Randomised Trial of the Effects of Individual Nutritional Counseling in Cancer Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Accumulated weight-change in per cent
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Forticare®. (Dietary Supplement)
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.
Intervention: Weekly nutritional counseling (Behavioral)
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.
Intervention: Weekly nutritional counseling (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- Treatment related side effects and Quality of Life(up to 7.5 weeks)
Investigators
Jens Rikardt Andersen
Associate Professor, Senior Physician
University of Copenhagen