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The Effect of Nutritional Counseling for Cancer Patients

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ClinicalTrials.gov Identifier: NCT01962272
Recruitment Status : Completed
First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Information provided by (Responsible Party):
Jens Rikardt Andersen, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Uterine Cancer Behavioral: Weekly nutritional counseling Dietary Supplement: Forticare®. Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomised Trial of the Effects of Individual Nutritional Counseling in Cancer Patients
Study Start Date : January 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutritional counseling and Forticare®
Weekly 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.
Behavioral: Weekly nutritional counseling
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®.

Dietary Supplement: Forticare®.
Active Comparator: Control

The 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.

Behavioral: Weekly nutritional counseling
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®.




Primary Outcome Measures :
  1. Accumulated weight-change in per cent [ Time Frame: up to 7.5 weeks ]
    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.


Secondary Outcome Measures :
  1. Treatment related side effects and Quality of Life [ Time Frame: up to 7.5 weeks ]
    Secondary endpoints were treatment related side effects and Quality of Life.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult, consecutive outpatients referred for either palliative or preoperative chemotherapy and/or radiation therapy of cancers in the stomach or the pelvic area.

Exclusion Criteria:

  • Lack of ability to understand danish language and the instructions given

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962272


Locations
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Denmark
Departmen of Oncology, Rigshospital
Copenhagen, Denmark, 2100 OE
Sponsors and Collaborators
University of Copenhagen
Investigators
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Principal Investigator: Jens R Andersen, MD,MPA University of Copenhagen

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Responsible Party: Jens Rikardt Andersen, Associate Professor, Senior Physician, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01962272     History of Changes
Other Study ID Numbers: H-4-2009-135
H-4-2009-135 ( Registry Identifier: Regional Ethics Commitee )
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013

Keywords provided by Jens Rikardt Andersen, University of Copenhagen:
cancer
radiotherapy
chemotherapy
nutrition
dietary counseling
quality of life

Additional relevant MeSH terms:
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Esophageal Neoplasms
Uterine Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female