Bone Toxicity Following Pelvic Radiotherapy

NCT ID: NCT04555317

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gynecologic Cancer Radiotherapy Side Effect Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly assigned to either an observational arm or an interventional arm consisting of a musculoskeletal health package
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care

No intervention. Standard of care cancer pathway followed.

Group Type NO_INTERVENTION

No interventions assigned to this group

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))

Group Type ACTIVE_COMPARATOR

Musculoskeletal health package

Intervention Type COMBINATION_PRODUCT

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))

Interventions

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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))

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Christie NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Christie Hospital NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35701060 (View on PubMed)

Other Identifiers

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CFTSp180

Identifier Type: -

Identifier Source: org_study_id

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