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Head and Neck CancerNCT04611113

Immunonutrition and Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer

A study testing Immunonutrition in people with Head and Neck Cancer, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of the present project is to evaluate in a randomised, controlled, open-label, two parallel treatment groups pilot study, the efficacy of oral nutritional supplementation with a high-protein-high calorie mixture containing immunonutrients compared to a standard high-calorie-high-protein nutritional blend, in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Immunonutrition
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteItaly
Study dates
17 Mar 2021to 15 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • diagnosis of head-neck cancer
  • indication to curative or adjuvant chemoradiotherapy
  • availability to planned measurements and to written informed consent.

Who cannot join

  • age <18 years
  • indication to or ongoing artificial nutrition
  • refusal

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Riccardo Caccialanza, MD contact

0382501615 ext. +39

r.caccialanza@smatteo.pv.it

Emanuele Cereda, MD contact

0382501615 ext. +39

e.cereda@smatteo.pv.it

Italy1 site, 1 recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Riccardo Caccialanza, MD

    Riccardo Caccialanza, MD

    Recruiting

Other trials in Italy

About this study

Official title: Efficacy of Immunonutrition in Improving Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer

The aim of the present project is to evaluate in a randomised, controlled, open-label, two parallel treatment groups pilot study, the efficacy of oral nutritional supplementation with a high-protein-high calorie mixture containing immunonutrients compared to a standard high-calorie-high-protein nutritional blend, in addition to nutritional counseling, in improving tolerance to chemoradiotherapy (CT-RT) in patients with tumours of the head and neck

Read the detailed description

In a recent study, we have shown that the systematic use of oral nutritional supplements (ONS) in combination with counseling further favours the maintenance of nutrition status, the recovery of quality of life and, more importantly, improves the practicability of CT-RT. This effect would be substantially attributable to the increase in protein-energy intake associated with ONS use, but also to the possible "nutraceutical" action of omega-3 fatty acids. Therefore, modulation of the inflammatory response could play a role during cancer treatments. In this context, there is an already-known high-calorie-high-protein nutritional blend, enriched in immunonutrients (arginine, nucleotides and omega-3 fatty acids), which could also have an application in this type of patients. This mixture has proven effective in reducing the risk of post-operative complications (e.g. infections, fistulas, etc.) and the length of stay of patients undergoing major cancer surgery (abdominal and head and neck regions). Nevertheless, in oncology, there is a growing therapeutic interest in the modulation of inflammation and immunosuppression at the tumour microenvironment level.

Being tested
Immunonutrition, Control Nutritional Support
Keywords
Immunonutrition, Chemoradiotherapy, Treatment tolerance, Nutritional counseling
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.

  • ImmunonutritionDietary supplement

    In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement enriched in immunonutrients (Impact®). The intervention will start 10-15 days before anticancer treatment initiation and will continue until treatment termination or dropout.

  • Control Nutritional SupportDietary supplement

    In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement. The intervention will start 10-15 days before anticancer treatment initiation and will continue until treatment termination or dropout.

Study groups in NCT04611113
Study groupRoleWhat they receive
ImmunonutritionExperimentalIn addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement enriched in immunonutrients (Impact®). The intervention will start 10-15 days before anticancer treatment initiation and will continue until treatment termination or dropout.
Receives: Dietary Supplement: Immunonutrition
Control nutritional supportActive comparatorIn addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement. The intervention will start 10-15 days before anticancer treatment initiation and will continue until treatment termination or dropout.
Receives: Dietary Supplement: Control Nutritional Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]

    Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0

    Measured: 9 weeks

Secondary outcomes (14)

  1. Total chemotherapy dose

    To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan

    Measured: 9 weeks

  2. Total radiotherapy dose

    To be calculated as the percentage of radiotherapy dose administered with respect to the treatment plan

    Measured: 9 weeks

  3. Duration of treatment

    To be calculated as the percentage of variation of the duration of the chemotherapy and radiotherapy compared to the planned duration

    Measured: 9 weeks

  4. Toxicity-free survival

    Difference in the time to onset of moderate-severe adverse events as assessed by CTCAE v5.0

    Measured: 9 weeks

  5. Adherence to treatment schedule

    Difference in the proportion of patients completing the treatment schedule as planned

    Measured: 9 weeks

  6. Treatment-related adverse events as assessed by CTCAE v5.0

    Difference in the incidence of any toxicity, according to Common Terminology Criteria for Adverse Events [CTCAE v5.0]

    Measured: 9 weeks

  7. Objective response rate

    Defined as a complete response or partial response confirmed by a subsequent assessment no earlier than 2 months after the initial documentation. Response is assessed in patients with a measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) criteria

    Measured: 9 weeks

  8. Body weight

    Change in body weight during the study

    Measured: 9 weeks

  9. Energy intake

    Change in energy intake during the study

    Measured: 9 weeks

  10. Handgrip strength

    Change in handgrip strength during the study

    Measured: 9 weeks

  11. Skeletal muscle mass

    Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans (C3)

    Measured: 9 weeks

  12. Self-perceived quality of life

    Change in quality of life during the study as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 [EORTC QLQ-C30]

    Measured: 9 weeks

  13. Fatigue

    Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire

    Measured: 9 weeks

  14. Patients requiring unplanned hospitalization

    The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated

    Measured: 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2020
  2. Study start17 Mar 2021
  3. Primary completion15 Nov 2026 (estimated)
  4. Study completion15 Nov 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04611113
Sponsor's protocol ID
20200060578
Status last verified
Apr 2025
First submitted
21 Oct 2020
Last updated
1 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Depending on a specific research question and according to a study protocol to be approved by the Ethics Committee

Publications

  • Cereda E, Cappello S, Colombo S, Klersy C, Imarisio I, Turri A, Caraccia M, Borioli V, Monaco T, Benazzo M, Pedrazzoli P, Corbella F, Caccialanza R. Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy. Radiother Oncol. 2018 Jan;126(1):81-88. doi: 10.1016/j.radonc.2017.10.015. Epub 2017 Oct 27.

    PubMed 29111172

  • Boisselier P, Kaminsky MC, Thezenas S, Gallocher O, Lavau-Denes S, Garcia-Ramirez M, Alfonsi M, Cupissol D, de Forges H, Janiszewski C, Geoffrois L, Sire C, Senesse P; Head and Neck Oncology and Radiotherapy Group (GORTEC). A double-blind phase III trial of immunomodulating nutritional formula during adjuvant chemoradiotherapy in head and neck cancer patients: IMPATOX. Am J Clin Nutr. 2020 Dec 10;112(6):1523-1531. doi: 10.1093/ajcn/nqaa227.

    PubMed 32936874

  • Caccialanza R, Cereda E, Klersy C, Nardi M, Masi S, Crotti S, Cappello S, Caissutti V, Brovia C, Lobascio F, Formisano E, Colombo S, Filippi AR, Bonzano E, Comoli P, Catenacci L, Alberti A, Musella V, Ferrari A, Imarisio I, Tancredi R, Monaco T, Ghi MG, Bossi P, Pedrazzoli P. The efficacy of immunonutrition in improving tolerance to chemoradiotherapy in patients with head and neck cancer, receiving nutritional counseling: study protocol of a randomized, open-label, parallel group, bicentric pilot study. Ther Adv Med Oncol. 2021 Sep 11;13:17588359211025872. doi: 10.1177/17588359211025872. eCollection 2021.

    PubMed 34527079

Questions about this trial

What is this clinical trial studying?

A study testing Immunonutrition in people with Head and Neck Cancer, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Riccardo Caccialanza, MD (0382501615 ext. +39, r.caccialanza@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0] (time frame: 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04611113, which also lists 3 linked publications.

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 1 May 2025.

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