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ONC: Nutrition Status and Outcomes in Adult Oncology Patients (2013)

Citation:

Capuano G, Grosso A, Gentile PC, Battista M, Bianciardi F, Di Palma A, Pavese I, Satta F, Tosti M, Palladino A, Coiro G, Di Palma M. Influence of weight loss on outcomes in patients with head and neck cancer undergoing concomitant chemoradiotherapy. Head Neck. 2008 Apr; 30(4): 503-508.

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

To determine the influence of weight loss on outcomes in patients with head and neck cancer undergoing concomitant chemoradiotherapy (CCRT):

  • Treatment interruption
  • Infections
  • Mortality
  • Hospital readmission rate.
Inclusion Criteria:
  • Head and neck cancer; stage III or IV that is unresectable and non-metastasized
  • Referred to CCRT
  • Karnofsky performance score 60 or higher.

 

Exclusion Criteria:
  • Comorbidity (diabetes, hepatic failure, renal failure)
  • Prior surgery
  • Prior RT or CCRT treatment for head and neck or other cancer
Description of Study Protocol:

Recruitment

All patients at the center in Rome from January 2003 to December 2006 meeting eligibility criterion were enrolled in the study.

Design

As weight loss during cancer treatment is correlated with increased risk of mortality, nutrition counseling and intervention (enteral and parenteral nutrition) were used as treatment for patients with head and neck cancer. Differences in patients who were compliant vs. those not compliant with nutrition program recommendations were assessed in this small study.

Intervention

Three part nutritional program for all study participants:

  • Intensive dietary counseling (weeks one to two): Regular foods with texture modifications as needed to meet individual patients' needs
  • Enteral nutrition via nasogastric (NG) tube (week three until adequate intake resumes). If patients were not compliant with NG feedings, parenteral nutrition was prescribed.
  • Intensive dietary counseling: From removal of NG tube until resumption of normal food intake.

Statistical Analysis

  • Analysis was completed using Primer of BioStatistics version 5.0:
    • Body weight: Analyzed using paired Student's T-test
    • Mortality, treatment interruption, hospital readmission rate: Fisher exact test
    • Infection risk: Risk ratio test
    • Correlations: Non-parametric Spearman test
    • Survival: Log-rank test.
  • Significance P<0.05.
Data Collection Summary:

Timing of Measurements

January 2003 to December 2006.

Dependent Variables

  • Treatment interruptions
  • Infections
  • Early mortality
  • Hospital readmission rate.

Independent Variables

  • Patient body weight (kg)
  • Serum prealbumin.

Control Variables

  • Presence of head and neck cancer
  • Provision of nutritional counseling
  • Nutrition support.
Description of Actual Data Sample:
  • Initial N:  40 (22 males, 18 females)
  • Attrition: 40
    Age: Median age 58 years (18 to 78 years).

Other Relevant Demographics

  • Three patients were affected by alcohol dependence
  • Median Karnofsky performance score 80 (range 60 to 100).

Anthropometrics

  • Median BMI: 24 (range 16.5 to 32.7)
  • Median serum prealbumin: 25±5.

Location

Rome, Italy.

 

Summary of Results:

Key Findings

23 patients had weight loss less than 20%.

  All Participants Weight Loss More Than 20% Weight Loss Less Than 20% Statistical Significance of Group Difference
Treatment Interruptions       The interruption of oncological treatment was correlated with weight loss percentage (Spearman's test: R=0.484, P=0.003). 
 
 
Stopped more than five days 10  53%  4% 
Stopped definitely   29%  4% 
Infections Nine patients 23%  47%  4%  Infection risk was significantly higher in patients with body weight loss higher than 20% (RR=0.092; 95% CI: .013 to 0.671; chi-square=7.923; P=0.005). 
Early mortality Seven patients      Long-rank test: Z=-2.722, P=0.006. 
Hospital readmission rate 32% of surviving patients  53%  13% 

Spearman test: R=0.590; P=0.001.

 

 

Other Findings

  • 53% of patients complied with the nutritional program; 47% did not accept nutrition counseling.  Compliance was considered to be acceptance of a PEG tube during CCRT; non-compliance was considered to be refusal to accept a PEG tube and continuance of oral intake only during CCRT.
  • No compliant patient needed parenteral nutrition
  • 89% of non-compliant patients stopped taking food and fluids orally after three to four weeks of CCRT
  • 84% of non-compliant patients were admitted to the hospital because of severe malnutrition or dehydration
  • All non-compliant patients admitted to the hospital required parenteral nutrition due to refusal of PEG placement and because severe oropharyngeal mucositis prevented NG insertion
  • At end of treatment, 76% of compliant patients increased or maintained serum prealbumin, while no non-compliant patient maintained serum prealbumin (27±6mg per dL vs. 16±5mg per dL, P<0.001).
Author Conclusion:

In patients with head and neck cancer undergoing CCRT, the early nutritional management reduced weight loss and improved outcomes. Nutrition intervention should be provided to these patients before, during and after treatment.

Funding Source:
University/Hospital: Ospedale San Pietro
Reviewer Comments:
  • Small study (40 total people)
  • It is unclear whether differences between compliant and non-compliant patients were analyzed as part of a post-hoc analysis.
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? N/A
  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? N/A
3. Were study groups comparable? ???
  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? No
  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? N/A
  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? Yes
  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.) N/A
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  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? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  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? Yes
  6.6. Were extra or unplanned treatments described? Yes
  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? Yes
  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? Yes
  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? ???
  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? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  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? No
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? ???
  10.2. Was the study free from apparent conflict of interest? Yes