Bone Toxicity Following Pelvic Radiotherapy (RadBone)

The Christie NHS Foundation Trust

Status: Active, not recruiting

Conditions: Radiotherapy Side Effect; Fracture; Gynecologic Cancer

Treatments: Combination Product: Musculoskeletal health package

Study type: Interventional

Funder types: Other

Identifiers

NCT04555317

CFTSp180

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

No intervention. Standard of care cancer pathway followed.

Musculoskeletal Health Package

Active Comparator group

Description:

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))

Treatment:

Combination Product: Musculoskeletal health package