NCT Number: NCT04611113
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Pavia, 27100, Italy
Location status: Recruiting
Emanuele Cereda, MD, PhD
SUB_INVESTIGATOR
Paolo Pedrazzoli, MD
SUB_INVESTIGATOR
Riccardo Caccialanza, MD
CONTACT
Riccardo Caccialanza, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 9 weeks
Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0
Time frame: 9 weeks
To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan
Time frame: 9 weeks
To be calculated as the percentage of radiotherapy dose administered with respect to the treatment plan
Time frame: 9 weeks
To be calculated as the percentage of variation of the duration of the chemotherapy and radiotherapy compared to the planned duration
Time frame: 9 weeks
Difference in the time to onset of moderate-severe adverse events as assessed by CTCAE v5.0
Time frame: 9 weeks
Difference in the proportion of patients completing the treatment schedule as planned
Time frame: 9 weeks
Difference in the incidence of any toxicity, according to Common Terminology Criteria for Adverse Events [CTCAE v5.0]
Time frame: 9 weeks
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
Time frame: 9 weeks
Change in body weight during the study
Time frame: 9 weeks
Change in energy intake during the study
Time frame: 9 weeks
Change in handgrip strength during the study
Time frame: 9 weeks
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans (C3)
Time frame: 9 weeks
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]
Time frame: 9 weeks
Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire
Time frame: 9 weeks
The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated
Time frame: 9 weeks
Change in levels of soluble effectors and immuno-regulatory cells during the study
Contact information is provided by the study sponsor or research team.
Emanuele Cereda, MD
CONTACT
0382501615 ext. +39
Riccardo Caccialanza, MD
CONTACT
0382501615 ext. +39
Fondazione IRCCS Policlinico San Matteo di Pavia
Other
Efficacy of Immunonutrition in Improving Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer
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