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Randomized Controlled Trial
. 2020 May;25(5):e843-e851.
doi: 10.1634/theoncologist.2019-0856. Epub 2020 Mar 25.

Impact on Health-Related Quality of Life of Parenteral Nutrition for Patients with Advanced Cancer Cachexia: Results from a Randomized Controlled Trial

Carole Bouleuc  1 , Amélie Anota  2   3 , Cécile Cornet  1 , Ghislain Grodard  1   4 , Antoine Thiery-Vuillemin  4 , Olivier Dubroeucq  5 , Nathalie Crétineau  6 , Véronique Frasie  7 , Vincent Gamblin  8 , Gisèle Chvetzoff  9 , Laure Favier  10 , Christophe Tournigand  11 , Marie-Christine Grach  12 , Bruno Raynard  13 , Sébastien Salas  14 , Géraldine Capodano  15 , Lionel Pazart  1 , Régis Aubry  1
Affiliations
Randomized Controlled Trial

Impact on Health-Related Quality of Life of Parenteral Nutrition for Patients with Advanced Cancer Cachexia: Results from a Randomized Controlled Trial

Carole Bouleuc et al. Oncologist. 2020 May.

Abstract

Background: Malnutrition worsens health-related quality of life (HRQoL) and the prognosis of patients with advanced cancer. This study aimed to assess the clinical benefits of parenteral nutrition (PN) over oral feeding (OF) for patients with advanced cancer cachexia and without intestinal impairment.

Material and methods: In this prospective multicentric randomized controlled study, patients with advanced cancer and malnutrition were randomly assigned to optimized nutritional care with or without supplemental PN. Zelen's method was used for randomization to facilitate inclusions. Nutritional and performance status and HRQoL using the European Organization for Research and Treatment of Cancer QLQ-C15-PAL questionnaire were evaluated at baseline and monthly until death. Primary endpoint was HRQoL deterioration-free survival (DFS) defined as a definitive deterioration of ≥10 points compared with baseline, or death.

Results: Among the 148 randomized patients, 48 patients were in the experimental arm with PN, 63 patients were in the control arm with OF only, and 37 patients were not included because of early withdrawal or refused consent. In an intent to treat analysis, there was no difference in HRQoL DFS between the PN arm or OF arm for the three targeted dimensions: global health (hazard ratio [HR], 1.31; 95% confidence interval [CI], 0.88-1.94; p = .18), physical functioning (HR, 1.58; 95% CI, 1.06-2.35; p = .024), and fatigue (HR, 1.19; 95% CI, 0.80-1.77; p = .40); there was a negative trend for overall survival among patients in the PN arm. In as treated analysis, serious adverse events (mainly infectious) were more frequent in the PN arm than in the OF arm (p = .01).

Conclusion: PN improved neither HRQoL nor survival and induced more serious adverse events than OF among patients with advanced cancer and malnutrition. Clinical trial identification number. NCT02151214 IMPLICATIONS FOR PRACTICE: This clinical trial showed that parenteral nutrition improved neither quality of life nor survival and generated more serious adverse events than oral feeding only among patients with advanced cancer cachexia and no intestinal impairment. Parenteral nutrition should not be prescribed for patients with advanced cancer, cachexia, and no intestinal failure when life expectancy is shorter than 3 months. Further studies are needed to assess the useful period with a potential benefit of artificial nutrition for patients with advanced cancer.

Keywords: Cancer; Malnutrition; Palliative care; Parenteral nutrition; Zelen's method.

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Conflict of interest statement

Disclosures of potential conflicts of interest may be found at the end of this article.

Figures

Figure 1
Figure 1
Flowchart of the study population.Abbreviations: mITT, modified intent to treat; PN, parenteral nutrition; QoL, quality of life questionnaire.
Figure 2
Figure 2
Kaplan‐Meier curves of health‐related quality of life deterioration‐free survival for the three target dimensions and time to performance status deterioration.Abbreviations: CI, confidence interval; HR, hazard ratio; OF, oral feeding; PN, parenteral nutrition.
Figure 3
Figure 3
Overall survival curve according to the Kaplan‐Meier estimate per treatment arm (intention‐to‐treat population).Abbreviations: CI, confidence interval; HR, hazard ratio; OF, oral feeding; PN, parenteral nutrition.
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