Effects of Chocolate Consumption in Elderly Patients With Cancer in Palliative Care
1 other identifier
interventional
45
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2019
CompletedFirst Submitted
Initial submission to the registry
April 20, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedApril 29, 2020
April 1, 2020
3.3 years
April 20, 2020
April 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
Change in the measurements of oxidative stress
4 weeks
Change in inflammatory status
4 weeks
Study Arms (3)
1. Group 55% cocoa intervention
EXPERIMENTAL55% cocoa intervention
2. Group White Chocolate
EXPERIMENTALWhite chocolate
3. Control Group
NO INTERVENTIONControl Group
Interventions
25 g of chocolate by day for 4 weeks
Eligibility Criteria
You may qualify if:
- Elderly patients with cancer and palliative care in outpatient follow-up, with Karnofsky Palliative Scale (KPS) of 60% or more
You may not qualify if:
- Karnofsky Palliative Scale (KPS) of less than 60%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 34980096DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 20, 2020
First Posted
April 29, 2020
Study Start
April 15, 2016
Primary Completion
July 30, 2019
Study Completion
July 30, 2019
Last Updated
April 29, 2020
Record last verified: 2020-04