Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy
Primary Purpose
Head-neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Intensive nutritional counseling
Nutritional counseling
Sponsored by
About this trial
This is an interventional treatment trial for Head-neck Cancer
Eligibility Criteria
Inclusion Criteria:
- newly diagnosed head-neck cancer
- indication to radiotherapy
- Eastern Cooperative Oncology Group performance status <=2
- availability to planned measurements and to written informed consent.
Exclusion Criteria:
- age <18 years
- ongoing artificial nutrition
- refusal
Sites / Locations
- Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intensive nutritional counseling
Nutritional counseling
Arm Description
Nutritional counseling (follow-up visits once a week for 6 weeks [during radiotherapy] and at 1 month and at 3 months since the end of radiotherapy) + n-3 polyunsaturated fatty acids-enriched oral nutritional supplements (1-2 bottles/day)
Nutritional counseling (follow-up visits once a week for 6 weeks [during radiotherapy] and at 1 month and at 3 months since the end of radiotherapy)
Outcomes
Primary Outcome Measures
Body weight
Change in body weight at the end of radiotherapy (after 6 weeks)
Secondary Outcome Measures
Body weight
Change in body weight at 1 month since the end of radiotherapy
Body weight
Change in body weight at 3 months since the end of radiotherapy
Quality of life
Trends in quality of life during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)
Handgrip strength
Trends in handgrip strength during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)
Phase angle
Trends in phase angle (as surrogate of body composition) during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)
Full Information
NCT ID
NCT02055833
First Posted
February 4, 2014
Last Updated
August 29, 2016
Sponsor
IRCCS Policlinico S. Matteo
Collaborators
Nestlé Health Science Spain, Akern Srl
1. Study Identification
Unique Protocol Identification Number
NCT02055833
Brief Title
Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy
Official Title
Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy: a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo
Collaborators
Nestlé Health Science Spain, Akern Srl
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In head-neck cancer patients undergoing radiotherapy (RT) malnutrition is associated with impaired quality of life, reduced survival, more frequent treatment interruptions and dose reductions. The international guidelines recommend early nutritional support in the presence of nutritional risk, as it allows preventing or treating malnutrition and improving the clinical outcomes, as well as the tolerability of oncologic treatments. Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head-neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive nutritional counseling
Arm Type
Experimental
Arm Description
Nutritional counseling (follow-up visits once a week for 6 weeks [during radiotherapy] and at 1 month and at 3 months since the end of radiotherapy) + n-3 polyunsaturated fatty acids-enriched oral nutritional supplements (1-2 bottles/day)
Arm Title
Nutritional counseling
Arm Type
Active Comparator
Arm Description
Nutritional counseling (follow-up visits once a week for 6 weeks [during radiotherapy] and at 1 month and at 3 months since the end of radiotherapy)
Intervention Type
Dietary Supplement
Intervention Name(s)
Intensive nutritional counseling
Other Intervention Name(s)
Resource Support Plus (Nestlè Health Science)
Intervention Description
Intensive nutritional counseling: nutritional counseling + oral nutritional supplements
Intervention Type
Other
Intervention Name(s)
Nutritional counseling
Intervention Description
Nutritional counseling
Primary Outcome Measure Information:
Title
Body weight
Description
Change in body weight at the end of radiotherapy (after 6 weeks)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Body weight
Description
Change in body weight at 1 month since the end of radiotherapy
Time Frame
3 months
Title
Body weight
Description
Change in body weight at 3 months since the end of radiotherapy
Time Frame
5 months
Title
Quality of life
Description
Trends in quality of life during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)
Time Frame
5 months
Title
Handgrip strength
Description
Trends in handgrip strength during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)
Time Frame
5 months
Title
Phase angle
Description
Trends in phase angle (as surrogate of body composition) during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)
Time Frame
5 months
Other Pre-specified Outcome Measures:
Title
Feasibility of radiotherapy
Description
Described as: number of interruptions >5 days; total duration (days); dose reduction
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
newly diagnosed head-neck cancer
indication to radiotherapy
Eastern Cooperative Oncology Group performance status <=2
availability to planned measurements and to written informed consent.
Exclusion Criteria:
age <18 years
ongoing artificial nutrition
refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuele Cereda, MD, PhD
Organizational Affiliation
Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Riccardo Caccialanza, MD
Organizational Affiliation
Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
Official's Role
Study Director
Facility Information:
Facility Name
Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
23845384
Citation
Langius JA, Zandbergen MC, Eerenstein SE, van Tulder MW, Leemans CR, Kramer MH, Weijs PJ. Effect of nutritional interventions on nutritional status, quality of life and mortality in patients with head and neck cancer receiving (chemo)radiotherapy: a systematic review. Clin Nutr. 2013 Oct;32(5):671-8. doi: 10.1016/j.clnu.2013.06.012. Epub 2013 Jun 26.
Results Reference
background
PubMed Identifier
22345712
Citation
Baldwin C, Spiro A, Ahern R, Emery PW. Oral nutritional interventions in malnourished patients with cancer: a systematic review and meta-analysis. J Natl Cancer Inst. 2012 Mar 7;104(5):371-85. doi: 10.1093/jnci/djr556. Epub 2012 Feb 15.
Results Reference
background
PubMed Identifier
16697500
Citation
Arends J, Bodoky G, Bozzetti F, Fearon K, Muscaritoli M, Selga G, van Bokhorst-de van der Schueren MA, von Meyenfeldt M; DGEM (German Society for Nutritional Medicine); Zurcher G, Fietkau R, Aulbert E, Frick B, Holm M, Kneba M, Mestrom HJ, Zander A; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Non-surgical oncology. Clin Nutr. 2006 Apr;25(2):245-59. doi: 10.1016/j.clnu.2006.01.020. Epub 2006 May 12.
Results Reference
background
PubMed Identifier
34130709
Citation
Martin B, Cereda E, Caccialanza R, Pedrazzoli P, Tarricone R, Ciani O. Cost-effectiveness analysis of oral nutritional supplements with nutritional counselling in head and neck cancer patients undergoing radiotherapy. Cost Eff Resour Alloc. 2021 Jun 15;19(1):35. doi: 10.1186/s12962-021-00291-7.
Results Reference
derived
PubMed Identifier
29111172
Citation
Cereda E, Cappello S, Colombo S, Klersy C, Imarisio I, Turri A, Caraccia M, Borioli V, Monaco T, Benazzo M, Pedrazzoli P, Corbella F, Caccialanza R. Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy. Radiother Oncol. 2018 Jan;126(1):81-88. doi: 10.1016/j.radonc.2017.10.015. Epub 2017 Oct 27.
Results Reference
derived
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Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy
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