Thermal Testing in Bone Pain (TiBoP)

NCT ID: NCT02887833

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-12-31

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.

Detailed Description

Bone is the third most common site of metastatic disease, after liver and lung, with ~75 per cent of these patients suffering from related pain. Cancer-induced bone pain (CIBP) remains one of the major clinical challenges in palliative care, with a number of possible reasons for this. Bone pain can have a significant impact on physical, psychological and social functioning (and so overall quality of life). The mechanisms of CIBP are complex and may have unique characteristics that are different from neuropathic and inflammatory pain - this has clear implications for managing CIBP effectively. Current gold standard treatment for CIBP is palliative radiotherapy (XRT). Radiotherapy is the current standard treatment for CIBP, although only 55% of patients will achieve adequate analgesia from palliative radiotherapy, and this can take up to 6 weeks to work. There has been considerable interest in how clinical signs and symptoms in pain translate into underlying mechanisms, and how this may be used to direct treatment more effectively. The clinical assessment of somatosensory processing used for neuropathic pain can be extensive, and burdensome for frail patients.

The investigators have developed a modified assessment for use in patients with cancer, that can be used in a hospital setting. The investigators clinical pilot work used detailed phenotyping of CIBP, to try and better understand underlying mechanisms and detect changes in somatosensory processing. The investigators found that changes in temperature sensitivity may predict pain relief from XRT. Following on from this the investigators propose to develop a simple bedside tool, suitable for use in the community, which will potentially identify patients most likely to benefit from radiotherapy.

Development of this tool requires adequate validation and evaluation so that it can be used as an aid to deciding which patients are more likely to benefit from radiotherapy. In those patients unlikely to benefit, early identification would allow use of other symptom control strategies in the community, minimising the burden of unnecessary hospital attendance, and avoiding the acute pain flare that can occur with XRT.

The investigators hypothesis is that alterations in thermal sensitivity will reflect important changes in underlying pain neurobiology that will make that patient more, or less, likely to get effective analgesia from XRT. Assessment of CIBP There have been recommendations suggested for the use of pain measurement tools and methods in clinical practice to try and include the wider aspects of the pain experience (www.immpact.org). In patients with cancer, it is important to minimise any burden from assessment. We have therefore use a very a simple approach to try and capture the important elements of CIBP and its impact. This consists of a number of validated self report questionnaires (see below), plus a measurement of skin sensitivity to warm and cool (40°C, 25°C), as identified from our previous work as potential predictors of treatment response to XRT.

Self report measures include: the Brief Pain Inventory (BPI); The Short-Form McGill Pain Questionnaire (SF-MPQ-2); the Hospital Anxiety & Depression Scale (HADS); the Distress Thermometer; the EORTC health-related quality of life questionnaire for bone metastases.

Patients with CIBP will be assessed prior to XRT, then at 2, 6 and 12 weeks after XRT.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Clinical biomarker (thermal sensory testing)

Intervention Type: 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.

Interventions

Clinical biomarker (thermal sensory testing)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• • 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lesley Colvin, PhDFRCA FRCP

Role: PRINCIPAL_INVESTIGATOR

NHS Lothian/ University of Edinburgh

Marie Fallon, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

Edinburgh Cancer Centre

Edinburgh, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 20680354 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18492671 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32139358 (View on PubMed)

Other Identifiers

16/SC/0260

Identifier Type: -

Identifier Source: org_study_id