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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 March 2023 |
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Main ID: |
NCT02869399 |
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Date of registration:
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11/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tertiary Prevention of Head and Neck Cancer With a Dietary Intervention
DietINT |
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Scientific title:
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A Randomized Phase II Study for Tertiary Prevention of Squamocellular Cancer of Head and Neck (SCCHN) With a Dietary Intervention |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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94 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02869399 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Austria
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Germany
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Italy
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Poland
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Portugal
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Slovenia
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Contacts
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Name:
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Lisa Licitra, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fondazione IRCCS Istituto Tumori Milano |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- High-risk effectively cured stage III and IV HNSCC
- Oropharyngeal cancer will be enrolled only if with a smoking history of more than 10
pack/years
- Able to swallow at least a soft pureed diet
- Male or female > 18 years
- Signed written informed consent
Exclusion Criteria:
- Serious or uncontrolled co-existent non-malignant disease, including active and
uncontrolled infection
- Non parotid-sparing RT
- Severely malnourished patients (patients with a weight loss greater that 5% in the
last month before enrollment and with a BMI < 20)
- Diabetic patients in pharmacological treatment
- Participation in clinical trials with other experimental agents within 30 days of
study entry or concomitant treatment with other experimental drug
- Previous or concurrent cancer that is distinct in primary site or histology from the
cancer being evaluated in this study
- Other significant disease that in the investigator's opinion would exclude the subject
from the trial
- Patients unable to comply with the protocol, in the opinion of the investigator
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cancer of Head and Neck
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Intervention(s)
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Dietary Supplement: dietary intervention in addition to standard recommendations
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Primary Outcome(s)
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Change in inflammatory cytokine profile during the course of dietary intervention
[Time Frame: 36 months]
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Identification of saliva and plasma miRNAs and evaluation of their change in the 2 arms of treatment
[Time Frame: 36 months]
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Reduction in the incidence of tumor recurrence and second primaries
[Time Frame: 36 months]
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Secondary Outcome(s)
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Identification of cytokine and growth factors
[Time Frame: 36 months]
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Reduction of treatment related side effects
[Time Frame: 36 months]
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Monitoring of DNA methylation
[Time Frame: 36 months]
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EORTC HN35 quality of life scales
[Time Frame: 36 months]
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Secondary ID(s)
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INT 18/15
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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