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Cancer Induced Bone PainTiBoPNCT02887833

Thermal Testing in Bone Pain (TiBoP)

An observational study of Cancer Induced Bone Pain and Secondary Malignant Neoplasm of Bone, run by University of Edinburgh at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Clinical biomarker (thermal sensory testing)
How many people
27 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2016to Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Edinburgh Cancer Centre

    Edinburgh, EH4 2XU

Other trials in United Kingdom

About this study

Official title: An Exploratory Study to Develop and Evaluate a Simple Bedside Tool for Community Use to Identify Who is Most Likely to Benefit From Palliative Radiotherapy for Cancer Induced Bone Pain: Thermal Testing in Bone Pain (TiBoP)

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.

Read the 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.

Being tested
Clinical biomarker (thermal sensory testing)
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02887833
Study groupRoleWhat they receive
XRT for Cancer induced bone painWill have community based assessment before and after radiotherapy to assess feasibility of using a clinical biomarker (thermal sensory testing) to predict treatment response
Receives: Other: Clinical biomarker (thermal sensory testing)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 weeks

Secondary outcomes (2)
  1. Sensitivity and specificity of thermal testing with respect to experiencing a positive outcome

    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.

    Measured: 12 weeks

  2. Change in validated self report measures of the pain experience

    Measured: 2,6,12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02887833
Sponsor's protocol ID
16/SC/0260
Acronym
TiBoP
Status last verified
Jun 2021
First submitted
29 Aug 2016
Last updated
23 Jun 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20680354
  • 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.

    PubMed 18492671
  • 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.

    PubMed 32139358

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer Induced Bone Pain and Secondary Malignant Neoplasm of Bone, run by University of Edinburgh at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and specificity of the thermal sensitivity score in CIBP with respect to experiencing a "positive outcome" after XRT (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02887833, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.

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