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Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055833
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : August 30, 2016
Sponsor:
Collaborators:
Nestlé Health Science Spain
Akern Srl
Information provided by (Responsible Party):
Emanuele Cereda, IRCCS Policlinico S. Matteo

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.

Condition or disease Intervention/treatment Phase
Head-neck Cancer Dietary Supplement: Intensive nutritional counseling Other: Nutritional counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy: a Randomized, Controlled Trial
Study Start Date : September 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intensive nutritional counseling
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)
Dietary Supplement: Intensive nutritional counseling
Intensive nutritional counseling: nutritional counseling + oral nutritional supplements
Other Name: Resource Support Plus (Nestlè Health Science)

Active Comparator: Nutritional counseling
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)
Other: Nutritional counseling
Nutritional counseling




Primary Outcome Measures :
  1. Body weight [ Time Frame: 6 weeks ]
    Change in body weight at the end of radiotherapy (after 6 weeks)


Secondary Outcome Measures :
  1. Body weight [ Time Frame: 3 months ]
    Change in body weight at 1 month since the end of radiotherapy

  2. Body weight [ Time Frame: 5 months ]
    Change in body weight at 3 months since the end of radiotherapy

  3. Quality of life [ Time Frame: 5 months ]
    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)

  4. Handgrip strength [ Time Frame: 5 months ]
    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)

  5. Phase angle [ Time Frame: 5 months ]
    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)


Other Outcome Measures:
  1. Feasibility of radiotherapy [ Time Frame: 6 weeks ]
    Described as: number of interruptions >5 days; total duration (days); dose reduction



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055833


Locations
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Italy
Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Nestlé Health Science Spain
Akern Srl
Investigators
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Principal Investigator: Emanuele Cereda, MD, PhD Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
Study Director: Riccardo Caccialanza, MD Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emanuele Cereda, MD, PhD, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT02055833    
Other Study ID Numbers: 20120001310
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms