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

Citation:

Isenring EA, Capra S, Bauer, J.D. Nutrition intervention is beneficial in oncology outpatients receiving radiotherapy to the gastrointestinal or head and neck area. Brit J Cancer. 91: 447-452; 2004.

PubMed ID: 15226773
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:

To determine the impact of early and intensive nutrition intervention (NI) on body weight, body composition, nutritional status, global quality of life and physical function compared to usual practice (UC) in oncology outpatients receiving radiotherapy to the GI or head and neck area. 

Inclusion Criteria:

Commencing to a minimum of 20 fractions of radiotherapy to the GI or head and neck during a 12-month period.

Exclusion Criteria:
  • Less than 18 years of age
  • Hospital inpatients for more than five days
  • Receiving enteral or parenteral nutrition
  • Unable to provide informed consent.
Description of Study Protocol:

Recruitment

All outpatients eligible at a private Australian radiation-oncology facility. 

Design

Prospective randomized-controlled trial. 

Intervention 

  • Regular and intensive counseling by an RD for 12 weeks. Counseling was provided within the first four days of starting radiation and then weekly for the course of radiation (approximately six weeks) and then every two weeks for the remaining time. Subjects were given individually tailored sample meal plans, recipe suggestions and hints to minimize the side effects of the tumor and therapy. If determined necessary, the RD provided a weekly supply of oral nutrition supplements for up to three months.
  • The usual care (UC) group was educated by the nurses, given the booklet Understanding Nutrition and given oral nutrition supplement samples. If they received radiation to the head and neck, they were referred to the RD. If the patient received radiation in other body areas, they could request a RD referral. The  UC had a maximum of two RD consults.

Statistical Analysis

All analysis were on an intention to treat basis. Repeated measure analysis were carried out for weight, nutritional status and global quality of life (QOL). Weight gain or a weight loss of less than 1kg over two to three months was deemed as weight stable. The proportion of patients who were weight stable was calculated using T-tests.

Data Collection Summary:

Timing of Measurements

 At the start of radiotherapy, and at four, eight and 12 weeks following baseline. 

Dependent Variables

  • Body weight
  • Fat free mass (FFM) by foot-foot bioelectrical impedance 
  • Nutritional status by scored Patient-Generated Subjective Global Assessment (PG-SGA)
  • Global QOL by European Organization for the Research and Treatment of Cancer QLQ-C30 version three.

Independent Variables

Nutrition intervention vs. usual care. 

Description of Actual Data Sample:
  • Initial N: 60 subjects (24 males and five females in NI; 27 males and four females in UC)
  • Attrition (final N): 54
  • Age:
    • NI: 60.6±15.6 years
    • UC: 63.3±12.5 years
  • Anthropometrics: There were no significant differences between the types of tumor and fraction and dose of radiotherapy of subjects in either group
  • Location: Queensland, Australia.
Summary of Results:

Key Findings

Variables

Treatment Group

Measures and Confidence Intervals

Control Group

Measures and Confidence Intervals

 Statistical Significance of Group Difference
Weight change (kg) -0.4 -4.7 P=0.001
FFM change (kg) +0.5 -1.4 P=0.195

Other Findings

  • The NI group had a significantly smaller deterioration in nutritional status per the PG-SGA score (P=0.02) and they had significantly smaller decrease and faster recovery in global QOL (P=0.009) and in physical function (P=0.012) over time compared to the UC group 
  • Significantly (P=0.016) more NI patients (24%) were weight stable compared with the UC group (11%).

 

Author Conclusion:

Early and intensive NI provides beneficial outcomes of minimizing weight loss, deterioration in nutritional status, global QOL and physical function in ambulatory oncology patients receiving radiotherapy to the GI or head and neck areas. Weight maintenance vs. weight gain, may be a more appropriate aim of nutrition support during radiotherapy.

Funding Source:
University/Hospital: School of Public Health, Queensland University of Technology, Brisbane, Australia
Reviewer Comments:

There was no measurement of compliance with the RD recommendations.

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) No
  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.) Yes
  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? N/A
  4.1. Were follow-up methods described and the same for all groups? N/A
  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%.) N/A
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? N/A
  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? N/A
  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? No
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? Yes
  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? ???
  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? 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? 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)? Yes
  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