Non-Randomized Controlled Trial

C - Click here for explanation of classification scheme.

NEUTRAL: See Quality Criteria Checklist below.

• 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).

• 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).

None listed.

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.

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.

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≥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.

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.

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.

Other:

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

• 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.