| CTRI Number |
CTRI/2022/06/043364 [Registered on: 20/06/2022] Trial Registered Prospectively |
| Last Modified On: |
17/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of salivary gland function before and after salivary gland sparing radiotherapy in head-neck cancers. |
|
Scientific Title of Study
|
Evaluation of submandibular salivary gland function using quantitative pertechnetate scintigraphy and estimation of dose–response relationship of submandibular gland sparing radiotherapy in head-neck cancers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shyama Prem S |
| Designation |
Professor |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Department of Radiation oncology, Regional Cancer Center, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9787814215 |
| Fax |
|
| Email |
shyamaprems1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasoon Garg |
| Designation |
Junior resident |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Department of radiation oncology, Regional Cancer Center, Building number 7, JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9566431356 |
| Fax |
|
| Email |
98.prasoon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prasoon Garg |
| Designation |
Junior resident |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Department of radiation oncology, Regional Cancer Center, Building number 7, JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9566431356 |
| Fax |
|
| Email |
98.prasoon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund from JIPMER |
|
|
Primary Sponsor
|
| Name |
Jawaharlal institute of Postgraduate Medical Education and Research |
| Address |
JIPMER, Gorimedu, Pondicherry, 605006 |
| 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 |
| Shyama Prem S |
Regional Cancer Center, Jawaharlal Institute of Postgraduate Medical Education and Research |
Building number 7, Department of radiation oncology, Regional Cancer Center, JIPMER, Gorimedu, Pondicherry, 605006
Pondicherry
PONDICHERRY |
9787814215
shyamaprems1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Comparator Agent |
Only parotid sparing volumetric modulated arc therapy
|
Patients with head and neck cancer receiving only parotid sparing volumetric modulated arc therapy
|
| Intervention |
Submandibular gland plus parotid sparing volumetric modulated arc therapy. |
Patients with head and neck cancer receiving submandibular gland plus parotid sparing volumetric modulated arc therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients over 18 years of age
2. Patients with ECOG performance status 0 - 2
3. Patients of squamous cell carcinoma of the head and neck planned for radical radiation with or without concurrent chemotherapy treated with volumetric modulated arc radiotherapy
|
|
| ExclusionCriteria |
| Details |
1. Patients with previous history of radiotherapy to head and neck
2. Patients with carcinoma of the head and neck in whom the submandibular glands are enclosed completely in the clinical target volume.
3. Tumour involvement of both the submandibular glands
4. Pre–existing salivary gland disease
5. Previous or concurrent illness that would compromise completion of treatment or follow-up
6. Patient receiving prophylactic amifostine or pilocarpine
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the difference in the maximum salivary uptake (U max) between patients whose submandibular glands were spared compared to those in whom they were not spared at 6 months post-radiation. |
To assess the difference in the maximum salivary uptake (U max) between patients whose submandibular glands were spared compared to those in whom they were not spared at 6 months post-radiation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the maximum salivary uptake (U max) for the normal submandibular glands pre- radiation |
Pre-radiation |
| To assess the difference in the maximum salivary uptake (U max) between patients whose submandibular glands were spared compared to those in whom they were not spared |
3months and 1 year post-radiation |
| To assess the relative change in the excretion rate (ΔF) between patients whose submandibular glands were spared compared to those in whom they were not spared |
3months, 6 months and 1 year post radiation |
To assess the correlation between Umax and the mean submandibular doses
|
3 months, 6 months and 1 year post radiation |
| To assess the correlation between Umax and patient reported outcomes measured using xerostomia questionnaire (XQ) |
3 months, 6 months and 1 year post radiation |
| To assess the correlation between the Umax and unstimulated and stimulated salivary flow rate measured by sialometry. |
3 months, 6 months and 1 year post radiation |
To assess the correlation between relative change in the excretion rate and the mean submandibular doses.
|
3 months, 6 months and 1 year post radiation |
| To assess the correlation between relative change in the excretion rate and patient reported outcomes measured using xerostomia questionnaire (XQ) |
3 months, 6 months and 1 year post radiation |
To assess the correlation between the relative change in the excretion rate and unstimulated and stimulated salivary flow rate measured by sialometry.
|
3 months, 6 months and 1 year post radiation |
| To assess the excretion rate for the normal submandibular glands pre- radiation. |
Pre-radiation |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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 |
|
Date of First Enrollment (India)
|
22/06/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
We will publish the results of the study in International journals so that this information can be
spread to oncologists worldwide. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
One of the main treatments for cancers of the head and neck is radiotherapy. Dry mouth is a frequent complication of radiation to the head and neck region. Reducing the amount of radiation to the salivary glands is necessary to reduce dry mouth. Normally the largest salivary gland called the parotids is not allowed to receive a high dose of radiation during planning of radiation to reduce the frequency of dry mouth. The submandibular glands located under the jaw produce most of the saliva at rest and during sleep. As it frequently lies close to the tumour, the amount of radiation going to the submandibular gland cannot usually be restricted. However, depending on the tumour position, it is possible to reduce the amount of radiation to the submandibular glands without compromising on tumour dose. Currently, there are very few studies that have found out how different doses of radiation to the submandibular gland alter its functions. The purpose of this study is to evaluate the function of the salivary glands before and after radiation using a method called salivary scintigraphy. |