Clinical trial NCT04367493: Effects of Chocolate Consumption in Elderly Patients With Cancer in Palliative Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Related Cancer
Aging
Keywords: Palliative Care
Aging
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative, randomized, non-blind intervention study
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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%

Primary outcomes:
measure: Change in Nutritional Status
timeFrame: 4 weeks
measure: Change in Food Ingestion
timeFrame: 4 weeks
measure: Change in Body Composition
timeFrame: 4 weeks
measure: Change in Level of Quality of Life
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in the measurements of oxidative stress
timeFrame: 4 weeks
measure: Change in inflammatory status
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.