The Effect of Nutritional Counseling for Cancer Patients

Gastric Cancer Clinical Trial

Official title:

Randomised Trial of the Effects of Individual Nutritional Counseling in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962272
• Other study ID #: H-4-2009-135
• Secondary ID: H-4-2009-135
• Status: Completed
• Phase: Phase 4
• First received: October 8, 2013
• Last updated: October 11, 2013
• Start date: January 2010
• Est. completion date: September 2010

Study information

• Verified date: October 2013
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Regional Ethics Committee, Capital Region
• Study type: Interventional

Clinical Trial 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.

Description:

The prospective, randomized controlled unblinded study with 61 consecutive outpatients. All patients were stratified according to primary disease (esophageal-, gastric- or gynecological cancer). Patients were randomised using tin foil-lined sealed envelopes by the authors. The sample size was calculated using 2α = 0.05, 1-β = 0.80, expected Standard Deviation (SD) (weight-loss-%) of 2.24 and the corresponding Minimal Relevant Difference of 1.75.

Due to different diagnoses and treatments, the duration of the participation in the study varied between 5 and 12 weeks (average 7.2 weeks). In all cases follow-up was performed three months after the end of treatment.

All patients randomized to receive nutritional intervention were counseled by the same dietitian at baseline, and once a week during treatment and at follow-up after three months. The goal of the nutritional counseling was 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. Dietary intake was evaluated by 24-hour-recall food questionnaires at baseline, every week, at the end of the study and at follow-up. On the basis of information from the 24-hour recall food questionnaires and supplementary comments patients were counseled on an individual basis with the purpose to minimize nutritional symptoms that may relate to cancer cachexia and the cancer treatment. The main elements of the counseling were to explain the importance of nutrition in relation to the patients present situation, to explain the targets and to agree on specific dietary goals to be fulfilled until the next session.

The control group was nutritionally instructed by the nurses with the possibility to call for a dietician if needed.

Apart from nutrition the patients had the same care and therapy, including treatment of pain and side-effects to the treatment.

The dietary data were coded and analysed for energy and protein content using a computerised version of Danish food composition tables.

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 kiloJoule (kJ), 33.8 g protein and 2.2 g EPA. The use of dietary supplements and compliance with dietary recommendations were monitored weekly by questionnaire, interview and counting of residual containers with supplements. The data collection included recording of anthropometric data including body weight and body composition, biochemical nutritional status, nutritional status according to The Nutrition Risk Screening (NRS), and 24-hour dietary interview.

All participants were weighed at baseline, every week, at the end of the study and at follow-up. For a more detailed analysis of the weight development, Bioelectrical Impedance Analysis (BIA) was applied to assess the body composition of each patient. Measurements were performed by the investigators using an ElectroFluidGraph with a current (I) of 330 micro ampere (μA) and a frequency of 50 kilo herz (KHz) and according to Kyle and colleagues.

Quality of life (QoL) was measured at baseline, at the end of the study and at follow-up by using a self-administered questionnaire European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 version 3.0. This instrument is a 30- item cancer specific questionnaire designed to measure cancer patients' physical, psychological and social functions. This questionnaire was chosen because it has been shown to be reliable and valid in a number of studies. The questionnaire includes six function scales (physical, emotional, cognitive, social, role and global health), three symptom scales (fatigue, pain, nausea, or vomiting) and six single items assessing symptoms and the financial impact of the disease. A questionnaire developed in a previous study was used to assess treatment related side effects at the end of treatment by each patient. The questions covered the categories diarrhea, nausea, vomiting, loss of appetite, flatulence, abdominal pain and other kinds of pain.

The micronutrient status of the patients was assessed by blood analysis. The blood samples were obtained at baseline, at the end of treatment and at follow-up (p-Hemoglobin, p-Cobalamin, p-Ferritin, p-Transferrin, p-Iron, p-Magnesium, p-Phosphate, p-Albumin, p- Zinc).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Uterine Cancer
• Uterine Neoplasms

Intervention

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®.

Locations

Country	Name	City	State
Denmark	Departmen of Oncology, Rigshospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Treatment related side effects and Quality of Life	Secondary endpoints were treatment related side effects and Quality of Life.	up to 7.5 weeks	Yes