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Completed

NCT Number: NCT06318221

Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer

A prospective randomized controlled study compared the effects of perioperative immunonutrition and standard enteral nutrition (EN) on postoperative short-term outcomes of patients with head and neck (HNC).

Five days before surgery and the postoperative day 10, immunonutrition support was given to the intervention group (n=17), and standard EN support was given to the control group (n=17). Body analyses were made, food consumption records were taken, NRS-2002 and quality of life scales were applied, and biochemical parameters were recorded.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Nutrition, Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Talas, Kayseri, 38280, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Clinical diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx who will undergo surgery,
  • who agree to receive standard EN or immunonutrition before surgery,
  • those between the ages of 18-75,
  • those with normal hematopoietic (absolute neutrophil count >1.8x109/L, hemoglobin level ≥9 g/dL) hepatic and renal function

Exclusion criteria

  • Patients receiving neoadjuvant chemotherapy or radiotherapy to the head and neck region;
  • Received EN support before the study
  • have an active infection, any autoimmune, renal or hepatic disease, malabsorption, type 1 diabetes or mental illness
  • taking vitamin-mineral supplements and immunosuppressive treatment,
  • Morbidly obese (BMI ≥40 kg/m2), HIV positive, pregnant and breastfeeding individuals

Treatment and study plan

Experimental (Immunonutrition) Group

Dietary Supplement

Immunonutrition was given to the patients in the intervention group and ready-to-use liquid in addition to their normal nutrition 5 days before the operation. The patients were instructed to consume three enteral products per day as taken between meals.

In the postoperative period, feeding was started in the first 24 hours with the NG tube placed during the operation. The ready-to-use immunonutrition product was given to the patients in the intervention group.

Active Comparator Group ( Standard enteral nutrition)

Dietary Supplement

Standard enteral nutrition was given to patients in the control group in addition to their normal nutrition 5 days before the operation. The patients were instructed to consume three enteral products per day between meals.

In the postoperative period, feeding was started in the first 24 hours with the NG tube placed during the operation. Liquid standard enteral nutrition was given to the patients in the control group.

Primary outcomes

  1. Body weight

    Time frame: 40 days

    Kg

  2. Body weight loss

    Time frame: 40 days

    Kg

  3. Body mass index

    Time frame: 40 days

    kg/m2

  4. Resting metabolic rate

    Time frame: 40 days

    kcal

  5. Nutrition Risk Screening 2002

    Time frame: 40 days

    A total score of ≥3 indicates that the patient is at nutritional risk

  6. The EORTC Core Quality of Life questionnaire-30 (EORTC QLQ-C30)

    Time frame: 40 days

    • Estimate the average of the items that contribute to the scale; this is the raw score.
    • Use a linear transformation to standardise the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

  7. The EORTC Quality of life - Head and Neck Cancer Module (EORTC QLQ-H & N35)

    Time frame: 40 days

    The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning).

  8. Albumin

    Time frame: 40 days

    g/dL

  9. C-reactive protein

    Time frame: 40 days

    mg/L

  10. Prealbumin

    Time frame: 40 days

    mg/dL

Secondary outcomes

  1. Length of hospital stay

    Time frame: 40 days

    days

  2. Complication development status

    Time frame: 40 days

    It was evaluated as yes/no.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

A Randomized Clinical Trial With Perioperative Immunonutrition Support on Anthropometric, Clinical and Biochemical Parameters of Head and Neck Cancer Patients Undergoing Surgery

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2024
Registry last updated
Mar 19, 2024

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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