Intensive Nutrition Counselling in Patients With Head and Neck Cancer

NCT ID: NCT02159508

Last Updated: 2014-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2014-12-31

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.

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.

Conditions

Head and Neck Squamous Cell Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Nutritional counselling

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of primary locally advanced squamous cell carcinoma of the oral cavity, pharynx, nasopharynx or larynx

Exclusion Criteria

• renal function impairment
• liver insufficiency
• heart failure
• pulmonal impairment
• Chronic obstructive pulmonary disease
• cognitive impairment
• previous cancer in any location
• terminal stage

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Helsinki

OTHER

Sponsor Role: collaborator

University of Eastern Finland

OTHER

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Helena Orell-Kotikangas

Dietitian

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antti Mäkitie, Professor

Role: STUDY_DIRECTOR

Helsinki University Central Hospital

Locations

Department of Otolaryngology - Head & Neck Surgery, Helsinki University Central Hospital and University of Helsinki

Helsinki, HUS, Finland

Countries

Finland

References

Isenring EA, Bauer JD, Capra S. Nutrition support using the American Dietetic Association medical nutrition therapy protocol for radiation oncology patients improves dietary intake compared with standard practice. J Am Diet Assoc. 2007 Mar;107(3):404-12. doi: 10.1016/j.jada.2006.12.007.

Reference Type: BACKGROUND

PMID: 17324657 (View on PubMed)

Ottery FD. Definition of standardized nutritional assessment and interventional pathways in oncology. Nutrition. 1996 Jan;12(1 Suppl):S15-9. doi: 10.1016/0899-9007(96)90011-8.

Reference Type: BACKGROUND

PMID: 8850213 (View on PubMed)

White JV, Guenter P, Jensen G, Malone A, Schofield M; Academy of Nutrition and Dietetics Malnutrition Work Group; A.S.P.E.N. Malnutrition Task Force; A.S.P.E.N. Board of Directors. Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). J Acad Nutr Diet. 2012 May;112(5):730-8. doi: 10.1016/j.jand.2012.03.012. Epub 2012 Apr 25.

Reference Type: BACKGROUND

PMID: 22709779 (View on PubMed)

Orell H, Schwab U, Saarilahti K, Osterlund P, Ravasco P, Makitie A. Nutritional Counseling for Head and Neck Cancer Patients Undergoing (Chemo) Radiotherapy-A Prospective Randomized Trial. Front Nutr. 2019 Mar 18;6:22. doi: 10.3389/fnut.2019.00022. eCollection 2019.

Reference Type: DERIVED

PMID: 30937304 (View on PubMed)

Other Identifiers

322-E9-05

Identifier Type: -

Identifier Source: org_study_id