RadBone: Bone Toxicity Following Pelvic Radiotherapy

• Sponsor: The Christie NHS Foundation Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04555317
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24.5
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Cancer; Radiotherapy Side Effect; Fracture	Combination Product: Musculoskeletal health package	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be randomly assigned to either an observational arm or an interventional arm consisting of a musculoskeletal health packagePatients will be randomly assigned to either an observational arm or an interventional arm consisting of a musculoskeletal health package
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 17, 2021
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of Care No intervention. Standard of care cancer pathway followed.
Active Comparator: Musculoskeletal Health Package 3 month prehabilitation exercise program during radiotherapy and 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))	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))

Outcome Measures

Primary Outcome Measures

1. Eligibility and screening rate [baseline]

   proportion of patients eligible for the study from the patient population

2. Recruitment and study group allocation rate [2 weeks post consent]

   number of eligible patients recruited, randomised and allocated to appropriate study populations

3. Recruitment and study group allocation rate [2 weeks post consent]

   proportion of eligible patients recruited, randomised and allocated to appropriate study populations

4. Intervention fidelity rate [end of study 18 months]

   number of patients completing the elements of the study

5. Intervention fidelity rate [end of study 18 months]

   proportion of patients completing the elements of the study

6. Attrition rate [end of study 18 months]

   number of patients lost to follow-up

7. Patient and physician acceptability y [change from baseline to 6 months]

   Patient and physician acceptability assessed with electronic questionnaires

8. Patient and physician acceptability y [change from baseline to 12 months]

   Patient and physician acceptability assessed with electronic questionnaires

9. Patient and physician acceptability y [change from baseline to 18 months]

   Patient and physician acceptability assessed with electronic questionnaires

10. Health Economic QOL Analysis [change from baseline to 6 months]

    EuroQol-5D-5L Quality of Life assessment

11. Health Economic QOL Analysis [change from baseline to 12 months]

    EuroQol-5D-5L Quality of Life assessment

12. Health Economic QOL Analysis [change from baseline to 18 months]

    EuroQol-5D-5L Quality of Life assessment

Secondary Outcome Measures

1. Incidence of Radiotherapy Related Insufficiency Fracture (RRIF) [assessed at 6, 12 , 18 months post radiotherapy]

   Incidence of RRIF assessed by MR

2. Longitudinal change in BMD [assessed at baseline and 18 months]

   BMD measured by DXA at baseline and 18 months

3. Longitudinal change in fracture risk using FRAX (inc BMD by DXA) [assessed at baseline and 18 months]

   FRAX assessment tool (including femoral neck BMD)

4. Longitudinal change in biochemical markers of bone turnover (BTM) [change from baseline to week 2]

   serum Bone Turnover Markers

5. Longitudinal change in biochemical markers of bone turnover (BTM) [change from baseline to week 3]

   serum Bone Turnover Markers

6. Longitudinal change in biochemical markers of bone turnover (BTM) [change from baseline to week 4]

   serum Bone Turnover Markers

7. Longitudinal change in biochemical markers of bone turnover (BTM) [change from baseline to week 5]

   serum Bone Turnover Markers

8. Longitudinal change in biochemical markers of bone turnover (BTM) [change from baseline to week 6]

   serum Bone Turnover Markers

9. Longitudinal change in biochemical markers of bone turnover (BTM) [change from baseline to week 7]

   serum Bone Turnover Markers

10. Longitudinal change in biochemical markers of bone turnover (BTM) [change from baseline to week 8]

    serum Bone Turnover Markers

11. Longitudinal change in biochemical markers of bone turnover (BTM) [change from baseline to week 9]

    serum Bone Turnover Markers

12. Longitudinal change in biochemical markers of bone turnover (BTM) [change from baseline to 6 months]

    serum Bone Turnover Markers

13. Longitudinal change in biochemical markers of bone turnover (BTM) [change from baseline to 12 months]

    serum Bone Turnover Markers

14. Longitudinal change in biochemical markers of bone turnover (BTM) [change from baseline to 18 months]

    serum Bone Turnover Markers

15. Quality of Life Assessment : adapted CTCAE pelvic questionnaire [change from baseline to 6 months]

    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)

16. Quality of Life Assessment : adapted CTCAE pelvic questionnaire [change from baseline to 12 months]

    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)

17. Quality of Life Assessment : adapted CTCAE pelvic questionnaire [change from baseline to 18 months]

    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)

18. Quality of Life Assessment: SMFA adapted to lower limbs [change from baseline to 6 months]

    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)

19. Quality of Life Assessment: SMFA adapted to lower limbs [change from baseline to 12 months]

    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)

20. Quality of Life Assessment: SMFA adapted to lower limbs [change from baseline to 18 months]

    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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christie Hospital NHS Foundation Trust	Manchester		United Kingdom	M20 4BX

Sponsors and Collaborators

• The Christie NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Christie NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04555317
• Other Study ID Numbers: CFTSp180
• First Posted: Sep 18, 2020
• Last Update Posted: May 6, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 6, 2022