A Clinical Trial to study the effects of two nutritional supplements, protein supplement and immuno-nutritional supplement in the patients with Oral squamous cell carcinoma.

Comparative Evaluation of the Peri-operative Efficacy of Immuno-nutritional and Protein Supplements as a Dietary Adjunct in Participants Undergoing Surgical Management of Oral Squamous Cell Carcinoma-A Prospective Randomized Double Blind Study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/11/029442

Enrollment

Registered

2020-11-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: Immunomax Nutritional supplement: 600 mg once a day for 1 week preoperatively and 3 weeks postoperatively by oral route. Control Intervention1: Protein nutritional supplement: 600 mg on

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants of both the genders in the age group of 18-70 years. 2. Participants with Oral Squamous Cell Carcinoma who will undergo surgical resection of the tumor. 3. Participants with Oral Squamous Cell Carcinoma who will undergo surgical resection of the tumor with chemotherapy and/or Radiotherapy. 4. Participants in whom the planned surgery will be performed for duration of 4-6 hours. 5. Participants willing for study.

Exclusion criteria

Exclusion criteria: 1. Participants who have upper arm deformities. 2. Participants who are declared inoperable and are planned for palliative cancer therapies like radiotherapy and chemotherapy. 3. Participants in whom upper limb skin/flap is used for reconstruction purpose. 4. Participants who are a recurrence case of oral squamous cell carcinoma. 5. Participants who have undergone previous major surgeries under GA. 6. Participants presently suffering from a condition other than oral squamous cell carcinoma that also requires surgical intervention. 7. Participants who have a Renal Disorders and risen levels of Serum Creatinine. 8. Participants who have uncontrolled Diabetes. 9. Participants in whom the surgery will be undertaken for more than 6 hours. 10. Participants with Severe Sepsis. 11. ICU patients with severe illness who do not tolerate more than 700ml enteral feed per day.

Design outcomes

Secondary

Measure	Time frame
1) To assess and compare the post-operative wound healing in the participants undergoing surgical management of Oral Squamous Cell Carcinoma who are given immuno-nutritional and protein supplements as a dietary adjunct at 3rd and 4th week post-operatvely. 2) To assess and compare the length of post-operative hospital stay in participants undergoing surgical management of Oral Squamous Cell Carcinoma who are given immuno-nutritional and protein supplements as a dietary adjunct.Timepoint: 3rd and 4th week post-operatively	—

Measure

Time frame

1) To assess and compare the post-operative wound healing in the participants undergoing surgical management of Oral Squamous Cell Carcinoma who are given immuno-nutritional and protein supplements as a dietary adjunct at 3rd and 4th week post-operatvely. 2) To assess and compare the length of post-operative hospital stay in participants undergoing surgical management of Oral Squamous Cell Carcinoma who are given immuno-nutritional and protein supplements as a dietary adjunct.Timepoint: 3rd and 4th week post-operatively

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Primary

Measure	Time frame
To assess and compare peri-operative Body Mass Index (BMI), Mid Arm Muscle Circumference(MAMC), Triceps Skin Fold (TSF) and parameters described under Subjective Global Assessment (SGA) form of participants undergoing surgical management of Oral Squamous Cell Carcinoma who are given immuno-nutritional and protein supplements as a dietary adjunct at 1 week pre-operatively and at the end of 3rd and 4th week post-operatively.Timepoint: 3rd and 4th week post-operatively	—

Measure

Time frame

To assess and compare peri-operative Body Mass Index (BMI), Mid Arm Muscle Circumference(MAMC), Triceps Skin Fold (TSF) and parameters described under Subjective Global Assessment (SGA) form of participants undergoing surgical management of Oral Squamous Cell Carcinoma who are given immuno-nutritional and protein supplements as a dietary adjunct at 1 week pre-operatively and at the end of 3rd and 4th week post-operatively.Timepoint: 3rd and 4th week post-operatively

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Countries

India

Contacts

Public ContactDr Srivalli Natarajan

MGM Dental college and hospital

drsagar.vaishampayan@gmail.com9769917711

Outcome results

None listed

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