Thermal Testing in Bone Pain (TiBoP)
Condition: Cancer Induced Bone Pain; Secondary Malignant Neoplasm of Bone; Toxicity Due to Radiotherapy; Pain
MeSH terms: Neoplasms; Bone Neoplasms
Study type: Observational

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.
    

Intervention name(s): Clinical biomarker (thermal sensory testing)
Intervention type(s): Other
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with cancer induced bone pain scheduled to undergo palliative radiotherapy for
        this
      
Biospecimen description: 
      Blood; Urine