Effects of Chocolate Consumption in Elderly Patients With Cancer in Palliative Care

Effects of Chocolate Consumption in the Nutritional State, Quality of Life, Body Composition, Oxidative Stress and Inflammatory Activity in Elderly Patients With Cancer in Palliative Care

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.

Study Overview

• Status: Completed
• Conditions: Aging; Nutrition Related Cancer
• Intervention / Treatment: Dietary supplement: Chocolate

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Nutritional Status	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.	4 weeks
Change in Food Ingestion	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.	4 weeks
Change in Body Composition	Body composition was evaluated by the deuterium oxide method at the basal moment and after 4 weeks.	4 weeks
Change in Level of Quality of Life	The European Organization for Cancer Research and Treatment Questionnaire was administered before and after the intervention of 4 weeks.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the measurements of oxidative stress	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.	4 weeks
Change in inflammatory status	Inflammatory status was evaluated by serum Interleukin 6 levels and C Reactive Protein evaluated before and after the intervention.	4 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• Vettori JC, da-Silva LG, Pfrimer K, Jordao AA, Louzada-Junior P, Moriguti JC, Ferriolli E, Lima NKC. Effect of chocolate on older patients with cancer in palliative care: a randomised controlled study. BMC Palliat Care. 2022 Jan 4;21(1):5. doi: 10.1186/s12904-021-00893-1.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2016
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Aging; Palliative Care
• Other Study ID Numbers: 1690/2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No