Thermal Testing in Bone Pain (TiBoP)

NCT02887833 | Completed

• 1 other identifier: 16/SC/0260
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

If cancer spreads to bones it can be very painful, especially when trying to move around. One of the best treatments is radiotherapy, which has to be given in a cancer centre. Even with this treatment, only about half of people will get good pain relief, and that can take up to 6 weeks to work fully. If we know who is unlikely to benefit , then we can explore other forms of pain relief sooner, without having to go through radiotherapy unnecessarily. We have found that there may be a very simple way to identify patients likely to get good pain relief, using a test of changes in temperature sensation over the painful bone. This study will explore whether this simple bedside test can be used in a community setting to identify which patients suffering from cancer induced bone pain will get good pain relief from radiotherapy.

Conditions

Cancer Induced Bone Pain; Secondary Malignant Neoplasm of Bone; Toxicity Due to Radiotherapy; Pain

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the thermal sensitivity score in CIBP with respect to experiencing a "positive outcome" after XRT

  A positive outcome is defined as: at least 30% reduction in BPI pain at 6 weeks AND no increase in opioid medication use within 6 weeks AND no toxicity from XRT at 2 weeks.

  6 weeks

Secondary Outcomes (2)

• Sensitivity and specificity of thermal testing with respect to experiencing a positive outcome

  12 weeks

• Change in validated self report measures of the pain experience

  2,6,12 weeks

Study Arms (1)

XRT for Cancer induced bone pain

Will have community based assessment before and after radiotherapy to assess feasibility of using a clinical biomarker (thermal sensory testing) to predict treatment response

Other: Clinical biomarker (thermal sensory testing)

Interventions

Clinical biomarker (thermal sensory testing) OTHER

Thermal sensitivity testing: The area of CIBP and a corresponding unaffected (control) area will be assessed using warm and cool thermal rollers (Rolltemp, Somedic, Sweden). The control area will either be the contralateral side, or an area proximal to the affected site.

XRT for Cancer induced bone pain

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cancer induced bone pain scheduled to undergo palliative radiotherapy for this

You may qualify if:

• diagnosis of cancer with pain related to bony disease (pain ≥4/10 on a numerical pain rating scale);
• due to receive XRT for CIBP;
• outpatient;
• age 18-100;
• able to complete assessment and give written informed consent.

You may not qualify if:

• they are confused or suffering from significant psychiatric illness
• their condition is unstable or rapidly deteriorating
• they have any other medical condition that would confound the objectives of the study
• they who would be adversely affected by study participation. This would include those who are unaware of the presence of progressive disease or who would, in the opinion of the medical team, find completion of the study too burdensome
• they would be unable to complete the study protocol for any other reason

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Edinburgh Cancer Centre

Edinburgh, EH4 2XU, United Kingdom

Location

Related Publications (3)

• Laird BJ, Walley J, Murray GD, Clausen E, Colvin LA, Fallon MT. Characterization of cancer-induced bone pain: an exploratory study. Support Care Cancer. 2011 Sep;19(9):1393-401. doi: 10.1007/s00520-010-0961-3. Epub 2010 Aug 1.

  PMID: 20680354 BACKGROUND

• Delaney A, Fleetwood-Walker SM, Colvin LA, Fallon M. Translational medicine: cancer pain mechanisms and management. Br J Anaesth. 2008 Jul;101(1):87-94. doi: 10.1093/bja/aen100. Epub 2008 May 19.

  PMID: 18492671 BACKGROUND

• Parker RA, Sande TA, Laird B, Hoskin P, Fallon M, Colvin L. Bayesian methods in palliative care research: cancer-induced bone pain. BMJ Support Palliat Care. 2022 May;12(e1):e5-e9. doi: 10.1136/bmjspcare-2019-002160. Epub 2020 Mar 5.

  PMID: 32139358 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood; Urine

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lesley Colvin, PhDFRCA FRCP

  NHS Lothian/ University of Edinburgh

  PRINCIPAL INVESTIGATOR

• Marie Fallon, MD FRCP

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 2, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)