We report the outcome of a pilot, open‐label study that tested the potential of lacosamide (200 mg/bi.d) as an effective and safe symptomatic treatment against acute painful oxaliplatin‐induced peripheral neurotoxicity (OXAIPN). Lacosamide was introduced in 18 colorectal cancer patients with evidence of clinically significant acute, painful OXAIPN after infusion of the third course (T1) of oxaliplatin‐based chemotherapy (FOLFOX4) and was maintained until completion of all 12 courses (T4). The OXA‐Neuropathy Questionnaire (OXA‐NQ) was used to record the severity of acute OXAIPN; the PI‐NRS estimated the severity of neuropathic pain, while the chronic OXAIPN was graded with TNSc. The EuroQOL (EQ‐5D) instrument was also applied. The Patient Global Impression of Change (PGIC) scale measured the lacosamide‐attributed perception of change. LCM‐responders were considered those with ≥50% reduction in PI‐NRS and OXA‐NQ scores at T4, compared to T1. Patients experienced on T1 a median number of acute OXAIPN symptoms of 4 and had a median neuropathic pain severity score of 6, which was strongly related to lower quality of life, according to EQ‐VAS (P < .001). At T4, 12 patients (66.7%) were classified as responders. A significant clinical improvement was documented in the severity of acute OXAIPN and neuropathic pain in relation to lacosamide (P < .001) at T4 compared to T1, which was associated with improved EQ‐VAS scores (P < .001). Twelve patients scored PGIC ≥5 (lacosamide‐attributed) at T4. There were no incidences of early drop‐outs for safety reasons. Lacosamide appears to be an effective and well‐tolerated symptomatic treatment against acute, painful OXAIPN.
We investigated whether rechallenge with oxaliplatin (OXA) can worsen the preexisting oxaliplatin-induced peripheral neurotoxicity (OXAIPN) in metastatic colorectal cancer (mCRC) patients. Patients previously treated with OXA, having clinically significant grade 1 or 2 OXAIPN were assessed, after receiving rechallenge with OXA, using the clinical version of the Total Neuropathy Score (TNSc). Peripheral neuropathy was assessed at the end of first OXA exposure and at completion of OXA rechallenge. The first line OXA-based chemotherapy was completed at least 9 months earlier (OXA-free interval). We studied 25 mCRC patients, 14 males and 11 females, with a median age of 63 (35-77) years. After their first exposure to OXA-based chemotherapy, 9 (36%) patients developed grade 1 OXAIPN and 16 patients grade 2 (64%) neurotoxicity. OXA reintroduction with a median of 10 (8-14) cycles led to
BackgroundTo investigate efficacy and safety of a supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in episodic migraine prevention.MethodsAn observational, prospective, real-world study was conducted. After a one-month baseline period, Vivinor® was introduced in 113 Greek patients with episodic migraine who were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BL) and the third month of supplementation (T3). Secondary endpoints included changes in mean intensity of migraine and in days with use of acute migraine medications. Changes in scores of Migraine Disability Assessment questionnaire (MIDAS), Headache Impact Test-6 (HIT-6), Migraine Therapy Assessment questionnaire (MTAQ), MSQ-QOL (Migraine-Specific Quality of life questionnaire), HADS (Hospital Anxiety and Depression Scale) were also evaluated. Those with ≥ 50% reduction in monthly migraine days at T3, compared to BL were considered Vivinor®-responders.ResultsMean number of migraine days was significantly decreased between BL and T3 (9.9 ± 5.0 vs 6.2 ± 4.0; P < 0.001). Likewise, days with peak headache intensity of > 4/10 (8.3 ± 3.8 vs 5.8 ± 4.0; P < 0.001) as well as days using acute headache medications per month (9.8 ± 5.6 vs 7.2 ± 5.4; P < 0.001) were significantly reduced. At final visit, 64 patients (56.6%) were classified as responders. The beneficial effect of Vivinor® supplementation was also associated with significant changes in HIT-6, MIDAS, MTAQ and MSQ-QOL scores between BL and Τ3. There were no safety concerns.ConclusionsVivinor® appears to be an effective and well-tolerated preventive treatment against episodic migraine.Trial registrationNCT04463875, Registered 9 July 2020- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04463875
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