Abstract 925TiP
Background
Nutritional support, including nutritional counseling and oral nutritional supplements (ONS), has been recommended at the earliest opportunity in head and neck (H&N) cancer patients. The limited available evidence on the efficacy of immunonutrition during chemoradiotherapy (CT-RT) in H&N cancer patients is positive with regards to some secondary endpoints, but is still scanty, particularly with regards to toxicity and treatment tolerance.
Trial Design: This is a pragmatic, bicentric, randomized (1:1), parallel-group, open label, controlled, pilot clinical trial, which will evaluate the efficacy, in terms of treatment tolerance, toxicity and response, body weight, body composition, protein-calorie intake, quality of life, fatigue, muscle strength and immunological profile of the early systematic provision of ONS enriched in immunonutrients compared to isonitrogenous and isocaloric standard blends, in H&N cancer patients undergoing CT-RT.
Consecutive adult (≥18 years) patients with a histologically confirmed diagnosis of H&N cancer and candidate to a platinum-based CT regimen and concomitant RT for adjuvant or curative purposes, will be considered eligible in presence of an Eastern Cooperative Oncology Group performance status ≤2.
Patients receiving nutritional counseling as standard of care will be randomized to consume 2 bottles per day of a high-calorie, high-protein ONS enriched (Impact® [237 mL per bottle]; Nestlé Health Science S.p.a, Italy) or not (Meritene Drink® [200 mL per bottle]; Nestlé Health Science S.p.a, Italy) in immunonutrients (arginine, nucleotides [RNA] and omega-3 fatty acids) for about 9 weeks - 2 weeks before up to the end of CT-RT or until withdrawal.
The present pilot study could represent one of the first proofs of the clinical effectiveness of early oral immunonutrition in cancer patients undergoing CT-RT and could stimulate further large, randomized trials, potentially resulting in the improvement of supportive care quality.
Trial design
This is a pragmatic, bicentric, randomized (1:1), parallel-group, open label, controlled, pilot clinical trial, which will evaluate the efficacy, in terms of treatment tolerance, toxicity and response, body weight, body composition, protein-calorie intake, quality of life, fatigue, muscle strength and immunological profile of the early systematic provision of ONS enriched in immunonutrients compared to isonitrogenous and isocaloric standard blends, in H&N cancer patients undergoing CT-RT.
Consecutive adult (≥18 years) patients with a histologically confirmed diagnosis of H&N cancer and candidate to a platinum-based CT regimen and concomitant RT for adjuvant or curative purposes, will be considered eligible in presence of an Eastern Cooperative Oncology Group performance status ≤2.
Patients receiving nutritional counseling as standard of care will be randomized to consume 2 bottles per day of a high-calorie, high-protein ONS enriched (Impact® [237 mL per bottle]; Nestlé Health Science S.p.a, Italy) or not (Meritene Drink® [200 mL per bottle]; Nestlé Health Science S.p.a, Italy) in immunonutrients (arginine, nucleotides [RNA] and omega-3 fatty acids) for about 9 weeks - 2 weeks before up to the end of CT-RT or until withdrawal.
The present pilot study, could represent one of the first proofs of the clinical effectiveness of early oral immunonutrition in cancer patients undergoing CT-RT and could stimulate further large randomized trials, potentially resulting in the improvement of supportive care quality.
Clinical trial identification
NCT04611113.
Editorial acknowledgement
Legal entity responsible for the study
R. Caccialanza.
Funding
Nestlè.
Disclosure
All authors have declared no conflicts of interest.