Immunonutrition and Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Efficacy of Immunonutrition in Improving Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04611113
• Other study ID #: 20200060578
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: May 2022
• Source: IRCCS Policlinico S. Matteo
• Contact: Riccardo Caccialanza, MD
• Phone: 0382501615
• Email: r.caccialanza[@]smatteo.pv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of head-neck cancer

• indication to curative or adjuvant chemoradiotherapy

• availability to planned measurements and to written informed consent.

Exclusion Criteria:

• age <18 years

• indication to or ongoing artificial nutrition

• refusal

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Dietary Supplement:
• Immunonutrition
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.
• Control Nutritional Support
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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Boisselier P, Kaminsky MC, Thézenas S, Gallocher O, Lavau-Denes S, Garcia-Ramirez M, Alfonsi M, Cupissol D, de Forges H, Janiszewski C, Geoffrois L, Sire C, Senesse P; Head and Neck Oncology and Radiotherapy Group (GORTEC). A double-blind phase III trial of immunomodulating nutritional formula during adjuvant chemoradiotherapy in head and neck cancer patients: IMPATOX. Am J Clin Nutr. 2020 Dec 10;112(6):1523-1531. doi: 10.1093/ajcn/nqaa227. — View Citation

Cereda E, Cappello S, Colombo S, Klersy C, Imarisio I, Turri A, Caraccia M, Borioli V, Monaco T, Benazzo M, Pedrazzoli P, Corbella F, Caccialanza R. Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy. Radiother Oncol. 2018 Jan;126(1):81-88. doi: 10.1016/j.radonc.2017.10.015. Epub 2017 Oct 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum levels of immunologic markers	Change in levels of soluble effectors and immuno-regulatory cells during the study	9 weeks
Primary	Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]	Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0	9 weeks
Secondary	Total chemotherapy dose	To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan	9 weeks
Secondary	Total radiotherapy dose	To be calculated as the percentage of radiotherapy dose administered with respect to the treatment plan	9 weeks
Secondary	Duration of treatment	To be calculated as the percentage of variation of the duration of the chemotherapy and radiotherapy compared to the planned duration	9 weeks
Secondary	Toxicity-free survival	Difference in the time to onset of moderate-severe adverse events as assessed by CTCAE v5.0	9 weeks
Secondary	Adherence to treatment schedule	Difference in the proportion of patients completing the treatment schedule as planned	9 weeks
Secondary	Treatment-related adverse events as assessed by CTCAE v5.0	Difference in the incidence of any toxicity, according to Common Terminology Criteria for Adverse Events [CTCAE v5.0]	9 weeks
Secondary	Objective response rate	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	9 weeks
Secondary	Body weight	Change in body weight during the study	9 weeks
Secondary	Energy intake	Change in energy intake during the study	9 weeks
Secondary	Handgrip strength	Change in handgrip strength during the study	9 weeks
Secondary	Skeletal muscle mass	Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans (C3)	9 weeks
Secondary	Self-perceived quality of life	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]	9 weeks
Secondary	Fatigue	Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire	9 weeks
Secondary	Patients requiring unplanned hospitalization	The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated	9 weeks