Cancer of Head and NeckDietINTNCT02869399
Tertiary Prevention of Head and Neck Cancer With a Dietary Intervention
A study testing dietary intervention in addition to standard recommendations in people with Cancer of Head and Neck, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- dietary intervention in addition to standard recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Nov 2015to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Germany1 site
Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde
Leipzig, D-04103
About this study
Official title: A Randomized Phase II Study for Tertiary Prevention of Squamocellular Cancer of Head and Neck (SCCHN) With a Dietary Intervention
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.
Read the 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.
- Conditions
- Cancer of Head and Neck
- Being tested
- dietary intervention in addition to standard recommendations
- Keywords
- head and neck cancer, nutritional intervention
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary intervention in addition to standard recommendationsDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 36 months
Secondary outcomes (4)
Reduction of treatment related side effects
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.
Measured: 36 months
EORTC HN35 quality of life scales
The improvement of Quality of Life assessed according to EORTC HN35 questionnaires (patient reported outcome) will be evaluated
Measured: 36 months
Identification of cytokine and growth factors
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
Measured: 36 months
Monitoring of DNA methylation
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2018
- Study completionFeb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Licitra, MD, Principal investigator, Fondazione IRCCS Istituto Tumori Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869399
- Sponsor's protocol ID
- INT 18/15
- Acronym
- DietINT
- Status last verified
- Apr 2022
- First submitted
- 11 Aug 2016
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The final results of the clinical study will be published in an impacted scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study for Tertiary Prevention of Squamocellular Cancer of Head and Neck (SCCHN) With a Dietary Intervention
- ClinicalTrials.gov ID
- NCT02869399
- Acronym / sponsor ID
- DietINT / INT 18/15
- Conditions
- Cancer of Head and Neck
- Keywords
- head and neck cancer, nutritional intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2018 (actual)
- Study completion
- Feb 2023 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Dietary Supplement: dietary intervention in addition to standard recommendationsThe 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). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary intervention in addition to standard recommendationsThe 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 | Dietary supplement | Experimental arm |
Primary outcome
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
4 secondary outcomes
Reduction of treatment related side effects
Time frame: 36 months
EORTC HN35 quality of life scales
Time frame: 36 months
Identification of cytokine and growth factors
Time frame: 36 months
Monitoring of DNA methylation
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No. The final results of the clinical study will be published in an impacted scientific journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Licitra, MD principal investigator
Fondazione IRCCS Istituto Tumori Milano
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary intervention in addition to standard recommendations in people with Cancer of Head and Neck, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria, Germany, Italy, Poland, Portugal and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the incidence of tumor recurrence and second primaries (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.