NCT02159508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 10, 2014

Status Verified

May 1, 2014

Enrollment Period

7.1 years

First QC Date

April 29, 2014

Last Update Submit

June 9, 2014

Conditions

Head and Neck Squamous Cell Cancer

Keywords

nutritional statusnutritional interventionhandgrip strengthpatient-generated subjective global assessmentchemoradiotherapysurvival

Outcome Measures

Primary Outcomes (1)

  • Nutritional status

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

    6 months

Secondary Outcomes (1)

  • Survival

    5 year

Study Arms (2)

Individualised on-demand counselling

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

Nutritional counsellingBEHAVIORAL

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.

Intensive nutritional counselling

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Helsinki, HUS, 00029, Finland

Location

Related Publications (4)

  • 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.

    PMID: 17324657BACKGROUND

  • 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.

    PMID: 8850213BACKGROUND

  • 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.

    PMID: 22709779BACKGROUND

  • 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.

    PMID: 30937304DERIVED

Study Officials

  • Antti Mäkitie, Professor

    Helsinki University Central Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dietitian

Study Record Dates

First Submitted

April 29, 2014

First Posted

June 10, 2014

Study Start

November 1, 2007

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 10, 2014

Record last verified: 2014-05

Locations

FI(1)