| CTRI Number |
CTRI/2025/02/080973 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Acceptance of Feeding Tube in Head and Neck Cancer Patients |
|
Scientific Title of Study
|
Factors affecting Nasogastric tube acceptance in newly diagnosed Head and Neck cancer patients– Single Institutional experience |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujatha Lakshminarayanan |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (WIA), Adyar |
| Address |
Cancer Institute (WIA), 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036
Chennai TAMIL NADU 600036 India |
| Phone |
9500037675 |
| Fax |
|
| Email |
drsujatha@ymail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sujatha Lakshminarayanan |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (WIA), Adyar |
| Address |
Cancer Institute (WIA), 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036
TAMIL NADU 600036 India |
| Phone |
9500037675 |
| Fax |
|
| Email |
drsujatha@ymail.com |
|
Details of Contact Person Public Query
|
| Name |
Sujatha Lakshminarayanan |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (WIA), Adyar |
| Address |
Cancer Institute (WIA), 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036
TAMIL NADU 600036 India |
| Phone |
9500037675 |
| Fax |
|
| Email |
drsujatha@ymail.com |
|
|
Source of Monetary or Material Support
|
| Cancer Institute (WIA), 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036 |
|
|
Primary Sponsor
|
| Name |
Cancer Institute (WIA) |
| Address |
38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sujatha Lakshminarayanan |
Cancer Institute (WIA), Adyar |
Department of Medical Gastroenterology, Dr V Shantha Wing, 4th floor, Bhagwan Adinath Diagnostic complex, Dr S Krishnamoorthi Campus, 38 Sardar Patel Road, adjacent to I.I.T. Madras, Chennai 600036 Chennai TAMIL NADU |
9500037675
drsujatha@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Cancer Institute (WIA), Regional cancer centre, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18years to 80 years
2. All newly detected head and neck cancer patients with difficulty in eating
3. Patients who are willing to give consent for the study
|
|
| ExclusionCriteria |
| Details |
1. Patients who is not willing to give consent for the study
2. Patients with contraindications for nasogastric tube placement
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the acceptance of NGT feeding in patients with newly diagnosed head and neck cancers |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the factors that influence NGT acceptance in newly diagnosed head & neck cancers |
baseline |
|
|
Target Sample Size
|
Total Sample Size="715" Sample Size from India="715"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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="1" 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
|
Head and neck cancers are increasingly prevalent,
particularly in developing countries, driven largely by tobacco use and HPV
infection. Oral cancers are the most common subtype in Southeast Asia. These
cancers and their treatments significantly impair chewing and swallowing, often
leading to malnutrition, weight loss, and fatigue, which can hinder treatment
effectiveness and worsen patient outcomes. Nasogastric tubes (NGTs) are
frequently required for nutritional support in these patients, but their acceptance
is often challenged by psychosocial factors. Many patients resist NGT insertion
due to concerns about discomfort, appearance, and perceived bodily violation.
This study investigates the factors influencing NGT acceptance in newly
diagnosed head and neck cancer patients. The research will explore the
correlation between NGT acceptance and factors like age, disease stage,
dysphagia severity, and various psychosocial aspects. Statistical analysis,
including linear and logistic regression, t-tests/ANOVA, and Pearson’s
correlation, will be employed to identify significant relationships. The study
anticipates that patients with more advanced disease or severe dysphagia will
be more likely to accept NGTs. Furthermore, it aims to identify specific
psychosocial factors impacting acceptance, such as body image concerns,
perceived loss of independence, and cultural beliefs surrounding illness and
medical interventions. A common misconception among patients is that NGTs are
only necessary in advanced stages of emaciation, hindering early intervention.
By understanding the factors influencing NGT acceptance, this study aims to
develop targeted strategies to improve acceptance rates and optimize
nutritional support, ultimately enhancing the care and outcomes for head and
neck cancer patients. |