NCT04555317

Bone Toxicity Following Pelvic Radiotherapy

Bone Toxicity Following Pelvic Radiotherapy: A Prospective Randomised Controlled Feasibility Study Evaluating a Musculoskeletal Health Package in Women With Gynaecological Cancers Undergoing Pelvic Radiotherapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The Christie NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynecologic Cancer
• Radiotherapy Side Effect
• Fracture

Interventions

Type	Name	Description
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))

Timeline

• Start date: 2021-05-17
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2020-09-18
• Last updated: 2023-11-01

Locations

1 site across 1 country: United Kingdom