Immune-enhancing Diet Before and After Surgery for better recovery for Patients with Head and Neck Cancers

Effect of Perioperative Immune-Enhancing Diet in Head & Neck Cancer Surgery - A Randomized Control Trial - IEDiet-HN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060411

Enrollment

272

Registered

2023-12-01

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Immune Enhancing Diet: IED consists of glutamine, omega 3 (fish oil) and arginine Control Intervention1: Standard Diet: The standard diet will be as per the current dietary practice fol

Eligibility

Inclusion criteria

Inclusion criteria: 1. Treatment naive Patients with Oral Squamous cell carcinoma (OSCC) planned for radical surgery 2. Age = 18 and = 75 3. Patients with American Society of Anesthesiologists (ASA) grades I, II, or III 4. No history of diabetes or if diabetic, HBA1c = 7.5. 5. Liver function tests (ALT, AST, ALP, and bilirubin) within normal limits 6. The baseline BMI should be between 18 to 25. 7. Preoperative albumin level = 3.0

Exclusion criteria

Exclusion criteria: 1. Patients with ASA grade > III 2. Pregnancy 3. Nutritionally challenged patients requiring supplementation pre surgery as decided by the treating physician and dietician. 4. Non-SCC cases 5. Patients undergoing free flap reconstruction. 6. Patients who are undergoing re-exploration 7. Patients undergoing re-surgery for recurrence. 8. Patients who have undergone any prior alternate treatments or post NACT. 9. Patients with metastases. 10. Patients with renal insufficiency were serum creatinine > 2mg/dl. 11. Patients not willing for Omega-3 from fish oil.

Design outcomes

Primary

Measure	Time frame
Primary Outcome: The primary outcome expected from the study is early recovery of serum albumin levels in immune enhanced diet arm than control arm. We will measure the Proportion of patients who will achieve normal Serum albumin levels on day 14 after Surgery in both the groups (Standard diet vs Immune enhancing diet) and compare statistically. Secondary Outcome: Secondary outcome of the study is early wound healing in immune enhanced diet arm than control arm. Timepoint: Following are the time points to check serum albumin and anthropometric measurements: a. Baseline for recruitment into the study (7–10 days prior to the date of Surgery) S-albumin, Body weight, and anthropometric measurements b. Day 1 post-operation (serum albumin and CRP) c. Day 2 post-surgery (Body weight) d. Day 7 post-surgery (Body weight, S albumin, CRP) e. Day 14 post-surgery. (Body weight, S albumin, CRP anthropometric measurements)	—

Measure

Time frame

Primary Outcome: The primary outcome expected from the study is early recovery of serum albumin levels in immune enhanced diet arm than control arm. We will measure the Proportion of patients who will achieve normal Serum albumin levels on day 14 after Surgery in both the groups (Standard diet vs Immune enhancing diet) and compare statistically. Secondary Outcome: Secondary outcome of the study is early wound healing in immune enhanced diet arm than control arm. Timepoint: Following are the time points to check serum albumin and anthropometric measurements: a. Baseline for recruitment into the study (7–10 days prior to the date of Surgery) S-albumin, Body weight, and anthropometric measurements b. Day 1 post-operation (serum albumin and CRP) c. Day 2 post-surgery (Body weight) d. Day 7 post-surgery (Body weight, S albumin, CRP) e. Day 14 post-surgery. (Body weight, S albumin, CRP anthropometric measurements)

—

Secondary

Measure	Time frame
To find the effect of immune enhancing diet on inflammatory marker – serum CRP (C Reactive Protein) Timepoint: To study & correlate effect of immune enhancing diet on length of hospital stay To study effect of supplementation of immune enhanced nutrients on Wound healing.	—

Countries

India

Contacts

Public ContactDr Sudhir V Nair

Tata Memorial Centre

sudhirvr@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026