Head and Neck Squamous Cell CarcinomaGALENOS 2NCT07514754
Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients
A study testing Galenic Immunonutrition Formula in people with Head and Neck Squamous Cell Carcinoma and Locally Advanced Rectal Cancer, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
Trial summary
GALENOS 2 is a single-arm, single-center, phase II interventional study designed to evaluate the effects of a galenic immunonutrition dietary supplement in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Locally Advanced Rectal Cancer, Lung Cancer
- What is being tested?
- Galenic Immunonutrition Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 3 Oct 2025to 30 Dec 2027
- 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
- Written informed consent to study procedures
- Male or female, age greater than 18 years
- Histological or cytological documentation of head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer candidate for immunotherapy, chemotherapy, and/or radiotherapy according to standard clinical practice
- ECOG Performance Status score less than 2
- Adequate kidney, liver, and bone marrow function
- Ability to understand, sign informed consent, and comply with study procedures
Who cannot join
- Incomplete recovery from surgery before starting antineoplastic treatment
- Other progressing malignancy or malignancy requiring active treatment within the last 3 years, except localized basal cell carcinoma, localized squamous cell carcinoma of the skin, or cervical carcinoma in situ
- Active infection requiring systemic antibiotic therapy
- Serious or unstable medical conditions, psychiatric disorders, or substance abuse interfering with study compliance
- Receipt of any live vaccine within 30 days before study treatment
- Active cardiac pacing/pacing implants/neurostimulators/hearing system not compatible with bioimpedance analysis
- Edema and/or ascites not compatible with body weight evaluation and bioimpedance analysis
- Enteral or parenteral nutritional support at baseline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
Candiolo, Torino (TO), 10060
Valentina Casalone, 0119933844 ext. +39, valentina.casalone@ircc.it
About this study
Official title: Use of an Immunonutrition Galenic Formulation in Head and Neck, Lung and Rectal Cancer Patients During Antineoplastic Treatments: A Prospective Study
GALENOS 2 is a single-arm, single-center, phase II interventional study designed to evaluate the effects of a galenic immunonutrition dietary supplement in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment. The study aims to assess whether the formula may reduce treatment-related toxicity and improve treatment compliance, using patients from the GALENOS 1 observational study as the control group for comparison
Read the detailed description
This prospective interventional study will enroll adult patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard chemoradiotherapy, chemotherapy, radiotherapy, or immunotherapy according to clinical practice. All enrolled participants will receive a galenic immunonutrition formula twice daily starting on the first day of antineoplastic treatment and continuing for up to 45 days, in addition to standard nutritional counseling and routine oncologic care. The study will prospectively assess treatment-related toxicity, nutritional status, body composition, muscle function, cytokine profiles, quality of life, physical activity, treatment adherence/tolerance, and compliance with the galenic formula. Outcomes in GALENOS 2 will be compared with matched or pooled control patients from the GALENOS 1 observational study
- Being tested
- Galenic Immunonutrition Formula
- Keywords
- Immunonutrition, Head and Neck Squamous Cell Carcinoma, Locally Advanced Rectal Cancer, Lung Cancer, Treatment Toxicity, Supportive Care, Body Composition, Nutritional Status, Cytokines, Quality of Life
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galenic Immunonutrition FormulaDietary supplement
The investigational galenic immunonutrition formula is a jelly-based oral supplement formulated with arginine, brewer's yeast, omega-3 powder, olive oil, soy lecithin, glycerol, animal gelatine, purified water, citrate components, and flavoring, with sugar-containing or sweetener-containing versions and peach or lemon flavor options. Participants will receive two servings per day starting on the first day of antineoplastic treatment and continuing for up to 45 days. The product will be prepared and supplied free of charge by the Hospital Pharmacy of FPO-IRCCS Candiolo
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Galenic Immunonutrition Formula | Experimental | Participants with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment will receive the galenic immunonutrition formula twice daily from treatment start for a maximum of 45 days, alongside routine nutritional counseling and standard clinical management Receives: Dietary Supplement: Galenic Immunonutrition Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with at least 1 Grade 3 or higher treatment-related adverse event
Number of participants with at least 1 treatment-related adverse event of Grade 3 or higher, assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Measured: From the first day of antineoplastic treatment to end of trial, assessed up to 63 days
Secondary outcomes (43)
Body weight
Body weight measured in kilograms (kg)
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Body mass index
Body mass index calculated as body weight in kilograms divided by height in meters squared (kg/m²)
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Daily oral energy intake
Average daily oral energy intake assessed from food record and expressed in kilocalories per day (kcal/day).
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Nutritional Risk Screening 2002 score
Nutritional risk assessed using the Nutritional Risk Screening 2002 (NRS-2002). Total score ranges from 0 to 7, with higher scores indicating greater nutritional risk and worse nutritional status
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Prognostic Nutritional Index
Prognostic Nutritional Index (PNI). Higher values indicate better nutritional and immunologic status
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Participants requiring additional nutritional support
Number of participants requiring additional oral, enteral, or parenteral nutritional support during the study period
Measured: From the first day of treatment to end of trial, assessed up to 63 days
Skeletal muscle mass
Skeletal muscle mass measured by bioimpedance analysis and expressed in kilograms (kg)
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Fat-free mass
Fat-free mass measured by bioimpedance analysis and expressed in kilograms (kg).
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Body cell mass
Body cell mass measured by bioimpedance analysis and expressed in kilograms (kg).
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Fat mass
Fat mass measured by bioimpedance analysis and expressed in kilograms (kg).
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Total body water
Total body water measured by bioimpedance analysis and expressed in liters (L)
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Skeletal muscle index
Skeletal muscle index measured by bioimpedance analysis and expressed in kg/m²
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Phase angle
Phase angle measured by bioimpedance analysis and expressed in degrees. Higher values generally indicate better cellular integrity
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Handgrip strength
Maximum handgrip strength measured using a handgrip dynamometer and expressed in kilograms (kg).
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Handgrip endurance
Handgrip endurance measured using a handgrip dynamometer.
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
ECOG Performance Status score
Performance status assessed using the Eastern Cooperative Oncology Group (ECOG) Performance Status scale. Scores range from 0 to 5, with higher scores indicating worse functional impairment
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Toxicity-free survival
Time from the first day of antineoplastic treatment to the first documented treatment-related adverse event, assessed according to CTCAE v5.0, expressed in days
Measured: From the first day of treatment to first toxicity or end of trial, assessed up to 63 days
Relative chemotherapy dose delivered
Total chemotherapy dose administered expressed as the percentage of the planned chemotherapy dose
Measured: From treatment start to end of treatment, assessed up to 63 days
Relative radiotherapy dose delivered
Total radiotherapy dose administered expressed as the percentage of the planned radiotherapy dose.
Measured: From treatment start to end of treatment, assessed up to 63 days
Relative immunotherapy dose delivered
Total immunotherapy dose administered expressed as the percentage of the planned immunotherapy dose.
Measured: From treatment start to end of treatment, assessed up to 63 days
Relative variation in treatment duration
Variation in actual treatment duration compared with planned treatment duration, expressed as a percentage
Measured: From treatment start to end of treatment, assessed up to 63 days
Participants completing the planned treatment schedule
Number of participants who complete the planned treatment schedule.
Measured: From treatment start to end of treatment, assessed up to 63 days
Participants requiring unplanned hospitalization
Number of participants requiring at least 1 unplanned hospitalization during the study period.
Measured: From treatment start to end of trial, assessed up to 63 days
EORTC QLQ-C30 Global Health Status / Quality of Life score
Self-perceived quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 version 3.0 (EORTC QLQ-C30 v3.0), Global Health Status / Quality of Life scale. Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: At baseline (T0), during treatment, and at end of trial (T3), assessed up to 63 days
International Physical Activity Questionnaire score
Physical activity assessed using the International Physical Activity Questionnaire (IPAQ).
Measured: From baseline (T0) to end of trial (T3), assessed up to 63 days
Formula compliance
Compliance with the galenic immunonutrition formula, expressed as the percentage of prescribed daily servings recorded as consumed in the daily intake diary.
Measured: From the first day of treatment to Day 45, assessed up to 45 days
Change in circulating CCL2 concentration
Plasma CCL2 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating CCL4 concentration
Plasma CCL4 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating CCL22 concentration
Plasma CCL22 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating CXCL10 concentration
Plasma CXCL10 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IFN-γ concentration
Plasma IFN-γ concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-2 concentration
Plasma IL-2 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-4 concentration
Plasma IL-4 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-5 concentration
Plasma IL-5 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-6 concentration
Plasma IL-6 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-8 concentration
Plasma IL-8 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-10 concentration
Plasma IL-10 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-12 concentration
Plasma IL-12 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-13 concentration
Plasma IL-13 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-15 concentration
Plasma IL-15 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating TGF-β concentration
Plasma TGF-β concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating TNF-α concentration
Plasma TNF-α concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in C-reactive protein concentration
C-reactive protein concentration measured in peripheral blood
Measured: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start3 Oct 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive the galenic immunonutrition formula in addition to standard nutritional care and standard oncologic treatment. Outcomes will be compared with control patients from the GALENOS 1 observational study using matching or pooling methods
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514754
- Sponsor's protocol ID
- 006-FPO25
- Acronym
- GALENOS 2
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Immunonutrition Galenic Formulation in Head and Neck, Lung and Rectal Cancer Patients During Antineoplastic Treatments: A Prospective Study
- ClinicalTrials.gov ID
- NCT07514754
- Acronym / sponsor ID
- GALENOS 2 / 006-FPO25
- Keywords
- Immunonutrition, Head and Neck Squamous Cell Carcinoma, Locally Advanced Rectal Cancer, Lung Cancer, Treatment Toxicity, Supportive Care, Body Composition, Nutritional Status
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- 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.
GALENOS 2 is a single-arm, single-center, phase II interventional study designed to evaluate the effects of a galenic immunonutrition dietary supplement in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment. The study aims to assess whether the formula may reduce treatment-related toxicity and improve treatment compliance, using patients from the GALENOS 1 observational study as the control group for comparison
Detailed description
This prospective interventional study will enroll adult patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard chemoradiotherapy, chemotherapy, radiotherapy, or immunotherapy according to clinical practice. All enrolled participants will receive a galenic immunonutrition formula twice daily starting on the first day of antineoplastic treatment and continuing for up to 45 days, in addition to standard nutritional counseling and routine oncologic care. The study will prospectively assess treatment-related toxicity, nutritional status, body composition, muscle function, cytokine profiles, quality of life, physical activity, treatment adherence/tolerance, and compliance with the galenic formula. Outcomes in GALENOS 2 will be compared with matched or pooled control patients from the GALENOS 1 observational study
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive the galenic immunonutrition formula in addition to standard nutritional care and standard oncologic treatment. Outcomes will be compared with control patients from the GALENOS 1 observational study using matching or pooling methods
| Arm | Type | Receives |
|---|---|---|
| Experimental: Galenic Immunonutrition Formula | Experimental | Dietary Supplement: Galenic Immunonutrition FormulaParticipants with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment will receive the galenic immunonutrition formula twice daily from treatment start for a maximum of 45 days, alongside routine nutritional counseling and standard clinical management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent to study procedures
- Male or female, age greater than 18 years
- Histological or cytological documentation of head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer candidate for immunotherapy, chemotherapy, and/or radiotherapy according to standard clinical practice
- ECOG Performance Status score less than 2
- Adequate kidney, liver, and bone marrow function
Key exclusion criteria (8 listed)
- Incomplete recovery from surgery before starting antineoplastic treatment
- Other progressing malignancy or malignancy requiring active treatment within the last 3 years, except localized basal cell carcinoma, localized squamous cell carcinoma of the skin, or cervical carcinoma in situ
- Active infection requiring systemic antibiotic therapy
- Serious or unstable medical conditions, psychiatric disorders, or substance abuse interfering with study compliance
- Receipt of any live vaccine within 30 days before study treatment
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 |
|---|---|---|
| Galenic Immunonutrition FormulaThe investigational galenic immunonutrition formula is a jelly-based oral supplement formulated with arginine, brewer's yeast, omega-3 powder, olive oil, soy lecithin, glycerol, animal gelatine, purified water, citrate components, and flavoring, with sugar-containing or sweetener-containing versions and peach or lemon flavor options. Participants will receive two servings per day starting on the first day of antineoplastic treatment and continuing for up to 45 days. The product will be prepared and supplied free of charge by the Hospital Pharmacy of FPO-IRCCS Candiolo | Dietary supplement | Experimental: Galenic Immunonutrition Formula |
Primary outcome
Participants with at least 1 Grade 3 or higher treatment-related adverse event
Time frame: From the first day of antineoplastic treatment to end of trial, assessed up to 63 days
Number of participants with at least 1 treatment-related adverse event of Grade 3 or higher, assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
43 secondary outcomes
Body weight
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Body mass index
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Daily oral energy intake
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Nutritional Risk Screening 2002 score
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Prognostic Nutritional Index
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Participants requiring additional nutritional support
Time frame: From the first day of treatment to end of trial, assessed up to 63 days
Skeletal muscle mass
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Fat-free mass
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Body cell mass
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Fat mass
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Total body water
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Skeletal muscle index
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Phase angle
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Handgrip strength
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Handgrip endurance
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
ECOG Performance Status score
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Toxicity-free survival
Time frame: From the first day of treatment to first toxicity or end of trial, assessed up to 63 days
Relative chemotherapy dose delivered
Time frame: From treatment start to end of treatment, assessed up to 63 days
Relative radiotherapy dose delivered
Time frame: From treatment start to end of treatment, assessed up to 63 days
Relative immunotherapy dose delivered
Time frame: From treatment start to end of treatment, assessed up to 63 days
Relative variation in treatment duration
Time frame: From treatment start to end of treatment, assessed up to 63 days
Participants completing the planned treatment schedule
Time frame: From treatment start to end of treatment, assessed up to 63 days
Participants requiring unplanned hospitalization
Time frame: From treatment start to end of trial, assessed up to 63 days
EORTC QLQ-C30 Global Health Status / Quality of Life score
Time frame: At baseline (T0), during treatment, and at end of trial (T3), assessed up to 63 days
International Physical Activity Questionnaire score
Time frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Formula compliance
Time frame: From the first day of treatment to Day 45, assessed up to 45 days
Change in circulating CCL2 concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating CCL4 concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating CCL22 concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating CXCL10 concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IFN-γ concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-2 concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-4 concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-5 concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-6 concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-8 concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-10 concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-12 concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-13 concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-15 concentration
Time frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galenic Immunonutrition Formula in people with Head and Neck Squamous Cell Carcinoma and Locally Advanced Rectal Cancer, run by Fondazione del Piemonte per l'Oncologia 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 6 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. 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 Valentina Casalone, MD (0119933844 ext. +39, valentina.casalone@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with at least 1 Grade 3 or higher treatment-related adverse event (time frame: From the first day of antineoplastic treatment to end of trial, assessed up to 63 days). 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 7 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.