Effects of Chocolate Consumption in Elderly Patients With Cancer in Palliative Care
کلید واژه ها
خلاصه
شرح
Clinical trial designed as a comparative, randomized, non-blind intervention study involving elderly patients with cancer and palliative care in outpatient follow-up at the University Hospital of the Ribeirão Preto Medical School - University of São Paulo. Patients were randomized into 3 blocks of 15 subjects in the control (CG), 55% cocoa intervention (GI1) and white chocolate (GI2) intervention groups. The volunteers were evaluated before and after 4 weeks (28 days) for clinical and laboratory nutritional parameters, quality of life analysis and presence and grading of symptoms. The nutritional status of the patients was evaluated using the Mini Nutritional Assessment (MNA) and the current and usual food intake through the 24-hour recall survey (IR24h) and the food frequency questionnaire (FFQ), respectively. The body mass index (BMI), arm circumference and calf circumference of the volunteers were obtained and the body composition was evaluated by the deuterium oxide method. The inflammatory profile was analyzed by serum interleukin 6 levels and the antioxidant capacity was evaluated by the quantification of reduced glutathione (GSH) and ascorbic acid. Serum lipid peroxidation was measured by determining malonaldehyde levels and the presence and quantification of damage to genetic material by 8-hydroxy-2'-deoxyguanosine levels. To analyze quality of life, the European Organization for Cancer Research and Treatment (EORTC) - Quality of Life Questionnaire (QLQ) - C30 was administered and the Edmonton Symptom Assessment System (ESAS) scale was used to assess the frequency and intensity of symptoms. Data were analyzed by SAS Statistical Software (version 9.3; SAS Institute, Inc. Cary, NC) and R Core Team (2016). Initially, a descriptive analysis of the data was performed. Chi-square test was used to evaluate categorical variables. For the comparison between the groups at each moment and between the moments in each group was used linear regression model with mixed effects. The significance level established was <0.05.
تاریخ
آخرین تأیید شده: | 03/31/2020 |
اولین ارسال: | 04/19/2020 |
ثبت نام تخمینی ارسال شد: | 04/23/2020 |
اولین ارسال: | 04/28/2020 |
آخرین بروزرسانی ارسال شده: | 04/23/2020 |
آخرین به روزرسانی ارسال شده: | 04/28/2020 |
تاریخ شروع مطالعه واقعی: | 04/14/2016 |
تاریخ تخمین اولیه اولیه: | 07/29/2019 |
تاریخ برآورد مطالعه: | 07/29/2019 |
شرایط یا بیماری
مداخله / درمان
Dietary Supplement: Chocolate
فاز
گروههای بازو
بازو | مداخله / درمان |
---|---|
Experimental: 1. Group 55% cocoa intervention 55% cocoa intervention | |
Experimental: 2. Group White Chocolate White chocolate | |
No Intervention: 3. Control Group Control Group |
معیارهای صلاحیت
سنین واجد شرایط تحصیل | 60 Years به 60 Years |
جنسیت واجد شرایط مطالعه | All |
داوطلبان سالم را می پذیرد | آره |
شاخص | Inclusion Criteria: - Elderly patients with cancer and palliative care in outpatient follow-up, with Karnofsky Palliative Scale (KPS) of 60% or more Exclusion Criteria: - Karnofsky Palliative Scale (KPS) of less than 60% |
نتیجه
اقدامات اولیه
1. Change in Nutritional Status [4 weeks]
2. Change in Food Ingestion [4 weeks]
3. Change in Body Composition [4 weeks]
4. Change in Level of Quality of Life [4 weeks]
اقدامات ثانویه
1. Change in the measurements of oxidative stress [4 weeks]
2. Change in inflammatory status [4 weeks]