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A Double-Blind, Placebo-Controlled Randomized Phase IIa Study: Evaluating the Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Solid Cancer Patients.
Chaiworramukkul, A, Seetalarom, K, Saichamchan, S, Prasongsook, N
Asian Pacific journal of cancer prevention : APJCP. 2022;23(7):2333-2340
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Cancer anorexia–cachexia syndrome (CACS) is usually found in advanced cancer patients. CACS is a multifactorial process which comprises skeletal muscle and adipose tissue loss which may be compounded by anorexia and a dysregulated metabolic state. The hypothesis of this study was that curcumin will increase body compositions and body weight in patients with solid malignancy and CACS when compared to placebo after adjusting by age, gender, primary site of cancer, stage of cancer, performance status, and supplementary nutrition support. This study was a double-blind, placebo-controlled randomised phase lla study. A total of 46 patients were enrolled, of whom 33 underwent 1:1 block of four randomisations. Seventeen patients were randomly assigned to receive curcumin at dose of 800 mg twice daily orally and sixteen patients were randomly assigned to received placebo. Results show that curcumin supplementation: (1) did not statistically significantly improve body compositions and body weight when compared to placebo; (2) may cause clinical benefit in term of hand grip muscle strength and slow progress of CACS by decreasing in basal metabolic rate and preventing the decline in serum albumin; and (3) administered orally for two months at a dose of up to 2 grams daily appeared safe and no serious adverse events were reported. Authors conclude that curcumin inhibited process of CACS via reduction of basal metabolic rate and slowed down the progression of hand-grip muscle strength loss. Furthermore, nuclear factor kappa B [regulator of gene expression] levels merit further exploration as potentially suitable predictive biomarker for CACS treatment with curcumin.
Abstract
OBJECTIVE We aim to investigate the effect of curcumin on preventing cancer anorexia-cachexia syndrome (CACS) via through mechanism of inhibition on NF-kB signal pathway. Outcome measurement for primary end point was improvement of body tissue composition, and the secondary end points were body weight and body mass index, hand grip muscle strengthening, and safety. METHODS This is randomized, double-blind, placebo-controlled phase ll a study, 33 patients with CACS in solid malignancy were enrolled and randomized in 1:1 to receive oral curcumin (at a dose of 800 mg twice daily) or placebo for 8 weeks. RESULTS All parameters of body compositions were not statistically significant different between two groups, which were consist body fat mass [-1.25(SEM 0.87) vs. +0.63(SEM 0.55); p=0.119], skeletal muscle mass [-0.35(SEM 0.60) vs.+0.33(SEM 0.42); p=0.408] and percent body fat [-0.47(SEM 0.95) vs. -0.29(SEM 0.82); p=0.893] including with basal metabolic rate [-13.47(SEM 21.94) vs. +15.30(13.76); p=0.336]. The average of weight loss was also not statistically significant different between two groups. [-1.4 kg(SEM 0.89) in curcumin vs-1.12 kg(SEM 0.73), p=0.810]. Notably, patient with curcumin had less reduction of hand-grip muscle strength on both hands [Rt. handed: -2.47 in curcumin vs. -5.36 in placebo; p=0.318] [Lt. handed: -1.98 vs. -5.43; p=0.317], and basal metabolic rate than placebo group. Most adverse events were grade 1 on both groups similarly. CONCLUSION Curcumin was not shown to be superior to placebo with regard to increasing the body composition in cancer patients with CACS. However, curcumin might show some clinical benefits, including slow progression of hand-grip muscle strength loss, and basal metabolic rate. Further investigations should be explored.
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A Randomized Double-Blind, Cross-Over Trial of very Low-Calorie Diet in Overweight Migraine Patients: A Possible Role for Ketones?
Di Lorenzo, C, Pinto, A, Ienca, R, Coppola, G, Sirianni, G, Di Lorenzo, G, Parisi, V, Serrao, M, Spagnoli, A, Vestri, A, et al
Nutrients. 2019;11(8)
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The ketogenic diet (KD) constitutes high-fat, adequate protein, and low-carbohydrate, and has been proven to be efficacious for the treatment of drug-resistant epilepsy. Recently, KD showed promising results for treating other neurological conditions. The aim of this study was to analyse the effects of very low-calorie ketogenic diets (VLCKDs) in overweight episodic migraine patients during a weight-loss intervention. This study is a double-blind cross-over design randomised trial (of five phases). Participants eligible for trial participation were overweight/obese adults, aged 18 to 65 years, who had at least 12 months’ history of migraines with or without aura. Subjects alternated randomly between a very low-calorie ketogenic diet and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. Results indicate that a 4-week period VLCKD, despite inducing similar weight loss and glycaemic profile, was significantly more effective than VLCnKD in preventing migraine attacks, as evidenced by a decrease in the frequency of migraine days and attacks, and a greater than 50% response rate. Authors conclude that VLCKD is effective for rapid, short-term improvement of migraines in overweight patients, while VLCnKD is not.
Abstract
Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. In a nutritional program, 35 overweight obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order (VLCKD-VLCnKD or VLCnKD-VLCD). The primary outcome measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Secondary outcome measures were 50% responder rate for migraine days, reduction of monthly migraine attacks, abortive drug intake and body mass index (BMI) change. Only data from the intention-to-treat cohort (n = 35) will be presented. Patients who dropped out (n = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced -3.73 (95% CI: -5.31, -2.15) migraine days respect to VLCnKD (p < 0.0001). The 50% responder rate for migraine days was 74.28% (26/35 patients) during the VLCKD period, but only 8.57% (3/35 patients) during VLCnKD. Migraine attacks decreased by -3.02 (95% CI: -4.15, -1.88) during VLCKD respect to VLCnKD (p < 0.00001). There were no differences in the change of acute anti-migraine drug consumption (p = 0.112) and BMI (p = 0.354) between the 2 diets. A VLCKD has a preventive effect in overweight episodic migraine patients that appears within 1 month, suggesting that ketogenesis may be a useful therapeutic strategy for migraines.