Ignite Creation Date:
2024-05-06 @ 8:57 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02869399
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2016-08-11
Brief Title:
Tertiary Prevention of Head and Neck Cancer With a Dietary Intervention
Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Organization:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Study Overview
Official Title:
A Randomized Phase II Study for Tertiary Prevention of Squamocellular Cancer of Head and Neck SCCHN With a Dietary Intervention
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DietINT
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 AICRWCRF 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-HN35 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
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 40 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 WCRFAICR recommendations but they will not receive any of the recipes or educational materials given to the intervention group
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 40 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 WCRFAICR recommendations but they will not receive any of the recipes or educational materials given to the intervention group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None