Intensive Nutrition Counselling in Patients With Head and Neck Cancer

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02159508

Collaborator

University of Helsinki (Other), University of Eastern Finland (Other)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effect of a pre-planned patient-adjusted intensive nutritional counselling given by a dietitian several times during (chemo)radiotherapy vs. individualized nutritional counselling given by a dietitian once in the beginning of (chemo)radiotherapy and thereafter on-demand in patients with head and neck squamous cell cancer.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Squamous Cell Cancer	Behavioral: Nutritional counselling	N/A

Detailed Description

A sample size of 102 patients was identified to achieve 30% reduction in prevalence of malnutrition at the end of treatment (50% to 20%), with a significance value of 5% (p < 0.05), 90% power. The second calculation was for a sample size of 88 patients for 30% reduction in prevalence of malnutrition at the end of treatment (50% to 20%) with the significance value 5% (p<0.05), 85% power and effect size 70%. Based on these numbers, our aim is to recruit 100 patients, with the assumption that 12% patients would be lost to follow up.
Randomization will be performed by the minimization procedure with the Minim Program® (http://www-users.york.ac.uk/~mb55/guide/randsery.htm). The allocation will be done according to the following criteria: 1) Stage I-II vs. Stage III-IV; 2) age <65 vs. >=65 year; 3) Body Mass Index <20 vs. >=20 kg/m2 and 4) tumour location (oral cavity-oropharynx-tonsils vs. hypopharynx-larynx vs. nasopharynx).
Adverse events of chemoradiotherapy will be classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events-3.0 (CTCAE v3.0)
Nutritional status will be assessed by patient-generated subjective global assessment, nutritional risk screening-2002, upper-arm anthropometry (MAC, triceps skinfold thickness, MAMA), Bio-impedance, hand grip strength and weight loss.
Survival: overall survival, disease-specific survival and disease-free survival are calculated.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

An Intervention Study Comparing Intensive Nutrition Counselling With On-demand Counselling in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy

Study Start Date :

Nov 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Individualised on-demand counselling Individualized on-demand counselling group was assigned to receive baseline nutritional counselling, that consisted of one dietetic consultation before (chemo)radiotherapy. During (chemo)radiotherapy on-demand counselling group patients received further counselling only on demand.
Experimental: Intensive nutritional counselling Intensive nutritional counselling consisted of protocolled counselling given by a dietitian once at baseline and on the 2nd and 4th week of treatment and at the end of chemoradiotherapy.	Behavioral: Nutritional counselling In both study arms, daily estimated energy requirements were calculated from the basal energy requirements according to WHO multiplied by a 1.5 activity factor and protein requirement (g/day) was calculated multiplying ideal body weight (defined as BMI 22) by 1.2 to 1.5.

Arm

Intervention/Treatment

No Intervention: Individualised on-demand counselling

Individualized on-demand counselling group was assigned to receive baseline nutritional counselling, that consisted of one dietetic consultation before (chemo)radiotherapy. During (chemo)radiotherapy on-demand counselling group patients received further counselling only on demand.

Experimental: Intensive nutritional counselling

Intensive nutritional counselling consisted of protocolled counselling given by a dietitian once at baseline and on the 2nd and 4th week of treatment and at the end of chemoradiotherapy.

Behavioral: Nutritional counselling

In both study arms, daily estimated energy requirements were calculated from the basal energy requirements according to WHO multiplied by a 1.5 activity factor and protein requirement (g/day) was calculated multiplying ideal body weight (defined as BMI 22) by 1.2 to 1.5.

Outcome Measures

Primary Outcome Measures

Nutritional status [6 months]
Nutritional status was assessed by patient-generated subjective global assessment and anthropometry.

Secondary Outcome Measures

Survival [5 year]
Overall survival (OS) is defined as the time interval between the date of the randomization (i.e. at diagnosis) and the date of the last visit or death by any cause.