| CTRI Number |
CTRI/2024/08/072273 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study of side effects and quality of life in patients with oral cavity and oropharyngeal cancers undergoing radiotherapy. |
|
Scientific Title of Study
|
A study of oral mucositis, pain, xerostomia and quality of life in patients with oral cavity and oropharyngeal cancers undergoing radiotherapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TPAC.NO. 825 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr M Likhitha |
| Designation |
Junior resident (1st Year), M.D.Radiotherapy |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of Radiotherapy, Sri Venkateswara Institute of Medical Sciences, Alipiri road, Tirupati - 517507.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
8179509518 |
| Fax |
|
| Email |
likhithamangiri333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B V Subramanian |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences, Tirupati. |
| Address |
Department of Radiotherapy,
Sri Venkateswara Institute of Medical Sciences, Alipiri road,
Tirupati.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9849692950 |
| Fax |
|
| Email |
ravibalasubramanian@hotmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr B V Subramanian |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of Radiotherapy,
Sri Venkateswara Institute of Medical Sciences, Alipiri road,
Tirupati.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9849692950 |
| Fax |
|
| Email |
ravibalasubramanian@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences, Alipiri road,
Tirupati - 517507, Andhra Pradesh, India. |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences Tirupati |
| Address |
Sri Venkateswara Institute of Medical Sciences, Alipiri road, Tirupati.517507 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Likhitha |
Sri Venkateswara Institute of Medical Sciences |
Department of Radiotherapy, SVIMS cancer centre, Alipiri road, Tirupati, 517507.
Chittoor
ANDHRA PRADESH |
8179509518
likhithamangiri333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Venkateswara Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Carcinoma of head and neck including oral cavity, oropharynx undergoing IMRT, VMAT and concurrent chemotherapy .
2.Patients of age group between 18-65 yrs.
3.Patient with ECOG 0-2.
4.Patients willing to sign an informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with previous history of radiation to head and neck.
2. Patients with known distant metastasis.
3. Patients with ECOG 3-4
4. Pregnant women and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the toxicities in patients of head and neck cancer undergoing radiotherapy
1) pain,
2) oral mucositis
3) Xerostomia |
From Day 1 of treatment to 6 months after treatment completion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of life |
From Day 1 of treatment to 6 months after treatment completion. |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="67"
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)
|
16/08/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
Modification(s)
|
AIM AND OBJECTIVES AIM: To study the acute toxicities such as pain, mucositis and late sequelae of radiotherapy such as xerostomia in patients receiving concurrent chemo radiotherapy in Head and Neck cancer and also to assess quality of life in same patients. OBJECTIVES: PRIMARY OBJECTIVE: To assess the toxicities in patients of head and neck cancer undergoing radiotherapy (i pain, ii.oral mucositis, iii. Xerostomia.) SECONDARY OBJECTIVE: To assess the quality of life. SAMPLE SIZE: The calculated sample size is 67. INCLUSION AND EXCLUSION CRITERIA INCLUSION CRITERIA: · 1. Carcinoma of head and neck including oral cavity, oropharynx undergoing IMRT, VMAT and concurrent chemotherapy . · 2. Patients of age group between 18-65 yrs. · 3. Patient with ECOG 0-2. · 4. Patients willing to sign an informed consent. EXCLUSION CRITERIA: · 1. Patients with previous history of radiation to head and neck. · 2. Patients with known distant metastasis. · 3. Patients with ECOG 3-4 4. 4. Pregnant women and lactating mothers
PATIENT EVALUATION: All patients will be evaluated before RT ,weekly during the course of treatment and monthly for 3 months after radiotherapy for the acute toxicities(mucositis, pain, xerostomia, quality of life) and 6 months for late toxicities (xerostomia , quality of life). Assessment of pain will be done by using Visual Analogue Scale. Assessment of mucositis and xerostomia and grading will be done according to RTOG-Early and Late Radiation Morbidity scoring scheme. Assessment of Quality of life using EORTC QLQ H&N 35 Questionnaire. Follow up of the patients was advised monthly for 3 months and 2 monthly for 6 months. STATISTICAL ANALYSIS: Data will be collected in the study proforma , entered in Microsoft Excel(Windows 11;Version 2021)and analyses will be done using the Statistical Package for Social Sciences(SPSS)for Windows software (version 26.0;SPSS Inc, Chicago) .Continuous variables will be presented in the form of mean, standard deviation, range, and categorical data will be presented in the form of number and percentage. Chi-Square test or Fischers exact test will be used for qualitative parameters. Student’s t-test will be used for quantitative variables. P value <0.05 will be considered statistically significant |