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L-Carnitine Cancer Fatigue ESMO 2010 2012 Key Clinical Evidence for L-carnitine in Cancer Fatigue Mancinelli Carboplatin: ↑carnitines urinary excretion De Greve Decreased carnitine, correlates with fatigue Hockenberry Decreased carnitine, correlates with fatigue Graziano LC reduces fatigue and improves carnitine levels Cruciani LC reduces fatigue, depression and improves sleep and carnitine levels *Vinci Lower plasma carnitines in neoplastic cachectic patients than in neoplastic patients *Gramignano LC reduces fatigue, oxidative stress and improves QoL, BMI *= not included in the selling outlines ESMO 2012 Mancinelli - Low Carnitine levels in carboplatin treated cancer patients Study evaluated the effect of carboplatin treatment on plasma and urine levels of Lcarnitine (LC) and Acetyl-L-Carnitine (ALC) in cancer patients. Patients: 11 patients with various types of cancer. Results: Carboplatin treatment significantly increased urinary excretion of LC and ALC, without affecting plasma levels. ESMO 2012 De Greve - In breast cancer patients treated with anthracycline Study evaluated L-carnitine levels and fatigue in breast cancer patients on anthracycline-based regimens Patients: 12 patients after 6 cycles of chemo + 6 months followup. Results: • Found decreased levels of both free carnitine (-33%) and acyL-carnitine (-22%). • Increased fatigue levels were observed in patients. . Conclusions: Low plasma L-carnitine levels in early breast cancer patients on anthracycline-based chemotherapy could be responsible for the fatigue observed in these patients. ESMO 2012 Hockenberry - Carnitine plasma levels in patients receiving Study examined fatigue and L-carnitine plasma levels in children/adolescents before and after chemotherapy Patients: 67 children and adolescents between 7 and 18 years of age receiving first or second course of cisplatin, doxorubicin or ifosfamide chemotherapy Results: • There was a significant increase in free and total carnitine levels after treatment fot patients receiving doxorubicin than patients receiving cisplatin ir ifosfamide. • Increased fatigue and decreased carnitine levels were significantly correlated a week after chemotherapy in children/adolescents who had received prior chemotherapy. Conclusions: This study provides support for a relationship between carnitine decreased levels and fatigue in children/adolescents with cancer. ESMO 2012 Graziano - Non-anaemic cancer patients Study investigated the efficacy of L-carnitine in the treatment of chemotherapy-induced fatigue in nonanaemic cancer treatments (principally platinum based). Patients: 50 patients, open study Treatment: 1 week oral L-carnitine 2g twice daily + 2 weeks follow-up Results: • After 1 week of treatment with oral L-carnitine 2g bd, all patients achieved normal plasma carnitine levels (> 30 µM) • Fatigue (FACT-F scores) significantly improved in 45/50 (90%) patients (p<0.001) • Fatigue scores remained constant during the two weeks following the suspension of L-carnitine treatment. Conclusions: Study demonstrates the efficacy of oral L-carnitine in the treatment of chemotherapy-induced fatigue in non-anaemic cancer patients ESMO 2012 Cruciani – Advanced cancer patients Dose-finding study to determine the safety and tolerability of oral L-carnitine supplementation in carnitine-deficient patients with advanced cancer. Patients: 27 patients, open label study Treatment: 1 week of various doses of oral L-carnitine solution from 250mg/day to 3g/day Results: • Symptoms of fatigue, depressive mood, quality of sleep, significantly improved in all patients after 1 week of treatment with oral L-carnitine • A dose-response relationship was observed for Fatigue in L-carnitine responders • Oral L-carnitine supplementation is very well tolerated up to dose of 3000mg/day. Conclusions: Phase I/II study shows L-carnitine to be safe, tolerable and effective at reducing fatigue in advanced-cancer patients undergoing chemotherapy ESMO 2012 Vinci - Low Carnitine levels in neoplastic cachectic patients Study investigated carnitine levels in cancer cachectic patients vs healthy controls Patients: 46 neoplastic cachectic patients / 30 neoplastic patients / 30 healthy pts. Results: Serum carnitine levels were lower in neoplastic cachectic patients when compared to neoplastic patients with good nutritional status and healthy controls. Conclusions: Carnitine levels showed to be lower in neoplastic cachectic patients when compared to healthy controls ESMO 2012 Key Clinical Evidence for use of L-carnitine in Cancer Fatigue Study investigates the effect of oral L-carnitine on Fatigue, QOL, Nutritional status in advanced cancer patients Patients: 12 patients Treatment: L-carnitine 6g/day (2g tid) oral, 4 weeks Results: • Fatigue, QoL and nutritional status of patients significantly improved after 4 weeks treatment with 6g / day L-carnitine. • LBM and appetite were also improved. . Conclusions: Study highlights what was previously investigated by Vinci in 2005 on cachectic patients. ESMO 2012 Sezen - L-carnitine significantly reduced brain and retina damage Study evaluated the effect of L-carnitine treatment on brain and retina radiotherapy-induced damage in a rat model Treatment: Animals received treatment 4hrs before irradiation and for 10 days after irradiation) L-carnitine: 200 mg/Kg/d, ip Irradiation: total cranium radiotherapy with cobalt-60 (15Gy, single dose . Conclusions: After 10-days treatment with L-carnitine a significant reduction is observed in: 1) total cranium irradiation-induced brain and retinal damage 2) total cranium irradiation-induced brain oxidative stress ESMO 2012 L-Carnitine Rational in Cancer Therapy Side Effects ESMO 2012 L-Carnitine in Cancer Therapy Side Effects: Selling Outline HOOK You are no doubt aware that cancer therapies may severely affects patients’ quality of life. Fatigue is a commonly reported symptom resulting from chemotherapy, a condition further worsened by chemotherapy-induced carnitine deficiency. MAIN PART Carnitine is an endogenous substance which plays a key role in energy metabolism, and its depletion in cancer patients, is a condition often under diagnosed. ESMO 2012 In 11 cancer patients, Mancinelli showed that …. ESMO 2012 … carboplatin treatment was associated with a marked urinary loss of carnitine. So, the question is: Could carnitine depletion be associated with the symptoms of fatigue in cancer patients? ESMO 2012 De Greve observed 17 early breast cancer patients on anthracycline based chemotherapy. ESMO 2012 This prospective study demonstrates a clinically significant worsening in fatigue symptoms, associated with a decrease of carnitine levels by more than 30%. Therefore, in cancer patients, carnitine depletion secondary to chemotherapy, seems to be associated with fatigue. Why not treat these subjects with L-Carnitine? ESMO 2012 These observations have been recently confirmed by Hockenberry in this study on children/adolescents receiving cisplatin ifosfamide or doxorbucine. ESMO 2012 We can see that there is a free carnitine reduction when the children had already been treated with chemotherapy. ESMO 2012 Equivalent results for the total carnitine plasma levels. Not surprisingly also in this study there was a significant relationship between the reduced carnitine levels and the fatigue. ESMO 2012 A milestone on the potential role of carnitine administration for treating cancer fatigue is the paper by Graziano, involving 50 non-anaemic cancer patients. ESMO 2012 After 1 week of treatment with oral L-carnitine (4g/d), all patients achieved normal plasma carnitine levels, and Fatigue significantly improved in 90% of patients. Moreover, Fatigue scores remained constant during the two weeks following the discontinuation of L-carnitine treatment. ESMO 2012 Chemotherapy-induced fatigue is not the only symptom alleviated by carnitine. Many cancer patients experience radiotherapy-induced organ damage. Preclinical data shed light on the possibility that L-carnitine might alleviate irradiation damage ESMO 2012 Due to its antioxidative properties, L-carnitine significantly reduced brain (look at the reduced number of pyknotic nuclei) …. ESMO 2012 … and retina damage (look at the normalized thickness) So, as you can see, treatment with Lcarnitine by correcting carnitine deficiency and reducing oxidative stress might result beneficial ameliorating cancer patients’ quality of life. ESMO 2012 L-Carnitine in Cancer Therapy Side Effects: Selling Outline OVERALL CONCLUSIONS So, as you can see, treatment with LCarnitine by correcting carnitine deficiency and reducing oxidative stress might result beneficial ameliorating cancer patients’ quality of life. ESMO 2012