Fallon, M., Hoskin, P.J., Colvin, L.A., Fleetwood-Walker, S.M., Adamson, D., Byrne, A., . . . Laird, B.J. (2016). Randomized double-blind trial of pregabalin versus placebo in conjunction with palliative radiotherapy for cancer-induced bone pain. Journal of Clinical Oncology, 34, 550–556. 

To determine the effectiveness of pregabalin in conjunction with radiotherapy to treat patients with cancer-induced bone pain (CIBP)

This double-blind randomized study examined the concurrent use of pregabalin with palliative radiotherapy (versus placebo with radiotherapy) to prove the efficacy of use for treatment of CIBP. Patients were given 75 mg pregabalin or placebo twice daily for 35 days. Assessment of analgesia was done every seven days from baseline. If adequate analgesia was not achieved, trial medication was increased incrementally up to 300 mg twice daily. Radiotherapy was given in either one fraction of 8 GY or 20 Gy in five fractions.

• N = 233   
• AGE:18 years or older; more than 95% of participants were 45 years or older
• MALES: 50.9% pregabalin, 60.7% placebo; FEMALES: 49.1% pregabalin, 39.3% placebo
• CURRENT TREATMENT: Radiation 
• KEY DISEASE CHARACTERISTICS: Those with radiologically proven bone metastases who were scheduled to receive radiotherapy as pain treatment and who had pain scores equal to or greater than 4 on the 0–10 pain scale
• OTHER KEY SAMPLE CHARACTERISTICS: Participants had a life expectancy greater than two months, one or more sites of CIBP being treated with radiotherapy, the ability to provide informed consent to participate in the trial, and did not currently use gabapentin and/or pregabalin in therapeutic regimen (in other words, participation in this study would be the introduction of pregabalin in those participants, not in the placebo arm). Patients who had any change in cancer treatment therapy before entering the study (with the potential to influence pain perception) were excluded.

• SITE: Multicenter
• SETTING TYPE: Outpatient
• LOCATION: Five cancer centers in the UK

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care 

• Multicenter, double-blinded randomized trial

• 0-10 Numeric Rating Scale
• Brief Pain Inventory (BPI) for worst pain and pain interference
• Hospital Anxiety and Depression Scale (HADS)

No statistically significant differences in average pain, pain intereference, or quality of life were discovered. However, differences in mood and breakthrough pain duration, which was lesser in the pregabalin arm (p = 0.037), were present.

These findings do not support use of pregabalin in patients with CIBP receiving palliative radiotherapy.

• Optimal dose of pregabalin was not determined prior to the study.
• No subgroup analysis based on fractionation/schedule of radiotherapy
• No information regarding any use of bone-modifying agents

Nurses providing care to patients in the outpatient setting are in prime position to conduct further research to determine the efficacy of adjunct medications and/or other treatment modalities used for treatment of CIBP and chronic cancer pain in general. Nurses may serve as principal investigators or coinvestigators in further research to determine the most effective interventions. Nurses may also serve to make recommendations for Putting Evidence into Practice (PEP) in outpatient cancer treatment settings, and in doing so serve as patient advocates. Findings do not support the use of pregabalin for metastatic bone pain in patients with cancer.