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
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Head and Neck||Dietary Supplement: dietary intervention in addition to standard recommendations||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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):
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.
- 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.
- 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
- 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
- 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.
- 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
- 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
- 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
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
|Contact: Paolo Bossi, MD||+39 022390 ext firstname.lastname@example.org|
|Contact: Roberta Granata, MD||+39 022390 ext email@example.com|
|Medical University of Vienna||Not yet recruiting|
|Vienna, Austria, 1090|
|Contact: Thorsten Füreder, MD +4314040072750 firstname.lastname@example.org|
|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|
|Fondazione IRCCS Istituto Nazionale Tumori||Recruiting|
|Milan, Lombardy, Italy, 20133|
|Contact: Paolo Bossi, MD +39 022390 ext 2805 email@example.com|
|Contact: Roberta Granata, MD +39 022390 ext 2765 firstname.lastname@example.org|
|The Greater Poland Cancer Centre||Not yet recruiting|
|Poznań, Poland, 61-866|
|Contact: Wojciech Golusinski, MD +48 61 8850 929 email@example.com|
|Contact: Ewa Majchrzak, MD (+48 61) 885 09 28 firstname.lastname@example.org|
|Grupo de Estudos de Cancro da Cabeça e Pescoço||Not yet recruiting|
|Contact: Ana Castro, MD +351912342813 email@example.com|
|Contact: Nelia Gouveia firstname.lastname@example.org|
|Institute of Oncology Ljubljana||Recruiting|
|Ljubljana, Slovenia, SI-1000|
|Contact: Primož Strojan, MD +386 1 5879 290 email@example.com|
|Contact: Nada Rotovnik Kozjek NKozjek@onko-i.si|
|Principal Investigator:||Lisa Licitra, MD||Fondazione IRCCS Istituto Tumori Milano|