EAL

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

Citation:

van den Berg MGA, Rasmussen-Conrad EL, Wei KH, Lintz-Luidens H, Kaanders JHAM, Merkx MAW. Comparison of the effect of individual dietary counselling and of standard nutritional care on weight loss in patients with head and neck cancer undergoing radiotherapy. Br J Nutr. 2010; 104: 872-877.

PubMed ID: 20441684

Study Design:

Non-Randomized Controlled Trial

Class:

C - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To evaluate the effect of individual dietary counseling (IDC) by a dietitian for patients with oral cavity, oropharyngeal or hypopharyngeal cancer, undergoing radiotherapy before, during and after the treatment
The objective was to investigate whether individualized dietary counseling by a dietitian would better maintain a patient's body weight and thus prevent malnutrition, compared to standard nutritional care (SC).

Inclusion Criteria:

Patients with primary squamous cell carcinoma in the oral cavity, oropharynx or hypopharynx
Age greater than 18 years
Stages II to IV (International Union Against Cancer TNM classification of malignant tumors).

Exclusion Criteria:

None listed.

Description of Study Protocol:

Recruitment

Patients with head and neck carcinomas were recruited from the Radboud University Nijmergen Medical Centre.

Design

Non-randomized controlled trial
Patients were assigned to one of the intervention groups, based on their postal code.

Blinding Used

Implied (but not stated) for the anthropometric measurements.

Intervention

Standard nutritional care by a nurse (SC)

Patients were seen twice by a dietitian before radiotherapy (IDC policy) and when radiotherapy started they were passed on to SC by a nurse
Nutritional advice was based on a guideline specifically focused on treatment symptoms and how to deal with nutrition
The frequency of advice was at least once a week, but increased when more problems occurred
Patients were seen at the outpatient clinic or contacted by phone up to three to four months after the treatment
Trained nurses, supervised by a radiation oncologist, offered support during and after treatment.

Individual Dietary Counseling (IDC)

Individualized and intensive dietary counseling by dietitians focused on maintaining or improving a patient's energy and protein intake
Based on four nutritional guidelines, which describe treatment-related symptoms that influence dietary intake and offer advice on how to deal with these symptoms, including dietary counseling strategies, when dietary counseling is necessary and when to start tube feeding (nasogastric or gastrostomy)
Each patient had specific nutritional goals and individualized directions for dietary counseling were given
A therapeutic diet was prescribed with regular food, which was adjusted to the individual's usual diet. This included the type, amount and frequency of feeding and specified the energetic or protein level that had to be attained
Oral nutrition supplements were begun if a patient's oral intake continued to decrease. If enteral methods were insufficient, nutritional intake was achieved through tube feeding
From the start of radiotherapy until at least two months after the treatment, patients were checked twice before and at least once per week during and after the radiotherapy
Dietetic consultation consisted of 12 to 15 visits and more frequently if requested.

Statistical Analysis

The percentage of unintended weight-loss was calculated using baseline weight as a reference point
A descriptive statistical analysis was performed for the two groups
Differences in the distribution of patients' characteristics were evaluated by a chi-square test
Independent and dependent Student's T-tests were used to determine differences in the mean change in outcome between and within groups
The difference in malnutrition between the treatment groups was determined by Fisher's exact probability test
Level of statistical significance is P<0.05 using a two-sided test.

Data Collection Summary:

Timing of Measurements

Between January 2005 and February 2007

Baseline
Beginning of treatment (four weeks into study)
End of six weeks of treatment
End of early rehabilitation (two weeks of cessation of treatment)
After eight weeks of rehabilitation.

Dependent Variables

Body weight (kg): Calibrated one decimal Seca scale, wearing lightweight clothing under the same conditions
BMI (kg/m²) and weight category
Malnutrition: Unintended weight loss of at least 5% in one month or at least 10% in six months.

Independent Variables

SC: Standard care
IDC: Individualized dietary counseling.

Control Variables

None listed.

Description of Actual Data Sample:

Initial N

38 patients met inclusion criteria.

Attrition (Final N)

IDC: 20 (14% male)
SC: 18 (8% male).

Age

Average, 62 years

Ethnicity

Not given.

Other Relevant Demographics
Authors stated no significant differences in baseline measures.

		SC	IDC
T Stage	T2	11	6
	T3	4	7
	T4	3	7
N Stage	N0	5	9
N Stage	N≥1	13	11
Tumor Site	Oral cavity	3	10
	Oropharynx	12	7
	Hypopharynx	3	3
Treatment	Radiotherapy	7	6
	Chemo/radiotherapy	5	6
	Surgery/radiotherapy	6	8
Anthropometrics	BMI	24.0±0.9	23.9±1.1
	BMI<18.5	1	3
	BMI 18.5-25.0	12	10
	BMI>25.0	5	7

Location

Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands.

Summary of Results:

Key Findings

Weight loss

Two weeks after treatment: Both groups had 3% unintended weight loss
Two months after treatment: IDC had a 1% weight gain; SC lost 1.5% and was significantly different (P=0.03) between the groups.

BMI

BMI did not differ significantly between the groups at any time-point of the study
No patient was underweight (less than 18.5kg/m²) and most were under 25kg/m².

Malnutrition (from Table Two and text)

Before treatment (diagnosis): Three in SC and four in IDC were malnourished
During the treatment period, patients in both groups remained stable
Two weeks after treatment (early rehabilitation): Five of 18 in SC and none of the 20 in IDC were considered malnourished (P=0.02)
Two months after treatment (rehabilitation): Three of 18 in SC remained malnourished
No significant differences in malnutrition was observed with the T stages.

Other Findings

Treatment-induced side effects peaked at the end of the treatment course and continued for two or more weeks after the treatments.

Author Conclusion:

Early and intensive individualized dietary counseling by a dietitian produced clinically-relevant effects in terms of decreasing weight loss and malnutrition, compared with standard nutritional care in patients with head and neck cancer undergoing radiotherapy.

Funding Source:

Other:

Authors stated no grant was received from any type of agency.

Reviewer Comments:

It was not clear if this was a true randomized trial or not. The patients were assigned to one of the intervention groups based on their postal code. It is unclear what this means, i.e., was one postal code IDC and another SC? Thus the reason for marking it a non-randomized study.
No exclusion criteria was listed and it probably should have been
Authors stated no statistical differences in baseline measures, but this reviewer questions the lack of randomization especially as related to tumor stage and tumor site. Yes, not statistically significant, but given the small N did it still influence the results obtained?
The authors indicated that they were studying dietary counseling in patients receiving radiotherapy, however 11 of the patients also received chemotherapy and 14 surgery plus radiotherapy. There is no discussion on the impact these other treatments could have had on the results obtained. There is also no mention of when chemotherapy or surgery was conducted in relation to radiotherapy. There is no statistical adjustment made for these other treatments. Thus, lack of accounting for additional treatment effects is a flaw with this study.
Another serious flaw in this study is the lack of dietary information and food intake. Records had to have been kept, so why was the information not included? There is also discussion about when tube feeding would be instituted, but there is no data on how many people went on tube feedings and when.

Limitations and Things for Future Research, as Cited by the Authors

Longer follow-up to determine the nadir of weight loss and the duration of full recovery
More data about nutritional status should be included such as a comprehensive nutritional assessment tool, anthropometric measurements and food intake.

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?		???
	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?	No
	2.2.	Were criteria applied equally to all study groups?	???
	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?	???
3.	Were study groups comparable?		No
	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?	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%.)	N/A
	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?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	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.)	Yes
	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?		No
	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?	N/A
	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?	???
	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?	No
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	???
	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)?	N/A
	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