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Completed

NCT Number: NCT05101889

Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation

This study evaluated the benefits of immunonutrition regarding the prevention of severe mucositis. Patients with head and neck cancer (HNC) undergoing definitive concurrent chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase II study. Patients were randomly assigned to receive an immunonutrition containing omega-3-fatty acids, arginine, dietary nucleotides, and soluble fiber or an isocaloric isonitrogenous control. All patients received the assigned product 5 days before each chemotherapy session. The proportion of patients with severe mucositis was compared between the immunonutrition and control groups.

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Key information

Conditions

Oral Mucositis Head and Neck Neoplasms Mouth Diseases Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatitis Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age of 18-65 years
  • histological confirmation of stage II-IVb non-metastatic HNC according to the seventh edition of the American Joint Committee on Cancer Staging System (AJCC 2010)
  • receipt of definitive CCRT
  • Eastern Cooperative Oncology Group performance status of 0-1
  • creatinine clearance ≥ 60 mL/min/1.73 m2 calculated by the Cockcroft-Gault formula
  • absence of mucositis
  • able to tolerate oral feeding

Exclusion criteria

  • receipt of curative surgery for HNC
  • allergies to any component of the immunonutrition

Treatment and study plan

Oral Impact®

Dietary Supplement

3 ready-to-drink bottles/day

Other names: Blendera®

Primary outcomes

  1. Severe oral mucositis graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 criteria

    Time frame: 6 weeks after initiation of concurrent chemoradiation (CCRT)

    Proportion of severe oral mucositis between two groups

Secondary outcomes

  1. Other treatment-related toxicities graded according to the NCI CTCAE version 4.03 criteria

    Time frame: through study completion, an average of 6 weeks

    Proportion of patients with other treatment-related toxicities between two groups

  2. body weight in kilograms

    Time frame: 6 weeks after initiation of CCRT and 1 month after CCRT completion

    mean changes of body weight between two groups

  3. serum albumin in grams per deciliter (g/dL)

    Time frame: 6 weeks after initiation of CCRT and 1 month after CCRT completion

    mean serum albumin between two groups

  4. hemoglobin in grams per deciliter (g/dL)

    Time frame: 6 weeks after initiation of CCRT and 1 month after CCRT completion

    mean hemoglobin between two groups

  5. C-reactive protein (CRP) in milligrams per liter (mg/L)

    Time frame: 6 weeks after initiation of CCRT and 1 month after CCRT completion

    mean CRP between two groups

  6. neutrophil-to-lymphocyte ratio (NLR)

    Time frame: 6 weeks after initiation of CCRT and 1 month after CCRT completion

    mean NLR between two groups

  7. platelet-to-lymphocyte ratio (PLR)

    Time frame: 6 weeks after initiation of CCRT and 1 month after CCRT completion

    mean PLR between two groups

  8. actual dose of radiation in centigrays (cGy)

    Time frame: through study completion, an average of 6 weeks

    mean actual dose of radiation between two groups

  9. cumulative dose of cisplatin in milligrams per square meter (mg/m2)

    Time frame: through study completion, an average of 6 weeks

    mean cumulative dose of cisplatin between two groups

  10. progression-free survival (PFS)

    Time frame: at 3 years

    compare PFS between two groups

  11. overall survival (OS)

    Time frame: at 3 years

    compare OS between two groups

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation: A Phase II Randomized, Double-blind Study

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2021
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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