The purpose of the research was to investigate in cancer patients referred for radiotherapy:

• Quality of life (QOL), nutrition status and nutrient intake at onset and end of radiotherapy (RT)
• Effect of individualized nutrition counseling on nutrient intake over time, and whether nutrient intake influenced the patient's QOL
• Which symptoms might be indicative of poorer QOL and reduced nutritional intake.

• Oncology outpatient referred to the radiotherapy department of the study hospital between July 2000 and February 2001 for primary, adjuvant to surgery or palliative radiotherapy. Medical staff assessed patients' clinical variables; cancer location; and tumor, nodes, and metastases (TNM) staging prior to decision for radiotherapy planning
• No distant metastases. 

• Terminally ill
• Renal failure (Creatinine higher than 532µmol per L)
• Congestive heart failure
• Hepatic failure (Bilirubin higher than 21µmol per L).

Recruitment

• All cancer patients referred to the outpatient Radiotherapy department of the study hospital between July 2000 and February 2001 were considered eligible
• No specific information on recruiting method was provided.

Design

• The study was designed as a prospective descriptive study
• The study design was approved by the University Hospital Ethics Committee
• Patients were classified as either high risk (HR) or low risk (LR) for nutritional problems
  • Patients with head and neck cancers or GI cancers were classified as HR
  • All other patients were classified as LR.

Intervention

Patients were nutritionally assessed by a research dietitian:

• Individualized dietary counseling was provided based on patients' current intakes
• No oral nutritional supplements or tube feedings were used during this study.

Statistical Analysis

• Study data was analyzed on the intent-to-treat principle
• Sample size was calculated according to Wittes; to increase statistical power, patients were divided into HR and LR categories
• Descriptive data were expressed as number and percentage, mean or median values
• Level of significance for all statistics was P<0.05
• Kruskal-Wallis analysis, the Mann-Whitney U-test, and student's T-test were used to analyze associations and differences between groups in QOL measures, nutrition status and nutrition intake
• Chi-square testing was used to compare frequencies
• Spearman and Kendal Tau methods were used to analyze correlations between nutrition intake or nutrition status and QOL scores
• Regression analysis was used to identify variables that influence nutrition intake and QOL. 

Timing of Measurements

• Assessment of nutritional status, food intake and individual nutrition counseling needs were performed for each patient by a research dietitian at onset of radiotherapy, after two weeks of radiotherapy and at the end of radiotherapy
• Quality of life was evaluated at the onset of radiotherapy and at the end of radiotherapy.

Dependent Variables

• Variable 1:  Nutritional status:
  • Nutrition assessment was performed using Ottery's Subjective Global Assessment (SGA)
    • SGA is validated for cancer patients
    • Assessment addresses:
      • Weight changes
      • Symptoms, including anorexia, nausea, constipation, mucositis, vomiting, diarrhea, xerostomia, pain)
      • Alterations in food intake
      • Functional capacity
      • Metabolic stress, including sepsis, neutropenic fever, use of corticosteroids
      • Anthropometrics, including triceps skinfold, rib skinfold, muscle bulk and tone, ankle or sacral edema, presence of ascites
    • Nutritional status is categorized as one of three degrees: 
      • Normal nutrition status
      • Moderately malnourished
      • Severely malnourished
• Variable 2: QOL:
  • QOL was evaluated using two instruments due to significant differences in length of time required to complete them
  • EUROQOL instrument:
    • Non-disease specific
    • EUROQOL describes and scores health states
      • EUROQOL has two parts:
        • Part One defines health in terms of five areas: Mobility, self-care, usual activities, pain and discomfort, anxiety or depression; combinations of these factors define a total of 243 possible health states
        • Part Two asks the patient to record his or her perceptions of his or her overall health, using a visual analog scale with zero representing the worst possible health and 100 representing the best possible health
  • EORTC-QLQ C30, Version 3.0:
    • Cancer-specific, 30-item questionnaire
      • Includes five functional scales (physical, emotional, cognitive, social and role)
      • Includes three symptom scales (fatigue, pain, nausea or vomiting)
      • Includes six single items assessing symptoms and financial impact of disease
    • Higher scores on the function scales indicate better functioning
    • Higher scores on the symptom scales indicate more severe symptoms.

Independent Variables

• Dietary assessment:

  • Harris-Benedict was not used due to problems with accuracy
  • Height was copied from patient's identity card
  • Weight was measured using a Jofre floor scale

  • Basal energy requirements (BMR) were estimated using the World Health Organization formula for patients 18 to 60 years of age:
    • Men: 
      • 18 to 30 years:  [64.4 x weight (kg) - 113 x height (m) + 3,000]
      • 30 to 60 years:  [19.2 x weight (kg) + 66.9 x height (m) + 3,769]
    • Women:
      • 18 to 30 years:  [55.6 x weight (kg) - 1,397.4 x height (m) + 146]
      • 30 to 60 years:  [36.4 x weight (kg) + 104.6 x height (m) + 3,619]
  • For patients more than 60 years of age, the Owen et al formulas were used
    • Men: [879 + (10.2 x weight (kg)) x 4.184]

  • Women: [795 + (7.18 x weight (kg)) x 4.184]
  • Daily estimated energy requirements were calculated by multiplying BMR by an activity factor of 1.2

• Nutritional intake assessment:
  • Was assessed by 24-hour food recall questionnaire
  • Nutrient content was analyzed by DIETPLAN for Windows software (Forestfield Software Ltd 2001, Horsham, UK).

 Control Variables

• HR or LR cancer
• Dietary counseling
  • Nutrition counseling took into account each patient's:
    • Current eating habits
    • Actual nutritional status
    • Need for increased intake to overcome deficits
    • Known food aversions
    • Reported symptoms
    • Diet adequacy, which determined variations in each patient's daily meal plan, diet nutrient content, type and amount of foods and appropriate diet texture.

Initial N

• N: 125 (83 males, 42 females)
• HR patients: 80
• LR patients: 45

Patient Groups and Cancer Staging

Nutritional Status Prior to Therapy

• High-risk patients:
  • Five of six esophageal cancer patients were moderately or severely malnourished
  • Five of five stomach cancer patients were moderately or severely malnourished
  • 12 of 23 head and neck cancer patients were moderately or severely malnourished
  • Six of 46 colorectal cancer patients were moderately or severely malnourished
• Low-risk patients:
  • 10 of 45 low-risk cancer patients were moderately malnourished
  • No low-risk cancer patient was severely malnourished.

Attrition (Final N)

All data was analyzed on the intent-to-treat principle.

Age

63±11 years (33 to 86 years).

Anthropometrics

At beginning and at end of radiotherapy, high-risk patients were more likely to be malnourished (P<0.02).

Location

Lisbon, Portugal. 

Findings

• Nutrition status:
  • At onset and at end of radiation therapy, malnutrition (moderate and severe) was present more often in the high-risk group than the low-risk group (P=0.02)
  • From beginning to end of radiation therapy, nutrition status remained stable in all but one high-risk head and neck cancer patient whose nutrition status deteriorated from moderately to severely malnourished
• Symptoms: From beginning to end of radiation therapy, only in high-risk patients did symptoms of diarrhea or anorexia increase in severity during radiotherapy (P=0.0001); no patients reported grade three o four symptoms
• Energy intake:
  • At onset of radiotherapy, median energy intake of low-risk patients was higher than median energy intake of high-risk patients (P=0.002)
  • In both high-risk and low-risk patients, baseline nutrition status was related to nutritional intake (P=0.007)
  • Energy intake increased significantly in high-risk patients during radiotherapy (P<0.03), and patients attributed the increase to individualized nutrition counseling:
    • Esophageal cancer: +275kcals (200 to 425)
    • Stomach cancer: + 280kcals (185 to 400)
    • Colorectal: +410 (352 to 545)
    • Head and neck: +510 (358 to 785)
    • Increase in energy intake in low-risk patients was not significant
• Overall quality of life measures:
  • For all quality of life measures, and for overall quality of life, high-risk patients reported worse scores than low-risk patients, both at initial measurement (P=0.001) and at end of radiation therapy (P=0.01). Patients with esophageal, stomach, and head and neck cancers reported the lowest quality of life scores
  • With the exception of pain and discomfort, all quality of life scores improved significantly from beginning to end of treatment; improvement was significant only in high-risk patients (P=0.004)
    • Pain and discomfort during radiation therapy was associated with symptoms of greater severity:
      • Anorexia (P=0.001)
      • Diarrhea (P=0.002)
      • Dysphagia (P=0.01)
      • Odynophagia (P=0.04)
    • Nutritional intake of high-risk patients improved throughout radiation therapy
  • Improvement of nutritional intake was identified as a major factor in the improvement in quality of life seen from beginning to end of radiation therapy for high-risk patients (R=0.78; P=0.001). In low-risk patients, no nutrition parameters were significantly associated with quality of life.
  • Self-reported health status (SRHS) was significantly higher in low-risk than high-risk patients at outset of radiation therapy (P<0.03)
    • At end of radiation therapy, SRHS improved in all groups, but the change was significant only for high-risk patients (P=0.01)
    • In high-risk patients only, energy intake was associated with SRHS at both beginning and end of radiation therapy (R=0.47, P=0.001). Multi-variate analysis indicated that nutritional intake was associated with an increase in SRHS (R=0.72; P=0.001), demonstrating that increased energy intake promoted improved SRHS.
  • Worse function scales were reported for high-risk patients with baseline malnutrition (these associations were also present at end of treatment):
    • Global QOL (P=0.05)
    • Physical (P=0.01)
    • Role (P=0.02)
    • Cognitive (P=0.02)
    • Emotional (P=0.01)
    • Social (P=0.01) 
  • Function scales were correlated with baseline energy intake for high-risk patients: 
    • Global quality of life (R=0.53, P=0.01)
    • Physical (R=0.26, P=0.02)
    • Emotional (R=0.29, P=0.01)
  • At end of radiation therapy, multivariate analysis identified nutritional intake as the only variable associated with global quality of life (P=0.001), physical (P=0.03), role (P=0.01) and emotional (P=0.04) functions for high-risk patients
  • Increase in high-risk patients' nutritional intake was correlated with the increase in global quality of life (R=0.78, P=0.001), physical (R=0.68, P=0.002) and emotional functions (R=0.67, P = 0.002).

The authors concluded that improved nutritional intake in high-risk cancer patients undergoing radiotherapy contributes to better quality of life, and that nutrition counseling during radiation therapy is a feasible and effective intervention to achieve improved nutritional intake. 

• High-quality study highlighting the importance of nutrition intervention by a nutrition professional during radiation therapy
• Determination of high-risk and low-risk cancers made by researchers
• Quality of life measures depend largely on self-reports by patients.