Randomized control trialsRandomized trial of the effects of individual nutritional counseling in cancer patients☆
Introduction
Malnutrition occurs frequently in cancer patients during and after radio- and/or chemotherapy for upper gastrointestinal cancer.1 Malnutrition is associated with excess morbidity and mortality,2, 3 increased risk of complications, prolonged length of stay (LOS) in the hospital,3, 4 reduced response to treatment and reduced quality of life (QoL).5
Patients with upper gastrointestinal cancers have the highest risk of developing cachexia.6 Weight loss is a component in this syndrome in addition to increased muscle protein degradation, inflammation, insulin resistance, anemia, and anorexia.7, 8, 9 Cancer cachexia causes mobilization of proteins and lipids due to increased production of pro-inflammatory cytokines, including interleukin-1 (IL-1), interleukin-6 (IL-6) and tumor necrotizing factor alpha (TNF-α).7 The condition causes increased morbidity and mortality in patients with advanced cancer.7, 9
In a randomized controlled trial Isenring et al.10 found, that patients treated with radiotherapy directed against the abdominal or pelvic areas did significantly better during therapy on variables such as weight loss, nutritional status and quality of life when receiving early nutritional counseling, than did patients receiving standard information and a booklet about possible nutritional problems.
Similar results were found by Ravasco et al.,11 who included 111 colorectal cancer outpatients referred for radiotherapy. Nutritional counseling resulted in significant improvements in energy and protein intake, and every QoL function score improved proportionally to the intake. Furthermore the symptom incidence and severity were decreased in the counseled group. However, the control group received no support at all. We wanted to investigate if these findings could be reproduced with a control group treated according to our national standards, and whether eicosapentaenoic acid (EPA) has beneficial effects as shown in patients with other types of cancer.12
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Materials and methods
The prospective, randomized controlled unblinded study was conducted with 61 consecutive outpatients accepting to participate. The study was conducted in accordance with the Declaration of Helsinki and the protocol was approved and registered by The Local Committee (Capital Region) on Health Research Ethics (No. H-4-2009-135), ClinicalTrials No. NCT01962272.
The study included 61 outpatients (Table 1). Patients were recruited between January 2010 and May 2010. Patients included were referred to
Results
Of the 61 patients randomized three patients from the counseled group were excluded or died during the treatment period, whereas all control patients completed the treatment. After three months, 24 counseled patients participated in the follow-up study as four patients had died and one was lost to follow-up. Twenty-eight patients from the control group participated in the follow-up study as one had died (Fig. 1).
The two study groups were comparable at baseline, judged by diagnosis, age, gender,
Discussion
The results of the present study demonstrate that intensive, individual dietary counseling has a positive effect on weight maintenance of cancer patients' during the treatment period, but this effect does not persist after the end of the intervention. Furthermore, the intervention had a positive effect on the fulfillment of patients' energy and protein requirements, and the effect on the fulfillment of protein requirements lasted three months after the intervention. However, the intervention
Conclusions
Individual dietary counseling had a beneficial effect in the treatment of cancer, but it is debatable whether the effect is reasonably related to the use of resources and side effects. Our finding of beneficial effects of fish oil are observational as compliance was modest, but deserves exploration in a randomized trial with specific focus on the compliance problem.
Conflicts of interest or disclaimers
No conflicts of interest or disclaimers. All authors participated in the design and writing of the manuscript. Data was collected by GMP and LLP, who did the analyses together with JRA. All authors read and approved the final manuscript. Nutricia A/S is acknowledged for supplementing Forticare®.
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Presented as a poster at the 33rd ESPEN Congress, Göteborg, 3-6/9-11.