The Effect of Special Diets in Hematological Cancer Patients
Primary Purpose
Hematological Malignancy
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Special diet
Sponsored by
About this trial
This is an interventional supportive care trial for Hematological Malignancy
Eligibility Criteria
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
Sites / Locations
- Hematological clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Special diet
Usual diet
Arm Description
Special diet with taste, energy-and protein content adjusted according to previous finding
Patients habitual diet
Outcomes
Primary Outcome Measures
Weight loss
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02880709
Brief Title
The Effect of Special Diets in Hematological Cancer Patients
Official Title
The Effect of Special Diets on Weight and Nutritional Intake in Haematological Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Rikardt Andersen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Major weight loss and taste changes are well documented in patients with hematological cancer during chemotherapy. It has previously been documented, that such patients have preferences for much umami, a little sweet, sour and salt, and no bitter. The purpose of the study was to convert these results into real diets. Patients participated in two sensory pilot studies (n=10), where dishes were tested for preferences before and after chemotherapy. From these results four dishes were selected and tested on 32 patients in 30 days in a cross-over design. The diets resulted in a beneficial and statistical significant difference in weight development (p= 0.0008), with 1.2 ± 1.9 kg (+2%) in the intervention period and -2.8 ± 5.2 kg (-4%) in the control period. This difference persisted after sensitivity analysis (± 10%) p= 0.005. However, the nutritional intake was still low in both periods, and the treatment with cytarabin turned out to be a major confounder as dosage was significantly higher in the control period.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Special diet
Arm Type
Experimental
Arm Description
Special diet with taste, energy-and protein content adjusted according to previous finding
Arm Title
Usual diet
Arm Type
No Intervention
Arm Description
Patients habitual diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Special diet
Intervention Description
Tate and energy content adjusted with spices to obtain maximal intake
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Rikardt Andersen, MD,MPA
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematological clinic
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Special Diets in Hematological Cancer Patients
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