The Effect of Nutritional Counseling for Cancer Patients
Randomised Trial of the Effects of Individual Nutritional Counseling in Cancer Patients
1 other identifier
interventional
61
1 country
1
Brief Summary
Background and aims: Cancer-related malnutrition is multifactorial and related to a bad prognosis. The aim of this study was to investigate the effect of intensive, individual dietary counseling of patients in radiotherapy and/or chemotherapy for gynecologic-, gastric-, or esophageal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 8, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2013
CompletedOctober 14, 2013
October 1, 2013
4 months
October 8, 2013
October 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accumulated weight-change in per cent
The primary end-points were accumulated weight-loss or -gain in per cent of the weight measured between inclusion and end of treatment and between end of treatment and follow-up, respectively.
up to 7.5 weeks
Secondary Outcomes (1)
Treatment related side effects and Quality of Life
up to 7.5 weeks
Study Arms (2)
Nutritional counseling and Forticare®
EXPERIMENTALWeekly nutritional counseling and Forticare®. The goal being an intake that met the protein and energy requirements according to Harris-Benedict equation multiplied with an individual activity factor (1,1-1,5) and a stress factor (1,0-1,1). Daily protein requirements were estimated to 1,5 g/kg per day. In addition to the counseling, the patients in the intervention group were offered a high-protein nutrition supplement containing n-3 fatty acids (Forticare®, Nutricia). The recommended daily dose contained 2531 kJ, 33.8 g protein and 2.2 g EPA.
Control
ACTIVE COMPARATORThe control group was nutritionally instructed by the nurses with the possibility to call for a dietician not related to the study if needed. No fixed schemes. Apart from the nutritional element the patients had the same care and therapy, including treatment of pain and side-effects to the treatment.
Interventions
The counseling included assessment of food intake, advice about improvement, motivation and specific food plans, as well as motivation to comply to the recommended dose of Forticare®.
Eligibility Criteria
You may qualify if:
- Adult, consecutive outpatients referred for either palliative or preoperative chemotherapy and/or radiation therapy of cancers in the stomach or the pelvic area.
You may not qualify if:
- Lack of ability to understand danish language and the instructions given
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Departmen of Oncology, Rigshospital
Copenhagen, 2100 OE, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens R Andersen, MD,MPA
University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Senior Physician
Study Record Dates
First Submitted
October 8, 2013
First Posted
October 14, 2013
Study Start
January 1, 2010
Primary Completion
May 1, 2010
Study Completion
September 1, 2010
Last Updated
October 14, 2013
Record last verified: 2013-10