Head and Neck Squamous Cell CarcinomaGALENOS 1NCT07511413
GALENOS 1 in Head and Neck, Lung, and Rectal Cancer Patients
An observational study of 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 1 is a prospective observational study designed to explore longitudinal changes in nutritional status and body composition in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, and lung cancer undergoing standard antineoplastic treatments. 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
- Type of treatment
- Pill or oral medicine
- How many people
- 110 participants
- Where
- 1 siteItaly
- Study dates
- 23 Sep 2024to 30 Dec 2027
- Phase
- Observational
- 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
Study population: Adult patients with histologically or cytologically documented head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard antineoplastic treatment at Fondazione del Piemonte per l'Oncologia - IRCCS Candiolo and meet protocol eligibility criteria
Who may be able to join
- Written informed consent provided before study procedures
- Male or female participants aged 18 years or older
- Histological or cytological documentation of head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer
- Candidate for standard antineoplastic treatment according to clinical practice
- ECOG Performance Status score less than 2
- Adequate kidney, liver, and bone marrow function
- Ability to adhere to study visits and protocol requirements
Who cannot join
- Incomplete recovery from surgery before start of antineoplastic treatment
- Other additional malignancies progressing or requiring active treatment within the previous 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 that would interfere with study compliance
- Receipt of any live vaccine within 30 days before planned start of study therapy
- Active cardiac pacing/pacing implants/neurostimulators/hearing systems not compatible with bioimpedance analysis
- Edema and/or ascites interfering with body weight evaluation or 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, MD, 0119933422, valentina.casalone@ircc.it
About this study
Official title: An Observational Study on Longitudinal Nutritional Status and Body Composition Changes in Head and Neck Cancer, Lung Cancer and Rectal Cancer Patients During Antineoplastic Treatments
GALENOS 1 is a prospective observational study designed to explore longitudinal changes in nutritional status and body composition in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, and lung cancer undergoing standard antineoplastic treatments. The study is the preparatory observational component of the FOR-GALE PREVENTION project, which aims to support the future development of a galenic immunonutrition dietary supplement intended to reduce adverse events and improve treatment compliance
Read the detailed description
This single-center prospective observational cohort study will enroll adult patients with pathologically confirmed head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard antineoplastic treatment according to routine clinical practice. The study will longitudinally assess nutritional intake, anthropometric and body composition parameters, muscle function, circulating cytokines, quality of life, treatment-related toxicity, and treatment tolerance. Study procedures include dietary visits, 3-day food records, nutritional screening, bioimpedance analysis, handgrip testing, cytokine sampling, quality-of-life questionnaires, and collection of treatment adherence/tolerance data at predefined time points from baseline through follow-up. The study aims to generate observational data to inform future immunonutritional interventional studies
- Keywords
- Head and Neck Squamous Cell Carcinoma, Lung Cancer, Locally Advanced Rectal Cancer, Nutritional Status, Body Composition, Skeletal Muscle Mass, Sarcopenia, Bioimpedance Analysis, Handgrip Strength, Cytokines, Quality of Life, Treatment Toxicity, Treatment Tolerance, Immunonutrition, Supportive Care
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Lung Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck Squamous Cell Carcinoma Cohort | Patients with pathologically confirmed head and neck squamous cell carcinoma (oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, or sinus cancer) who are candidates for curative or adjuvant chemoradiotherapy according to standard clinical practice | |
| Locally Advanced Rectal Cancer Cohort | Patients with pathologically confirmed locally advanced rectal cancer who are candidates for neoadjuvant chemoradiotherapy according to standard clinical practice | |
| Lung Cancer Cohort | Patients with pathologically or cytologically confirmed lung cancer who are candidates for curative immunotherapy with or without chemotherapy according to standard clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily energy intake normalized to body weight
Average daily oral energy intake assessed using a 3-day food record and expressed as kilocalories per kilogram of body weight per day (kcal/kg/day)
Measured: From baseline (T0, first day of antineoplastic treatment) to end of treatment/final follow-up, assessed up to approximately 3 months
Skeletal muscle mass
Skeletal muscle mass measured by bioimpedance analysis and expressed in kilograms (kg) the protocol states that phase angle may be used as an alternative depending on the BIA software
Measured: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Handgrip strength
Maximum handgrip strength measured using a handgrip dynamometer and expressed in kilograms (kg)
Measured: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Secondary outcomes (28)
Body weight
Body weight measured in kilograms (kg)
Measured: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Participants with more than 5% body weight loss
Number of participants with body weight loss greater than 5% from baseline
Measured: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
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 final follow-up (T4), assessed up to approximately 3 months
Nutritional Risk Screening 2002 score
Nutritional risk assessed using the Nutritional Risk Screening 2002 (NRS-2002). Total scores range from 0 to 7, with higher scores indicating greater nutritional risk and worse nutritional status
Measured: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Prognostic Nutritional Index
Prognostic Nutritional Index calculated as serum albumin + 5 × total lymphocyte count. Higher values indicate better nutritional/immunologic status
Measured: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Phase angle
Phase angle measured by bioimpedance analysis and expressed in degrees. Higher values generally indicate better cellular integrity and nutritional status
Measured: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Fat-free mass
Fat-free mass measured by bioimpedance analysis and expressed in kilograms (kg)
Measured: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Body cell mass
Body cell mass measured by bioimpedance analysis and expressed in kilograms (kg)
Measured: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Fat mass
Fat mass measured by bioimpedance analysis and expressed in kilograms (kg)
Measured: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Total body water
Total body water measured by bioimpedance analysis and expressed in liters (L)
Measured: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
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 global health status and quality of life.
Measured: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating VEGF concentration
Plasma VEGF concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL
Measured: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start23 Sep 2024
- Primary completion30 Aug 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 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
- NCT07511413
- Sponsor's protocol ID
- 003-FPO24
- Acronym
- GALENOS 1
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on Longitudinal Nutritional Status and Body Composition Changes in Head and Neck Cancer, Lung Cancer and Rectal Cancer Patients During Antineoplastic Treatments
- ClinicalTrials.gov ID
- NCT07511413
- Acronym / sponsor ID
- GALENOS 1 / 003-FPO24
- Keywords
- Head and Neck Squamous Cell Carcinoma, Lung Cancer, Locally Advanced Rectal Cancer, Nutritional Status, Body Composition, Skeletal Muscle Mass, Sarcopenia, Bioimpedance Analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 6 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 1 is a prospective observational study designed to explore longitudinal changes in nutritional status and body composition in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, and lung cancer undergoing standard antineoplastic treatments. The study is the preparatory observational component of the FOR-GALE PREVENTION project, which aims to support the future development of a galenic immunonutrition dietary supplement intended to reduce adverse events and improve treatment compliance
Detailed description
This single-center prospective observational cohort study will enroll adult patients with pathologically confirmed head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard antineoplastic treatment according to routine clinical practice. The study will longitudinally assess nutritional intake, anthropometric and body composition parameters, muscle function, circulating cytokines, quality of life, treatment-related toxicity, and treatment tolerance. Study procedures include dietary visits, 3-day food records, nutritional screening, bioimpedance analysis, handgrip testing, cytokine sampling, quality-of-life questionnaires, and collection of treatment adherence/tolerance data at predefined time points from baseline through follow-up. The study aims to generate observational data to inform future immunonutritional interventional studies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Squamous Cell Carcinoma Cohort | – | –Patients with pathologically confirmed head and neck squamous cell carcinoma (oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, or sinus cancer) who are candidates for curative or adjuvant chemoradiotherapy according to standard clinical practice |
| Locally Advanced Rectal Cancer Cohort | – | –Patients with pathologically confirmed locally advanced rectal cancer who are candidates for neoadjuvant chemoradiotherapy according to standard clinical practice |
| Lung Cancer Cohort | – | –Patients with pathologically or cytologically confirmed lung cancer who are candidates for curative immunotherapy with or without chemotherapy according to standard clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with histologically or cytologically documented head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard antineoplastic treatment at Fondazione del Piemonte per l'Oncologia - IRCCS Candiolo and meet protocol eligibility criteria
Key inclusion criteria (7 listed)
- Written informed consent provided before study procedures
- Male or female participants aged 18 years or older
- Histological or cytological documentation of head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer
- Candidate for standard antineoplastic treatment according to clinical practice
- ECOG Performance Status score less than 2
Key exclusion criteria (7 listed)
- Incomplete recovery from surgery before start of antineoplastic treatment
- Other additional malignancies progressing or requiring active treatment within the previous 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 that would interfere with study compliance
- Receipt of any live vaccine within 30 days before planned start of study therapy
- Active cardiac pacing/pacing implants/neurostimulators/hearing systems not compatible with bioimpedance analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Daily energy intake normalized to body weight
Time frame: From baseline (T0, first day of antineoplastic treatment) to end of treatment/final follow-up, assessed up to approximately 3 months
Average daily oral energy intake assessed using a 3-day food record and expressed as kilocalories per kilogram of body weight per day (kcal/kg/day)
Skeletal muscle mass
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Skeletal muscle mass measured by bioimpedance analysis and expressed in kilograms (kg) the protocol states that phase angle may be used as an alternative depending on the BIA software
Handgrip strength
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Maximum handgrip strength measured using a handgrip dynamometer and expressed in kilograms (kg)
28 secondary outcomes
Body weight
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Participants with more than 5% body weight loss
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Body mass index
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Nutritional Risk Screening 2002 score
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Prognostic Nutritional Index
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Phase angle
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Fat-free mass
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Body cell mass
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Fat mass
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Total body water
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
EORTC QLQ-C30 Global Health Status / Quality of Life score
Time frame: From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months
Change in circulating CCL2 concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating CCL4 concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating CCL22 concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating CXCL10 concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating IL-2 concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating IL-4 concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating IL-5 concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating IL-6 concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating IL-8 concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating IL-10 concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating IL-12 concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating IL-15 concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating IL-13 concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating TNF-α concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating IFN-γ concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating VEGF concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
Change in circulating TGF-β concentration
Time frame: From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeks
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 6 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of 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 7 inclusion and 7 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 6 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 (0119933422 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?
Daily energy intake normalized to body weight (time frame: From baseline (T0, first day of antineoplastic treatment) to end of treatment/final follow-up, assessed up to approximately 3 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 6 Apr 2026.