Nutrition Related CancerNCT04367493
Effects of Chocolate Consumption in Elderly Patients With Cancer in Palliative Care
A study testing Chocolate in people with Nutrition Related Cancer and Aging, run by University of Sao Paulo.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 83 years
- Conditions the study is for
- Nutrition Related Cancer, Aging
- What is being tested?
- Chocolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2016to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients with cancer and palliative care in outpatient follow-up, with Karnofsky Palliative Scale (KPS) of 60% or more
Who cannot join
- Karnofsky Palliative Scale (KPS) of less than 60%
About this study
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
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.
Read the 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.
- Conditions
- Nutrition Related Cancer, Aging
- Being tested
- Chocolate
- Keywords
- Palliative Care, Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChocolateDietary supplement
25 g of chocolate by day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1. Group 55% cocoa intervention | Experimental | 55% cocoa intervention Receives: Dietary Supplement: Chocolate |
| 2. Group White Chocolate | Experimental | White chocolate Receives: Dietary Supplement: Chocolate |
| 3. Control Group | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Change in Body Composition
Body composition was evaluated by the deuterium oxide method at the basal moment and after 4 weeks.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start15 Apr 2016
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition Related CancerStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative, randomized, non-blind intervention study
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nereida Kilza da Costa Lima, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367493
- Sponsor's protocol ID
- 1690/2015
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34980096
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04367493
- Acronym / sponsor ID
- 1690/2015
- Conditions
- Nutrition Related Cancer, Aging
- Keywords
- Palliative Care, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Comparative, randomized, non-blind intervention study
| Arm | Type | Receives |
|---|---|---|
| 1. Group 55% cocoa intervention | Experimental | Dietary Supplement: Chocolate55% cocoa intervention |
| 2. Group White Chocolate | Experimental | Dietary Supplement: ChocolateWhite chocolate |
| 3. Control Group | No intervention | –Control Group |
Who may qualify
- Ages
- 60 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elderly patients with cancer and palliative care in outpatient follow-up, with Karnofsky Palliative Scale (KPS) of 60% or more
Key exclusion criteria (1 listed)
- Karnofsky Palliative Scale (KPS) of less than 60%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chocolate25 g of chocolate by day for 4 weeks | Dietary supplement | 1. Group 55% cocoa intervention, 2. Group White Chocolate |
Primary outcome
Change in Nutritional Status
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 weeks
The European Organization for Cancer Research and Treatment Questionnaire was administered before and after the intervention of 4 weeks.
2 secondary outcomes
Change in the measurements of oxidative stress
Time frame: 4 weeks
Change in inflammatory status
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Derived from this study: PubMed 34980096Vettori 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Chocolate in people with Nutrition Related Cancer and Aging, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nutritional Status (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04367493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.