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The Effect of Special Diets in Hematological Cancer Patients

NCT02880709 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-08-29

No results posted yet for this study

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.

Conditions

  • Hematological Malignancy

Interventions

DIETARY_SUPPLEMENT

Special diet

Tate and energy content adjusted with spices to obtain maximal intake

Sponsors & Collaborators

  • Jens Rikardt Andersen

    lead OTHER

Principal Investigators

  • Jens Rikardt Andersen, MD,MPA · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-05-31
Completion
2014-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02880709 on ClinicalTrials.gov