2077P - A randomized, placebo-controlled trial assessing the efficacy and safety of the combination of superoxide dismutase, alpha lipoic acid, vitamin B12, B1, B2, B6, E, Mg, Zn and a fatty acid for 6 months in the management of chemotherapy induced neuropathic pain

Background

To investigate the efficacy of Superoxide Dismutase (SOD, 70 UI), Palmitoyethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg),vitamins B6 (1.5 mg), B1 (1.1 mg), B12(2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet in managing neuropathic pain due to cancer chemotherapy.

Methods

In this pilot study, 67 age-matched patients with cancer (41 men) and a mean age of 65.4 years were randomly assigned, either to receive the combination of ten elements (2 tablets/24h) in the active A group, (n=33), or the placebo B (n=34) for six months. Nerve function was assessed by DPN Check [sural nerve conduction velocity (SNCV) and amplitude (SNAP)]. Sudomotor function was evaluated with SUDOSCAN, which measures electRochemical skin conductance in hands and feet (ESCH and ESCF). We used Pain questionnaires: Pain Detect (PD), Neuropathic Pain Symptom Inventory (NPSI), and Visual Analog Scale (VAS) for the estimation of neuropathic pain, also. All patients received Taxanes and platinum analogs as cancer chemotherapy.

Results

At follow-up, measurements from SNCV, SNAP, ESCH and ESCF did not change significantly in both groups. In A group PD baseline vs. final (9.57±7.0 vs. 6.78±4.16, p=0.003), NPSI (28.51±21.26 vs. 19.87±12.6, p<0.001) and VAS (27.78±22.40 vs 21.48±17.79, p=0.003) improved significantly during follow up. In group B PD (7.03±5.19 vs. 9.71±6.61 p<0.001), NPSI (23.50±18.99 vs. 36.25±22.15, p<0.001), and VAS (25.03±23.83 vs 38.75±26.60 p<0.001) deteriorated. No side effects detected.

Conclusions

The combination of the ten elements as supplement in one tablet for six months at a daily dose of two pills in patients improved neuropathic pain due to cancer chemotherapy.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.