- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02880709
The Effect of Special Diets in Hematological Cancer Patients
The Effect of Special Diets on Weight and Nutritional Intake in Haematological Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was approved by the regional scientific ethical committee, and was registered in ClinicalTrial.gov NTC no………...
Patients were selected consecutively with acute and chronic leukemia and lymphoma, Hodg-kin's lymphoma, and Non-Hodgkin's lymphoma in treatment with chemotherapy.
Eligible patients were aged >18 years, and only patients who were able to com-municate and understand written and oral information and receive food orally were included. The special diets were developed at the Central Kitchen at Rigshospitalet Initially, two single blinded pilot studies of five patients were performed, with the same inclusion and exclusion criteria as the main study. In the first study patients tested 17 dishes with a taste-mix of dominating umami, a little sweet, sour and salt, and no bitter. In the second round six dishes were selected based on the results from the first round. All dishes had a high energy-density, with a protein content of at least 5 g/100 g. Every dish was tested both before and after chemotherapy. Patients rated acceptability on 9-point scales.
The clinical controlled cross-over design with two periods of four weeks, intervention and control, tested four dishes selected after the second pilot study. 32 patients were included in that trial, and they started with their habitual diet as control and then switched to recommendation of introduction of the four dishes selected.
The patients registered their weight every time they were at the hospital. During the intervention period the patients received a recipe booklet with the four dishes and a noted every time they ingested one of these. Compliance measurements were based on this registration. Patients had access to the dishes when in-patients, but they did their own cooking at home. It was possible to buy the similar dishes as pre-prepared meals in the supermarkets. The dishes in the final study were: Chili con Carne, Chicken in Curry, Curry Soup and Pasta Carbonara with added curry.
Data were analyzed with R (version 2.15.3). In histograms used to show the degree of acceptability for the dishes in the pilot studies, answers above 5 were graded as high grade of acceptance. To present descriptive statistics, the results were expressed as mean ± standard deviation (SD), median (interquartile range (IQR)) and range. As the data did not show a normal distribution, Wilcoxon rang-sum tests (paired and unpaired) were used. Analyses were carried out both according to intention-to- treat (ITT) and per-protocol (PP) principles. As many of the data sampled, especially the subjective ones, sensitivity analysis (± 10% correction of the results) were performed.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Copenhagen, Denmark, 2100
- Hematological clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hematological cancer
- Ongoing chemotherapy
- Ability to eat by mouth
- Informed consent
Exclusion Criteria:
- Lack of the ability to understand the informations given
- Lack of the ability to understand the conditions of the experiment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Special diet
Special diet with taste, energy-and protein content adjusted according to previous finding
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Tate and energy content adjusted with spices to obtain maximal intake
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No Intervention: Usual diet
Patients habitual diet
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight loss
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jens Rikardt Andersen, MD,MPA, University of Copenhagen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Curry
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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