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

U

University of Sao Paulo

Status

Completed

Conditions

Aging
Nutrition Related Cancer

Treatments

Dietary Supplement: Chocolate

Study type

Interventional

Funder types

Other

Identifiers

NCT04367493
1690/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

60 to 83 years old

Volunteers

No Healthy Volunteers

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%

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 3 patient groups

1. Group 55% cocoa intervention
Experimental group
Description:
55% cocoa intervention
Treatment:
Dietary Supplement: Chocolate
2. Group White Chocolate
Experimental group
Description:
White chocolate
Treatment:
Dietary Supplement: Chocolate
3. Control Group
No Intervention group
Description:
Control Group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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