The Effect of Special Diets in Hematological Cancer Patients

NCT02880709 | Completed Phase 4 DMC

• 1 other identifier: Curry
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Malignancy

Outcome Measures

Primary Outcomes (1)

• Weight loss

  30 days

Study Arms (2)

Special diet

EXPERIMENTAL

Special diet with taste, energy-and protein content adjusted according to previous finding

Dietary Supplement: Special diet

Usual diet

NO INTERVENTION

Patients habitual diet

Interventions

Special diet DIETARY_SUPPLEMENT

Tate and energy content adjusted with spices to obtain maximal intake

Special diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hematological cancer
• Ongoing chemotherapy
• Ability to eat by mouth
• Informed consent

You may not qualify if:

• Lack of the ability to understand the informations given
• Lack of the ability to understand the conditions of the experiment

Sponsors & Collaborators

• Jens Rikardt Andersen: lead

Study Sites (1)

Hematological clinic

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jens Rikardt Andersen, MD,MPA

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, MD, MPA

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: November 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 29, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)