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Trial record 35 of 54 for:    barley

Tertiary Prevention of Head and Neck Cancer With a Dietary Intervention (DietINT)

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ClinicalTrials.gov Identifier: NCT02869399
Recruitment Status : Unknown
Verified August 2016 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Recruiting
First Posted : August 17, 2016
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:
This is an open-label randomized phase II multicenter trial. An estimated 350 patients deemed to be in complete remission at month 3 after curative treatment are considered for this trial. Two arms of intervention are foreseen: the experimental arm (arm A) based on dietary intervention in addition to standard recommendations and a control arm (arm B) including only standard recommendations. The intervention strategy is based on the AICR/WCRF recommendations for cancer and recurrences prevention and it is focused on decreasing inflammation, glycaemia and insulinaemia while promoting nutrient-rich diet. The reduction in the incidence of tumor recurrence will be analyzed comparing EFS curves between the two arms with the non-parametric Kaplan-Meier method. Secondary analyses will describe the time trend in the prevalence of side effects and quality of life, as assessed by the EORTC QLQ-H&N35 questionnaire. Translational analysis (cytokine, salivary and plasmatic miRNA) will be performed. The trial is coordinated by Istituto Nazionale Tumori, Milan and conducted in 6 European countries.

Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Dietary Supplement: dietary intervention in addition to standard recommendations Phase 2

Detailed Description:

Patients deemed to be in complete remission at month 3 (+/- 1 month) after curative treatment will be considered for this trial.

At each follow up visit the patients will state all the changes and new symptoms they experienced and they will receive both physical and fiberoptic endoscopic head and neck examination. Locoregional imaging should preferentially be performed within 6 months after treatment end and then will be recommended only on the occurrence of new signs or symptoms. Late adverse events of the treatment will be evaluated at each visit according to Common Toxicity Criteria of Adverse Events (CTCAE version 4.0). Quality of life questionnaire (EORTC QLQ HN35) and VSAQ questionnaire will be administered to patients every other visit. Laboratory tests including a complete blood count, renal, hepatic and thyroid function will be performed once a year. The analysis of blood biomarkers of compliance and efficacy will be conducted at baseline, 3, 6, 12, 18 and 24 months after randomization.

The proposed study foresees two arms of intervention: the experimental arm based on dietary intervention in addition to standard recommendations and a control arm which includes only standard recommendations.

The intervention strategy will focus on reducing inflammation and reducing glycaemia and insulinaemia while promoting nutrient-rich diet.

Patients will be taught how to prepare traditional Mediterranean meals (healthy, satiating, palatable and easy to prepare).

Patients in the control arm will not receive specific suggestions concerning diet, but standard healthy lifestyle recommendations will be given. The recommendations, including nutritional consultation if needed by standard practice of care, will be reinforced at each clinical visit and through a leaflet according to primary cancer prevention nutritional guidelines. Patients in the control group are encouraged to follow the WCRF/AICR recommendations but they will not receive any of the recipes or educational materials given to the intervention group.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Phase II Study for Tertiary Prevention of Squamocellular Cancer of Head and Neck (SCCHN) With a Dietary Intervention
Study Start Date : November 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental arm
The experimental arm is based on a dietary intervention in addition to standard recommendations.The diet will be based on the AICR/WCRF recommendations for cancer prevention and for the prevention of recurrences. The intervention strategy will focus on reducing inflammation and reducing glycaemia and insulinaemia while promoting nutrient-rich diet. Patients will be taught how to prepare traditional Mediterranean meals (healthy, satiating, palatable and easy to prepare).
Dietary Supplement: dietary intervention in addition to standard recommendations

The diet of the intervention group will be based on the AICR/WCRF recommendations for cancer prevention and for the prevention of recurrences (www.dietandcancerreport.org):

  • avoid or limit alcoholic drinks (2 drinks men, 1 drink women)
  • increase consumption of a variety of non-starchy vegetables, fruits (at least 400g per day) and dietary fibers (at least 25g per day)
  • eat mostly food of plant origin
  • eat lean meat, limit intake of red meat and avoid processed meat
  • increase consumption of anti-inflammatory foods, such as fish and whole grain cereals, f.e. brown rice and barley creams
  • avoid high glycaemic and high insulinemic foods, such as refined flours, white breads, and pastries

No Intervention: Control arm
Patients in the control arm will not receive specific suggestions concerning diet, but standard healthy lifestyle recommendations will be given. The recommendations, including nutritional consultation if needed by standard practice of care, will be reinforced at each clinical visit and through a leaflet according to primary cancer prevention nutritional guidelines. Patients in the control group will not receive any of the recipes or educational materials given to the intervention group and they will not have kitchen classes.



Primary Outcome Measures :
  1. Reduction in the incidence of tumor recurrence and second primaries [ Time Frame: 36 months ]
    Reduction in the incidence of tumor recurrence and second primaries will be assessed. When a clinical or radiological evidence of recurrence exists, all the efforts should be made in order to perform a histological confirmation. It is possible that a certain amount of recurrences will not be cyto/histologically confirmed due to tumor location not making the sampling feasible. It will be accepted a maximum percentage of 10% of such cases, if in presence of at least 2 different concordant radiological imaging.

  2. Identification of saliva and plasma miRNAs and evaluation of their change in the 2 arms of treatment [ Time Frame: 36 months ]
    The project involves the monitoring of miRNAs during the dietary intervention to ascertain the effectiveness of the treatment and the relationship with clinical outcome

  3. Change in inflammatory cytokine profile during the course of dietary intervention [ Time Frame: 36 months ]
    The change in inflammatory cytokine profile during the course of dietary intervention and the comparison with control arm will be evaluated


Secondary Outcome Measures :
  1. Reduction of treatment related side effects [ Time Frame: 36 months ]
    Reduction of treatment related side effects (e.g. xerostomia, fatigue, mucositis), assessed according to CTCAE v 4.0 (physician assessed symptoms) will be evaluated during study course.

  2. Quality of Life [ Time Frame: 36 months ]
    The improvement of Quality of Life assessed according to EORTC HN35 questionnaires (patient reported outcome) will be evaluated

  3. Identification of cytokine and growth factors [ Time Frame: 36 months ]
    Identification of cytokines and growth factors in blood and their change during the course of dietary intervention; comparison with control arm; Identification of tumor DNA in saliva and blood

  4. Monitoring of DNA methylation [ Time Frame: 36 months ]
    The monitoring of DNA methylation obtained from salivary rinses in the 2 groups will help to identify biomarkers associated to the outcome of the treatment



Information from the National Library of Medicine

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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:

  • 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

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): NCT02869399


Contacts
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Contact: Paolo Bossi, MD +39 022390 ext 2805 paolo.bossi@istitutotumori.mi.it
Contact: Roberta Granata, MD +39 022390 ext 2765 roberta.granata@istitutotumori.mi.it

Locations
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Austria
Medical University of Vienna Not yet recruiting
Vienna, Austria, 1090
Contact: Thorsten Füreder, MD    +4314040072750    thorsten.fuereder@meduniwien.ac.at   
Germany
Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde Recruiting
Leipzig, Germany, D-04103
Contact: Andreas Diets, MD    +49(0)341 9721700    Andreas.Dietz@medizin.uni-leipzig.de   
Contact: Gunnar Wichmann    ++49 (0) 341 97 21 926    Gunnar.Wichmann@medizin.uni-leipzig.de   
Italy
Fondazione IRCCS Istituto Nazionale Tumori Recruiting
Milan, Lombardy, Italy, 20133
Contact: Paolo Bossi, MD    +39 022390 ext 2805    paolo.bossi@istitutotumori.mi.it   
Contact: Roberta Granata, MD    +39 022390 ext 2765    roberta.granata@istitutotumori.mi.it   
Poland
The Greater Poland Cancer Centre Not yet recruiting
Poznań, Poland, 61-866
Contact: Wojciech Golusinski, MD    +48 61 8850 929    wgolus@ump.edu.pl   
Contact: Ewa Majchrzak, MD    (+48 61) 885 09 28    ewa.majchrzak@onet.eu   
Portugal
Grupo de Estudos de Cancro da Cabeça e Pescoço Not yet recruiting
Lisbon, Portugal
Contact: Ana Castro, MD    +351912342813    anafmferreira@yahoo.com   
Contact: Nelia Gouveia       neliagou@gmail.com   
Slovenia
Institute of Oncology Ljubljana Recruiting
Ljubljana, Slovenia, SI-1000
Contact: Primož Strojan, MD    +386 1 5879 290    pstrojan@onko-i.si   
Contact: Nada Rotovnik Kozjek       NKozjek@onko-i.si   
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: Lisa Licitra, MD Fondazione IRCCS Istituto Tumori Milano

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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02869399     History of Changes
Other Study ID Numbers: INT 18/15
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Abstracts and posters to National and International Congresses and results publication on idexes papers

Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
head and neck cancer, nutritional intervention

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms