| CTRI Number |
CTRI/2024/08/072096 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of nutrition therapy in oral cancer patients
|
|
Scientific Title of Study
|
Role of nutritional therapy in oral squamous cell carcinoma patients in improving nutritional indices- a prospective study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| YEC-1/2024/042, version 4, 17/05/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajah Shaikh |
| Designation |
post graduate student |
| Affiliation |
yenepoya dental college |
| Address |
Room no 4, department of oral and maxillofacial surgery, yenepoya dental college, university road, deralakatte
Dakshina Kannada
KARNATAKA
571850
India |
| Phone |
7038011029 |
| Fax |
|
| Email |
rajahfatima.1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Hari Kishore Bhat |
| Designation |
Associate professor |
| Affiliation |
yenepoya dental college |
| Address |
Room no 4, department of oral and maxillofacial surgery, yenepoya dental college, university road, deralakatte
Dakshina Kannada
KARNATAKA
571850
India |
| Phone |
8496962992 |
| Fax |
|
| Email |
Harikishore@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rajah Shaikh |
| Designation |
post graduate student |
| Affiliation |
yenepoya dental college |
| Address |
Room no 4, department of oral and maxillofacial surgery, yenepoya dental college, university road, deralakatte
Dakshina Kannada
KARNATAKA
571850
India |
| Phone |
7038011029 |
| Fax |
|
| Email |
rajahfatima.1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya dental college, Yenepoya (deemed to be) University, university road, deralakatte, Mangalore- 575018, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Rajah Shaikh |
| Address |
plot no 23, mehboob nagar, aurangabad, Maharashtra, India. 431001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajah Shaikh |
Zulekha Yenepoya Institue of Oncology |
Room no 4, department of oral and maxillofacial surgery, yenepoya dental college, university road, deralakatte
Dakshina Kannada
KARNATAKA |
7038011029
rajahfatima.1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nutritional intervention |
nutritional chart and nutritional counselling provided following oral cancer treatment, for a period of 1 year. Monthly telephonic consultation with the participants to check progress, followed by participant visit to the hospital for consultation 6 months and 1 year post treatment |
| Comparator Agent |
Regular nutritional pattern followed by patient prior to treatment and counselling |
The study compares the effectiveness of providing a nutritional protocol to participants undergoing treatment for oral cancer. The changes in the blood albumin level and the overall quality of life will be assessed before and after providing a nutrition protocol |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients newly diagnosed with primary oral squamous cell carcinoma
Patients with operable Oral Squamous Cell Carcinoma in any subsite
|
|
| ExclusionCriteria |
| Details |
Patients with previous history of having undergone oral squamous cell carcinoma treatment
Patients with recurrent oral cancer
Patients with systemic comorbidities.
Patients with oral submucous fibrosis stage 2,3,4 (Haider et al classification)
Patients with proven distant metastasis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measuring the improvement in nutritional indices and overall health via questionnaires and nutritional indices |
At diagnosis, immediately after intervention, at 6 months post intervention, nd 1 yr post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in quality of life |
1 year |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cancer-related malnutrition is an often overlooked and undertreated
symptom in cancer-affected patients despite approximately 10-20% of deaths
occurring from malnutrition in cancer suffering patients. Various body
measurements have been used to diagnose malnutrition and concomitant
sarcopenia. Nutritional indices have been shown to have prognostic value in
various types of cancer. in this study, we want to assess the of nutritional indices in patients
suffering from oral squamous cell carcinoma and the role of nutritional therapy
following treatment. We will achieve this by performing a preoperative nutritional
assessment using questionnaires (Scored Patient-Generated Subjective Global
Assessment (PG-SGA)), anthropometric measurements and nutritional indices (PNI,
NRI, SII) (calculated using serum albumin, peripheral blood samples, and the
previously measured anthropometric data), we will also check for serum albumin
and C-reactive protein levels pre-treatment. Post treatment, participants will
be provided with a nutritional regimen and appropriate oral nutritional
supplements (ONS). There will be two follow-ups, at 3 months and 6 months,
where the assessments will be done in a similar manner as preoperatively. Additionally,
clinical interview will be conducted and additional questionnaires (the head
and neck symptom checklist and EORTC QLQ C30) will be administered to assess
quality of life. The results will provide us with insight on the role of
nutritional therapy in improving prognostic nutritional indices post oral
squamous cell carcinoma treatment. The study will take place over a course of 2
and half years, with the participants being chosen from among the patients
reporting to the Zulekha Yenepoya Institute of Oncology by simple random
sampling. |