Effects of Chocolate Consumption in Elderly Patients With Cancer in Palliative Care
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1. Group 55% cocoa intervention 55% cocoa intervention |
Dietary Supplement: Chocolate
25 g of chocolate by day for 4 weeks
|
| Experimental: 2. Group White Chocolate White chocolate |
Dietary Supplement: Chocolate
25 g of chocolate by day for 4 weeks
|
| No Intervention: 3. Control Group Control Group |
Outcome Measures
Primary Outcome Measures
- Change in Nutritional Status [4 weeks]
Evaluation by Mini Nutritional Assessment, by the 24-hour Recall Survey, and by the Food Frequency Questionnaire at the basal moment and after 4 weeks of intervention.
- Change in Food Ingestion [4 weeks]
Evaluation of ingestion by the 24-hour Recall Survey and by the Food Frequency Questionnaire at the basal moment and after 4 weeks of intervention.
- Change in Body Composition [4 weeks]
Body composition was evaluated by the deuterium oxide method at the basal moment and after 4 weeks.
- Change in Level of Quality of Life [4 weeks]
The European Organization for Cancer Research and Treatment Questionnaire was administered before and after the intervention of 4 weeks.
Secondary Outcome Measures
- Change in the measurements of oxidative stress [4 weeks]
The antioxidant capacity was evaluated by the quantification of reduced glutathione 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. All measurements were performed before and after 4 weeks of intervention.
- Change in inflammatory status [4 weeks]
Inflammatory status was evaluated by serum Interleukin 6 levels and C Reactive Protein evaluated before and after the intervention.
Eligibility Criteria
Criteria
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%
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Sao Paulo
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1690/2015