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Intensive Nutrition Counselling in Patients With Head and Neck Cancer

Primary Purpose

Head and Neck Squamous Cell Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Nutritional counselling
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Squamous Cell Cancer focused on measuring nutritional status, nutritional intervention, handgrip strength, patient-generated subjective global assessment, chemoradiotherapy, survival

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Individualised on-demand counselling

Intensive nutritional counselling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Nutritional status
Nutritional status was assessed by patient-generated subjective global assessment and anthropometry.

Secondary Outcome Measures

Survival
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.

Full Information

First Posted
April 29, 2014
Last Updated
June 9, 2014
Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki, University of Eastern Finland
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1. Study Identification

Unique Protocol Identification Number
NCT02159508
Brief Title
Intensive Nutrition Counselling in Patients With Head and Neck Cancer
Official Title
An Intervention Study Comparing Intensive Nutrition Counselling With On-demand Counselling in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki, University of Eastern Finland

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Cancer
Keywords
nutritional status, nutritional intervention, handgrip strength, patient-generated subjective global assessment, chemoradiotherapy, survival

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualised on-demand counselling
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intensive nutritional counselling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nutritional status
Description
Nutritional status was assessed by patient-generated subjective global assessment and anthropometry.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Survival
Description
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.
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antti Mäkitie, Professor
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Otolaryngology - Head & Neck Surgery, Helsinki University Central Hospital and University of Helsinki
City
Helsinki
State/Province
HUS
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
17324657
Citation
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.
Results Reference
background
PubMed Identifier
8850213
Citation
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.
Results Reference
background
PubMed Identifier
22709779
Citation
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. Erratum In: J Acad Nutr Diet. 2012 Nov;112(11):1899. J Acad Nutr Diet. 2017 Mar;117(3):480.
Results Reference
background
PubMed Identifier
30937304
Citation
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.
Results Reference
derived

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Intensive Nutrition Counselling in Patients With Head and Neck Cancer

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