Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Cancer

NCT04001543 | Active Not Recruiting DMC

• 3 other identifiers: ICM-URC 2017/21GORTEC 2017-022018-A00518-47
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators designed a prospective randomized double-blind trial to determine if the oral immunomodulating formula could improve the disease-free survival rate in high-risk locally-advanced head and neck Squamous Cell Carcinoma patients treated with Chemoradiotherapy.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

head and neck squamous cell carcinoma (HNSCC); immunomodulatory nutrient; concomitant chemoradiotherapy; survival

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS)

  2-years DFS rate

  From date of randomization until the date of the first documented progression (local, regional, metastatic) or date of death from any cause, whichever came first, assessed up to 2 years.

Secondary Outcomes (6)

• Overall Survival (OS)

  From date of randomization until the date of death from any cause, assessed up to 3 years.

• Rate of drug compliance

  up to 45 days

• Adverse events rate

  until 3 months after radiotherapy

• Quality of life by using the general quality of life questionnaire about cancer (QLQ-C30).

  Quality of life will be assessed up to 2 years after the last day of radiotherapy.

• Quality of life by using the specific quality of life questionnaire about head and neck cancer (HN35)

  Quality of life will be assessed up to 2 years after the last day of radiotherapy.

Study Arms (2)

Immunomodulating oral supplementation

EXPERIMENTAL

The immunomodulating oral supplementation compound (Oral Impact®) contains 334kcal/bag and 18.1g of proteins, as well as immunomodulatory nutrients such as L-Arginine, RNA and omega-3. Each bag of product containing powder (74g/bag) will be diluted in 250 millilitres of water by the patients and drunk at home. Three doses will be drunk at home by the patients daily, during the 5 days before each chemotherapy cycle.

Dietary Supplement: Immunomodulating oral supplementation

Sip feed control

ACTIVE COMPARATOR

The control has the same formula to that of the Oral Impact®, but not enriched with specific nutrients: it is an isocaloric isonitrogenous control. Each bag of product containing powder (74g/bag) will be diluted in 250 millilitres of water by the patients and drunk at home. Three doses will be drunk at home by the patients daily, during the 5 days before each chemotherapy cycle.

Dietary Supplement: Sip feed control

Interventions

Immunomodulating oral supplementation DIETARY_SUPPLEMENT

Per os administration, 3 times / day, 5 days before each cycle of chemotherapy.

Immunomodulating oral supplementation

Sip feed control DIETARY_SUPPLEMENT

Per os administration, 3 times / day, 5 days before each cycle of chemotherapy.

Sip feed control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgically resected primary squamous cell carcinomas (HNSCC) of the hypopharynx, oropharynx, larynx and oral cavity with pathological stage pT1-2 pN+ (pathological stage 1 ou 2 with node) or pT3-4 any pN (pathological stage 3 ou 4 with or without node) (UICC 7th edition, 2010),
• Postoperative concomitant CRT based on radiotherapy and on cisplatinum, 3 cycles, 100mg/m² by cycle,
• Patients who undergone macroscopically complete resection,
• High-risk characteristics patients with one or more following criteria: such as invasion of two or more regional lymph nodes, extracapsular extension of nodal disease or microscopically-involved mucosal margins of resection, perineural involvement, vascular tumor embolism,
• WHO (World Health Organization) performance status 0, 1 or 2,
• Age: 18 years old up to 75 years old including,

You may not qualify if:

• Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers
• Sepsis at baseline
• Distant metastasis
• Parenteral nutrition at baseline
• History of hypersensitivity and/or allergy to any component of Oral Impact ®
• Patients with history of malignancies who are not disease-free for more than 5 years.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (2)

Centre Léon Bérard

Lyon, 69373, France

Location

Institut du Cancer de Montpellier

Montpellier, 34298, France

Location

Related Publications (5)

• Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44. doi: 10.1056/NEJMoa032646.

  PMID: 15128893 BACKGROUND

• Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefebvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52. doi: 10.1056/NEJMoa032641.

  PMID: 15128894 BACKGROUND

• Machon C, Thezenas S, Dupuy AM, Assenat E, Michel F, Mas E, Senesse P, Cristol JP. Immunonutrition before and during radiochemotherapy: improvement of inflammatory parameters in head and neck cancer patients. Support Care Cancer. 2012 Dec;20(12):3129-35. doi: 10.1007/s00520-012-1444-5. Epub 2012 Mar 28.

  PMID: 22453793 BACKGROUND

• Vasson MP, Talvas J, Perche O, Dillies AF, Bachmann P, Pezet D, Achim AC, Pommier P, Racadot S, Weber A, Ramdani M, Kwiatkowski F, Bouteloup C. Immunonutrition improves functional capacities in head and neck and esophageal cancer patients undergoing radiochemotherapy: a randomized clinical trial. Clin Nutr. 2014 Apr;33(2):204-10. doi: 10.1016/j.clnu.2013.06.008. Epub 2013 Jun 20.

  PMID: 23849811 BACKGROUND

• De Geest S, Sabate E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323. doi: 10.1016/S1474-5151(03)00091-4. No abstract available.

  PMID: 14667488 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Pierre SENESSE, MD

  Institut du Cancer de Montpellier - Val d'Aurelle

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 28, 2019
• Study Start: March 14, 2019
• Primary Completion: March 2, 2021
• Study Completion: May 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)