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.
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
- Conditions the study is for
- Cancer Induced Bone Pain, Secondary Malignant Neoplasm of Bone, Toxicity Due to Radiotherapy
- 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.
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.
- Conditions
- Cancer Induced Bone Pain, Secondary Malignant Neoplasm of Bone, Toxicity Due to Radiotherapy, Pain
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Clinical biomarker (thermal sensory testing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted2 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer Induced Bone PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Lesley Colvin, PhDFRCA FRCP, Principal investigator, NHS Lothian/ University of EdinburghMarie Fallon, MD FRCP, Principal investigator, University of Edinburgh
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 20680354Delaney 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 18492671Parker 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02887833
- Acronym / sponsor ID
- TiBoP / 16/SC/0260
- Conditions
- Cancer Induced Bone Pain, Secondary Malignant Neoplasm of Bone, Toxicity Due to Radiotherapy, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XRT for Cancer induced bone pain | – | Other: Clinical biomarker (thermal sensory testing)Will have community based assessment before and after radiotherapy to assess feasibility of using a clinical biomarker (thermal sensory testing) to predict treatment response |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer induced bone pain scheduled to undergo palliative radiotherapy for this
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- • they are confused or suffering from significant psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | XRT for Cancer induced bone pain |
Primary outcome
Sensitivity and specificity of the thermal sensitivity score in CIBP with respect to experiencing a "positive outcome" after XRT
Time frame: 6 weeks
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.
2 secondary outcomes
Sensitivity and specificity of thermal testing with respect to experiencing a positive outcome
Time frame: 12 weeks
Change in validated self report measures of the pain experience
Time frame: 2,6,12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Background: PubMed 20680354Laird 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.
- Background: PubMed 18492671Delaney 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.
- Results publication: PubMed 32139358Parker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesley Colvin, PhDFRCA FRCP principal investigator
NHS Lothian/ University of Edinburgh
Marie Fallon, MD FRCP principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
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.