Tertiary Prevention of Head and Neck Cancer With a Dietary Intervention

NCT02869399 | Completed

• 1 other identifier: INT 18/15
• Study Type: interventional
• Target: 94
• Locations: 6 countries
• Sites: 6

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.

Conditions

Cancer of Head and Neck

Keywords

head and neck cancer, nutritional intervention

Outcome Measures

Primary Outcomes (3)

• Reduction in the incidence of tumor recurrence and second primaries

  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.

  36 months

• Identification of saliva and plasma miRNAs and evaluation of their change in the 2 arms of treatment

  The project involves the monitoring of miRNAs during the dietary intervention to ascertain the effectiveness of the treatment and the relationship with clinical outcome

  36 months

• Change in inflammatory cytokine profile during the course of dietary intervention

  The change in inflammatory cytokine profile during the course of dietary intervention and the comparison with control arm will be evaluated

  36 months

Secondary Outcomes (4)

• Reduction of treatment related side effects

  36 months

• EORTC HN35 quality of life scales

  36 months

• Identification of cytokine and growth factors

  36 months

• Monitoring of DNA methylation

  36 months

Study Arms (2)

Experimental arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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.

Interventions

dietary intervention in addition to standard recommendations DIETARY_SUPPLEMENT

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

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (6)

Medical University of Vienna

Vienna, 1090, Austria

Location

Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde

Leipzig, D-04103, Germany

Location

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Lombardy, 20133, Italy

Location

The Greater Poland Cancer Centre

Poznan, 61-866, Poland

Location

Grupo de Estudos de Cancro da Cabeça e Pescoço

Lisbon, Portugal

Location

Institute of Oncology Ljubljana

Ljubljana, SI-1000, Slovenia

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Lisa Licitra, MD

  Fondazione IRCCS Istituto Tumori Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 17, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: February 1, 2023
• Last Updated: March 13, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); AU (1); IT (1); SL (1); PL (1); PT (1)