months
measure: Patient and physician acceptability y
timeFrame: change from baseline to 6 months
measure: Patient and physician acceptability y
timeFrame: change from baseline to 12 months
measure: Patient and physician acceptability y
timeFrame: change from baseline to 18 months
measure: Health Economic QOL Analysis
timeFrame: change from baseline to 6 months
measure: Health Economic QOL Analysis
timeFrame: change from baseline to 12 months
measure: Health Economic QOL Analysis
timeFrame: change from baseline to 18 months
Secondary outcomes:
measure: Incidence of Radiotherapy Related Insufficiency Fracture (RRIF)
timeFrame: assessed at 6, 12 , 18 months post radiotherapy
measure: Longitudinal change in BMD
timeFrame: assessed at baseline and 18 months
measure: Longitudinal change in fracture risk using FRAX (inc BMD by DXA)
timeFrame: assessed at baseline and 18 months
measure: Longitudinal change in biochemical markers of bone turnover (BTM)
timeFrame: change from baseline to week 2
measure: Longitudinal change in biochemical markers of bone turnover (BTM)
timeFrame: change from baseline to week 3
measure: Longitudinal change in biochemical markers of bone turnover (BTM)
timeFrame: change from baseline to week 4
measure: Longitudinal change in biochemical markers of bone turnover (BTM)
timeFrame: change from baseline to week 5
measure: Longitudinal change in biochemical markers of bone turnover (BTM)
timeFrame: change from baseline to week 6
measure: Longitudinal change in biochemical markers of bone turnover (BTM)
timeFrame: change from baseline to week 7
measure: Longitudinal change in biochemical markers of bone turnover (BTM)
timeFrame: change from baseline to week 8
measure: Longitudinal change in biochemical markers of bone turnover (BTM)
timeFrame: change from baseline to week 9
measure: Longitudinal change in biochemical markers of bone turnover (BTM)
timeFrame: change from baseline to 6 months
measure: Longitudinal change in biochemical markers of bone turnover (BTM)
timeFrame: change from baseline to 12 months
measure: Longitudinal change in biochemical markers of bone turnover (BTM)
timeFrame: change from baseline to 18 months
measure: Quality of Life Assessment : adapted CTCAE pelvic questionnaire
timeFrame: change from baseline to 6 months
measure: Quality of Life Assessment : adapted CTCAE pelvic questionnaire
timeFrame: change from baseline to 12 months
measure: Quality of Life Assessment : adapted CTCAE pelvic questionnaire
timeFrame: change from baseline to 18 months
measure: Quality of Life Assessment: SMFA adapted to lower limbs
timeFrame: change from baseline to 6 months
measure: Quality of Life Assessment: SMFA adapted to lower limbs
timeFrame: change from baseline to 12 months
measure: Quality of Life Assessment: SMFA adapted to lower limbs
timeFrame: change from baseline to 18 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
Study officials:
References:
citation: Chatzimavridou Grigoriadou V, Barraclough LH, Baricevic-Jones I, Bristow RG, Eden M, Haslett K, Johnson K, Kochhar R, Merchant Z, Moore J, O'Connell S, Taylor S, Westwood T, Whetton AD, Yorke J, Higham CE. RadBone: bone toxicity following pelvic radiotherapy - a prospective randomised controlled feasibility study evaluating a musculoskeletal health package in women with gynaecological cancers undergoing pelvic radiotherapy. BMJ Open. 2022 Jun 14;12(6):e056600. doi: 10.1136/bmjopen-2021-056600.