title: Individualized nutrition intervention is of major benefit to colorectal cancer patients: long-term follow-up of a randomized controlled trial of nutritional therapy.
abstract: BACKGROUND
  In our published randomized trial in colorectal cancer, group 1 (n = 37) received individualized nutritional counseling and education about regular foods, group 2 (n = 37) received dietary supplements and consumed their usual diet of regular foods, and group 3 (n = 37) consumed their usual diet of regular foods. Neither group 2 nor group 3 received individualized counseling. Early nutritional counseling during radiotherapy was highly effective at reducing acute radiotherapy toxicity and improving nutritional intake/status and quality of life (QoL). Efficacy persisted for 3 mo after the intervention.
  
  
  OBJECTIVE
  The objective was to perform long-term follow-up in survivors of that clinical trial to specifically evaluate survival, late toxicity, QoL, and nutritional variables.
  
  
  METHODS
  Medical data were collected from patients' records, and prescheduled interviews were conducted by dietitians for individualized evaluations. Analyses and comparisons between groups (adjusted for stage) were performed after a median follow-up of 6.5 (range: 4.9-8.1) y.
  
  
  RESULTS
  Patients complied with the Radiotherapy Department's follow-up protocol. Nutritional deterioration was higher (P < 0.001) in group 3 (n = 26) and group 2 (n = 29) than in group 1 (n = 34). Adequate nutritional status was maintained in 91% of group 1 patients but not in any of the group 3 patients (P < 0.002). Intakes in group 1 were similar to reference values, and the patients adhered to the prescribed recommendations. Intakes in groups 2 and 3 were lower than recommended intakes: group 3 ≃ group 2 < group 1 (P = 0.001). Median survival in group 3 was 4.9 y (30% died), in group 2 was 6.5 y (22% died), and in group 1 was 7.3 y (only 8% died): group 3 > group 2 > group 1 (P < 0.01). Late radiotherapy toxicity was higher in group 3 (n = 17; 65%) and group 2 (n = 17; 59%) than in group 1 (n = 3; 9%): group 3 ≃ group 2 > group 1 (P < 0.001). QoL was worse in groups 3 and 2 than in group 1: group 3 ≃ group 2 < group 1 (P < 0.002). Worse radiotherapy toxicity, QoL, and mortality were associated with deteriorated nutritional status and intake (P < 0.001). Likewise, depleted intake, nutritional status, and QoL predicted shorter survival and late toxicity (HR: 8.25; 95% CI: 2.74, 1.47; P < 0.001).
  
  
  CONCLUSIONS
  This study conveys novel information about the effectiveness of nutrition at improving long-term prognosis in colorectal cancer. Overall, the data indicate that early individualized nutritional counseling and education during radiotherapy is valuable for patients.
authors.affiliation: Unidade de Nutrição e Metabolismo, Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal. p.ravasco@fm.ul.pt
authors.forename: Paula
authors.initials: P
authors.lastname: Ravasco
authors.forename: Isabel
authors.initials: I
authors.lastname: Monteiro-Grillo
authors.forename: Maria
authors.initials: M
authors.lastname: Camilo
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000178:diet therapy* / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery; D003131:Combined Modality Therapy / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects / Q000379:methods; D052756:Nutritional Sciences / Q000193:education; D009752:Nutritional Status; D010349:Patient Compliance; D010353:Patient Education as Topic; D057285:Precision Medicine / Q000379:methods*; D011788:Quality of Life; D011832:Radiation Injuries / Q000503:physiopathology / Q000517:prevention & control*; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016019:Survival Analysis