Tramadol in the Treatment of Neuropathic Cancer Pain

Daniel Arbaiza; Oscar Vidal

Clin Drug Invest. 2007;27(1):75-83.

Abstract and Introduction

Abstract

Objective: To assess the efficacy, safety and impact on quality of life of tramadol in the treatment of neuropathic pain in patients with cancer.
Methods: Patients with similar characteristics were grouped in pairs and randomised to receive either tramadol or placebo. The initial tramadol dosage was 1 mg/kg every 6 hours, increasing to 1.5 mg/kg every 6 hours if necessary to control pain.
Results: The study enrolled 36 patients (22 women, 14 men), with a mean age of 50 years. In the group receiving tramadol (n = 18), major improvements in pain intensity and Karnofsky scores occurred (p < 0.001), sleep quality improved by day 45 (p < 0.05) activities of daily living improved (p < 0.05), and use of analgesics that had been taken before the study was reduced (p < 0.05) compared with the placebo group. There was no difference between the groups with regard to changes in the Zung Depression Scale, Beck Anxiety Inventory scores and neurophysiological assessments. More patients in the tramadol group experienced adverse events (p < 0.05). The most common adverse events were nausea, vomiting and constipation.
Conclusions: Tramadol is a therapeutic option for the control of neuropathic pain in patients with cancer, and appears to improve quality of life in these patients. The analgesic effect of tramadol is independent of changes in anxiety, depression and nervous system function.

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Table 1. Patient Demographics at Baseline
Variable	Placebo (n=18)	Tramadol (n=18)	p-Value
Mean age (y)	50.50	49.22	NS
Sex (female/male)	12/6	10/8	NS
Mean weight (kg)	59.13	60.77	NS
Mean height (cm)	151.94	152.66	NS
Histology (solid/haematological)	11/7	9/9	NS
Clinical stage IV	8	6	NS
Disease activity^a	9	8	NS
Mean duration of pain (days)	142.66	111.66	NS
Changes in pain over time (constant pain)	6	8	NS
Mean pain intensity (scale 0-10)	7.2	6.8	NS
Pain intensity >6 on scale 0-10	12	10	NS
Changes in sleep quality as a result of pain	12	16	NS
Changes in appetite as a result of pain	6	4	NS
Changes in physical activity as a result of pain	14	16	NS
Mean Karnofsky score (scale 10-100)	70.55	74.44	NS
Karnofsky score >60 on scale 10-100	13	15	NS
Abnormal results on Beck Anxiety Inventory	3	1	NS
Abnormal results on Zung Depression Scale	2	0	NS
Abnormal results on neurophysiological testing	4	4	NS
Use of antiepileptic analgesics before the study	14	12	NS
Average number of drops each 6 hours	25.4	27.5	NS

^aClinical or radiographic evidence of cancer progression.
NS = not significant.

Table 2. Clinical Pain Syndromes at Baseline
Main diagnosis	Placebo (n=18)	Tramadol (n=18)	Total (n=36)
Tumour-related plexuspathy^a	5	5	10
Pain syndrome following surgery^b	4	4	8
Chemotherapy-induced neuropathy^c	3	3	6
Tumour-related epidural compression	3	3	6
Entrapment of peripheral nerve by tumour mass^d	2	2	4
Pain following herpes zoster	1	1	2

^a Three patients with brachial plexuspathy and two with lumbosacral plexuspathy in each group.
^b Three patients with post-mastectomy pain and one patient with post-thoracotomy pain in each group.
^c Two patients taking vincristine and one taking cisplatin in each group.
^d Both patients had a tumour in the humerus that altered the function of the median nerve.

Table 3. Serious Limitations in Activities of Daily Living (ADL) at Days 0, 15, 30 and 45: Tramadol vs Placebo Recipients
Day of Assessment	Placebo		Tramadol		p-Value
Day of Assessment	n	%	n	%	p-Value
Day 0	14/18	78	16/18	89	NS
Day 15	14/18	78	7/18	39	0.018
Day 30	12/18	67	6/18	33	0.046
Day 45	10/12	83	4/13	31	0.008

n = number of patients with serious limitations in ADL/number of evaluated patients; NS = not significant; % = percentage of patients with serious limitations in ADL.

Table 4. Changes in Sleep Quality as a Result of Pain at Days 0, 15, 30 and 45: Tramadol Vs Placebo Recipients
Day of assessment	Placebo		Tramadol		p-Value
Day of assessment	n	%	n	%	p-Value
Day 0	12/18	67	16/18	89	NS
Day 15	12/18	67	8/18	44	NS
Day 30	10/18	56	6/18	33	NS
Day 45	8/12	67	3/13	23	0.028

n = number of patients with changes in sleep quality/number of evaluated patients NS = not significant; % = percentage of patients with changes in sleep quality.

Table 5. Adverse Events at Days 15, 30 and 45 for Tramadol Vs Placebo Recipients
Day of assessment	Placebo			Tramadol			p-Value
Day of assessment	n	%	t	n	%	t	p-Value
Day 15	4/18	22	25	12/18	67	3	0.007
Day 30	4/18	22	13	10/18	56	2	0.040
Day 45	0/12	0	0	7/13	54	0	0.003

n = number of patients with adverse events/number of evaluated patients t = total number of adverse events (some patients had more than one adverse event) % = percentage of patients who experienced an adverse event.

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