• Increase Font Size
  • Decrease Font Size
  • View as PDF

ONC: Medical Nutrition Therapy and Nutrition Intervention in Adult Oncology Patients (2011)

Citation:

Dintinjana RD, Guina T, Krznaric Z, Radic M, Dintinjana, M. Effects of nutritional support in patients with colorectal cancer durng chemotherapy. Collegium Antropologicum 2008; 3: 737-740.

PubMed ID: 18982745
 
Study Design:
Non-Randomized Controlled Trial
Class:
C - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

To assess the influence of nutritional support including counseling, oral liquids and megestrol acetate on nutritional status and symptoms prevalence in patients with colorectal cancer during chemotherapy.

Inclusion Criteria:
  • Diagnosis of colorectal cancer and undergoing chemotherapy treatment
  • Receiving treatment at Clinical Hospital Centre Rijeka between January 2011 and December 2007
  • Completion of initial evaluation of patient's nutritional status.
Exclusion Criteria:
  • No diagnosis of colorectal cancer or no chemotherapy treatment 
  • Treatment before January 2001 or after December 2007.
Description of Study Protocol:

Recruitment

Recruited from gastroenterology department 

Design

Patients were divided into two groups; group I who were monitored prospectively and were given nutritional support and group II who did not receive proper nutritional counseling and data was collected retrospectively during a six-year period of time. Nutritional support included nutritional counseling, prescription of megestrol acetate and supplementary/adjuvant enteral nutrition. Nutritional status was measured prior to chemotherapy initiation, throughout treatment, and at the conclusion. Nutritional status was evaluated according to body weight change and through three questionnaires: Nottingham Screening Tool Score, Appetite Loss scale and Karnofsky Performance Status. Patients who were considered to have nutritional risk, were those with BMI<20, decrease in weight gain more than 2kg per month and NST score at least five.

Intervention

Nutritional support including counseling, oral liquids and megestrol acetate;

  • All group I subjects received counseling
  • 153 subjects (72%) were taking enteral food supplement
  • 103 patients were using megestrol acetate (48%)

Statistical Analysis

Percentages used to compare data, details of measure of significance not discussed.

 

Data Collection Summary:

Timing of Measurements

  • Group I received nutrition support and was monitored prospectively with body weight measurements and questionnaires completed one week before chemotherapy and for 12 visits accordingly to chemotherapy schedule
  • Group II did not receive nutrition support and was monitored retrospectively with body weight measurements and questionnaires completed one week before chemotherapy and for 12 visits accordingly to chemotherapy schedule.

Dependent Variables

  • BMI
  • Decrease in weight gain
  • Loss of appetite measured by Appetite Loss scale
  • Nottingham Screening Tool score
  • Karnofsky Performance Status.

Independent Variables

Nutrition support including nutritional counseling, prescription of megestrol acetate 400mg daily and supplementary/adjuvant enteral nutrition.

Control Variables

Severity of cancer

 

Description of Actual Data Sample:
  • Initial N: 388 patients
  • Attrition (final N): 388 patients
  • Age:
    • Group I: 68.2±2.6 years
    • Group II: 67±2.9 years
  • Ethnicity: Not described
  • Other relevant demographics: None
  • Anthropometrics:
    • BMI
      • Group I subjects with BMI<20 before chemotherapy: 105 subjects (48.84%)
      • Group II subjects with BMI<20 before chemotherapy: 71 subjects (41.04%)
      • No significant difference in BMI between the groups at baseline
    • Decreasing weight gain (greater than 2kg per month)
      • Group I subjects with decreasing weight gain before chemotherapy: 97 subjects (45.12%)
      • Group II subjects with decreasing weight gain before chemotherapy: 72 subjects (41.62%)
      • No significant difference in decreasing weight gain between groups at baseline 
  • Location: Rijecka, Croatia.

 

Summary of Results:

Key Findings

  • No significant differences between the two groups on initial risk measurements according to BMI, decrease in weight gain and NST (42% vs. 48%, 42% vs. 45% and 45% vs. 52%, respectively
  • BMI
    • Group I who received nutrition support had a 15.3% drop in those who's BMI was <20
    • Group II who did not receive nutrition support had a 12.1% raise in patients with BMI <20
  • Weight loss greater than 2kg per month
    • 65% of patients in group I increased their body weight with an average gain of 1.5kg (0.6-2.8kg) with the greatest weight gain experienced in patients receiving megestrol acetate
    • Group II experienced an increase in weight loss ≥2kg per month in 39% of patients
  • Appetite
    •  Appetite improvement was detected on Appetite Loss Scale from 3.1 at baseline to 4.7 after chemotherapy in group I, especially in patients receiving megestrol acetate
  • KPS Score
    • No significant difference in KPS score was observed, 74.2% before chemotherapy to 80.4% after chemotherapy completion for group I
    • Group II KPS score did not change significantly after chemotherapy, 70.4% before chemotherapy and 70.2% after chemotherapy.
 

Group I

Before Chemotherapy

Group I

After Chemotherapy

Group II

Before Chemotherapy

Group II

Before Chemotherapy

BMI <20

105 (48.84%)

72 (33.49%)

71 (41.04%)

 92 (53.18%)

NTS ≥5

112 (52.10%)

75 (34.88%)

78 (45.09%)

 101 (58.38%)

Loss of appetite

168 (78.14%)

81 (37.67%)

115 (66.47%)

 156 (90.17%)
Decreasing weight gain (greater than 2kg per month) 97 (45.12%) 56 (26.05%) 72 (42.62%) 140 (80.92%)

Other Findings

  • Side effects of enteral food supplementation included diarrhea in 12% of patients, abdominal pain in 9% of patients and bad taste occurring in 5% of patients
  • Water retention with edema was the main side effect experienced in 20% of patients receiving megestrol acetate.

 

Author Conclusion:

The study concludes that nutritional counseling, supplemental feeding and pharmacological support do temporarily stop weight loss and improve appetite, social life and quality of life. This improvement had no implications on patients KPS and course of their disease.

Funding Source:
University/Hospital: University Hospital Center, Rijeka
Reviewer Comments:

Details of measures of statistical testing and levels of significance not discussed.

Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) No
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? Yes
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? No
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? N/A
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) No
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? No
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? No
  6.6. Were extra or unplanned treatments described? No
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? No
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? No
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? No
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? No
  8.1. Were statistical analyses adequately described and the results reported appropriately? No
  8.2. Were correct statistical tests used and assumptions of test not violated? No
  8.3. Were statistics reported with levels of significance and/or confidence intervals? No
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? No
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes