The purpose of this study is to determine whether the EGFR-inhibitor cetuximab is better than placebo for the treatment of neuropathic pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Center for Cancer Treatment, Sorlandet Hospital HF
Kristiansand, Norway
Change in average neuropathic pain score using an 11-point numeric rating scale.
Time frame: Days 4-8 after each infusion of cetuximab and placebo
Comparison of frequency, in all patients on active treatment of at least a 30% reduction of average neuropathic pain score using an 11-point numeric rating scale.
Time frame: Days 4-8 after each infusion of cetuximab and placebo
Comparison of frequency in all patients on active treatment of at least a 50% reduction of average neuropathic pain score using an 11-point numeric rating scale.
Time frame: Days 4-8 after each infusion of cetuximab and placebo
Comparison of change in average worst neuropathic pain score using an 11-point numeric rating scale.
Time frame: Days 4-8 after each infusion of cetuximab and placebo
Comparison of frequency, in all patients on active treatment of at least a 30% reduction of average worst neuropathic pain score using an 11-point numeric rating scale.
Time frame: Days 4-8 after each infusion of cetuximab and placebo
Comparison of frequency in all patients on active treatment of at least a 50% reduction of average worst neuropathic pain score using an 11-point numeric rating scale.
Time frame: Days 4-8 after each infusion of cetuximab and placebo
Patient Global Impression of Change.
Time frame: 7 days after each infusion.
Brief Pain Iinventory (short form) interference scores, comparing cetuximab to the placebo.
Time frame: Days 4-8 after each infusion during treatment periods 1 and 2.
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Brief Pain Iinventory (short form) total scores, comparing cetuximab to the placebo.
Time frame: Days 4-8 after each infusion during treatment periods 1 and 2.
2-hourly waking time 11-point numeric rating scale (item #6 from the Brief Pain Inventory) in the first 24 hours and daily thereafter.
Time frame: 2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86).
Number of AE and SAE recording
Time frame: From signing informed consent (within 28 days prior to first study treatment) and until 30 days after the last study infusion.