Actively Recruiting
An Observational Study on Nutritional and Body Composition Changes in Head and Neck, Lung, and Rectal Cancer Patients During Standard Treatments
Led by Fondazione del Piemonte per l'Oncologia · Updated on 2026-04-06
110
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, and lung cancer who are receiving standard cancer treatments. The study aims to observe changes in nutrition and body composition over time in these patients. This observational study supports the development of a future dietary supplement designed to reduce side effects and help patients better tolerate their cancer treatments. Participants will undergo regular assessments including dietary visits, 3-day food records, nutritional screenings, body composition analysis using bioimpedance, muscle strength tests with handgrip, blood sampling for cytokines, and quality-of-life questionnaires. These evaluations will be done at specific time points from the start of treatment through follow-up, up to approximately three months. During the study, researchers will collect data on energy intake, muscle mass, handgrip strength, body weight, nutritional risk, and inflammatory markers in the blood. They will also monitor treatment toxicity and tolerance. This comprehensive monitoring includes questionnaires and physical measurements to understand how patients' nutrition and body composition evolve during cancer treatment, helping to inform future supportive nutrition research.
CONDITIONS
Brief Title
GALENOS 1 in Head and Neck, Lung, and Rectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent before study procedures
- Male or female aged 18 years or older
- Histological or cytological confirmation 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
You will not qualify if you...
- Incomplete recovery from surgery before starting antineoplastic treatment
- Other active malignancies requiring treatment within the past 3 years, except certain localized skin cancers and cervical carcinoma in situ
- Active infection needing systemic antibiotics
- Serious or unstable medical or psychiatric conditions or substance abuse interfering with study compliance
- Receipt of any live vaccine within 30 days before planned study therapy start
- Active cardiac devices or implants incompatible with bioimpedance analysis
- Edema or ascites affecting body weight or bioimpedance assessments
- Receiving enteral or parenteral nutritional support at baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 to 7 weeks
Participants undergoing standard antineoplastic treatment are observed to assess nutritional intake, body composition, muscle function, circulating cytokines, quality of life, treatment-related toxicity, and treatment tolerance.
Multiple assessments including dietary visits, bioimpedance analysis, handgrip testing, cytokine sampling, and quality-of-life questionnaires at predefined time points during treatment
Duration - Up to approximately 3 months from baseline
Participants continue to be observed after treatment to evaluate changes in body composition, nutritional status, muscle strength, and quality of life.
Follow-up visits with repeated assessments of body composition, nutritional intake, and quality of life
Trial Site Locations
Total: 1 location
1
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
Candiolo, Torino (TO), Italy, 10060
Actively Recruiting
Research Team
V
Valentina Casalone, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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