Effects of Chocolate Consumption in Elderly Patients With Cancer in Palliative Care
Condition: Nutrition Related Cancer; Aging
Study type: Interventional

Summary: 
      Elderly patients with advanced cancer stage constitute an important demand for palliative
      care, a scenario in which metabolic and nutritional status changes may be present.

      The aim of this study was to evaluate the effects of chocolate consumption for 4 continuous
      weeks on nutritional status, quality of life, body composition, oxidative stress and
      inflammatory activity of elderly cancer patients in palliative care.
    

Detailed description: 
      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.
    

Intervention name(s): Chocolate
Intervention type(s): Dietary Supplement
Intervention description(s): 25 g of chocolate by day for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparative, randomized, non-blind intervention study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Palliative Care; Aging