GALENOS 1 in Head and Neck, Lung, and Rectal Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione del Piemonte per l'Oncologia
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
110 Participants
are grouped into 3 trial groupsGroup A: Head and Neck Squamous Cell Carcinoma Cohort
Group B: Locally Advanced Rectal Cancer Cohort
Group C: Lung Cancer Cohort
Trial outcomes
Primary outcomes
1
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)
Time frame
From baseline (T0, first day of antineoplastic treatment) to end of treatment/final follow-up, assessed up to approximately 3 months2
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
Time frame
From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months3
Handgrip strength
Maximum handgrip strength measured using a handgrip dynamometer and expressed in kilograms (kg)
Time frame
From baseline (T0) to final follow-up (T4), assessed up to approximately 3 monthsSecondary outcomes
1
Body weight
Body weight measured in kilograms (kg)
Time frame
From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months2
Participants with more than 5% body weight loss
Number of participants with body weight loss greater than 5% from baseline
Time frame
From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months3
Body mass index
Body mass index calculated as body weight in kilograms divided by height in meters squared (kg/m²)
Time frame
From baseline (T0) to final follow-up (T4), assessed up to approximately 3 months4
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
Time frame
From baseline (T0) to final follow-up (T4), assessed up to approximately 3 monthsOther outcomes
1
Change in C-reactive protein concentration
C-reactive protein concentration measured in peripheral blood
Time frame
From baseline (T0) to end of antineoplastic treatment (T3), assessed up to approximately 6 to 7 weeksSponsors and contacts
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Source ClinicalTrials.gov