Bone Toxicity Following Pelvic Radiotherapy

Gynecologic Cancer Clinical Trial

— RadBone  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04555317
• Other study ID #: CFTSp180
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: August 2025

Study information

• Verified date: August 2023
• Source: The Christie NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fracture
• Gynecologic Cancer
• Radiotherapy Side Effect

Intervention

Combination Product:
• Musculoskeletal health package
3 month prehabilitation exercise program during radiotherapy with assessment of BMD at baseline with appropriate management according to fracture risk assessment (with either (a) lifestyle advice, (b) calcium and vitamin D (c) calcium, vitamin D and bisphosphonate (alendronate))

Locations

Country	Name	City	State
United Kingdom	Christie Hospital NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eligibility and screening rate	proportion of patients eligible for the study from the patient population	baseline
Primary	Recruitment and study group allocation rate	number of eligible patients recruited, randomised and allocated to appropriate study populations	2 weeks post consent
Primary	Recruitment and study group allocation rate	proportion of eligible patients recruited, randomised and allocated to appropriate study populations	2 weeks post consent
Primary	Intervention fidelity rate	number of patients completing the elements of the study	end of study 18 months
Primary	Intervention fidelity rate	proportion of patients completing the elements of the study	end of study 18 months
Primary	Attrition rate	number of patients lost to follow-up	end of study 18 months
Primary	Patient and physician acceptability y	Patient and physician acceptability assessed with electronic questionnaires	change from baseline to 6 months
Primary	Patient and physician acceptability y	Patient and physician acceptability assessed with electronic questionnaires	change from baseline to 12 months
Primary	Patient and physician acceptability y	Patient and physician acceptability assessed with electronic questionnaires	change from baseline to 18 months
Primary	Health Economic QOL Analysis	EuroQol-5D-5L Quality of Life assessment	change from baseline to 6 months
Primary	Health Economic QOL Analysis	EuroQol-5D-5L Quality of Life assessment	change from baseline to 12 months
Primary	Health Economic QOL Analysis	EuroQol-5D-5L Quality of Life assessment	change from baseline to 18 months
Secondary	Incidence of Radiotherapy Related Insufficiency Fracture (RRIF)	Incidence of RRIF assessed by MR	assessed at 6, 12 , 18 months post radiotherapy
Secondary	Longitudinal change in BMD	BMD measured by DXA at baseline and 18 months	assessed at baseline and 18 months
Secondary	Longitudinal change in fracture risk using FRAX (inc BMD by DXA)	FRAX assessment tool (including femoral neck BMD)	assessed at baseline and 18 months
Secondary	Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 2
Secondary	Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 3
Secondary	Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 4
Secondary	Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 5
Secondary	Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 6
Secondary	Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 7
Secondary	Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 8
Secondary	Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to week 9
Secondary	Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to 6 months
Secondary	Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to 12 months
Secondary	Longitudinal change in biochemical markers of bone turnover (BTM)	serum Bone Turnover Markers	change from baseline to 18 months
Secondary	Quality of Life Assessment : adapted CTCAE pelvic questionnaire	CTCAE pelvic questionnaire, (common terminology criteria for adverse events). (measures: Bowel questions scored out of 22, urinary questions out of 19 and sexual questions out of 8. Total out of 49: higher score = worse quality of life)	change from baseline to 6 months
Secondary	Quality of Life Assessment : adapted CTCAE pelvic questionnaire	CTCAE pelvic questionnaire, (common terminology criteria for adverse events). (measures: Bowel questions scored out of 22, urinary questions out of 19 and sexual questions out of 8. Total out of 49: higher score = worse quality of life)	change from baseline to 12 months
Secondary	Quality of Life Assessment : adapted CTCAE pelvic questionnaire	CTCAE pelvic questionnaire, (common terminology criteria for adverse events). (measures: Bowel questions scored out of 22, urinary questions out of 19 and sexual questions out of 8. Total out of 49: higher score = worse quality of life)	change from baseline to 18 months
Secondary	Quality of Life Assessment: SMFA adapted to lower limbs	adapted SMFA : short form musculoskeletal function assessment (scores are standardised with high scores indicating poor function. 39 questions min score possible 39, max score possible 195 (raw scores)	change from baseline to 6 months
Secondary	Quality of Life Assessment: SMFA adapted to lower limbs	adapted SMFA : short form musculoskeletal function assessment (scores are standardised with high scores indicating poor function. 39 questions min score possible 39, max score possible 195 (raw scores)	change from baseline to 12 months
Secondary	Quality of Life Assessment: SMFA adapted to lower limbs	adapted SMFA : short form musculoskeletal function assessment (scores are standardised with high scores indicating poor function. 39 questions min score possible 39, max score possible 195 (raw scores)	change from baseline to 18 months