| CTRI Number |
CTRI/2020/06/026165 [Registered on: 26/06/2020] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial for prevention of radiotherapy induced dry mouth in patients with oropharyngeal cancer |
|
Scientific Title of Study
|
Prevention of Radiotherapy Induced Xerostomia by Intraductal Administration of N-Acetyl Cysteine
in Patients with Oropharyngeal Malignancies: A Randomized Clinical Trial |
| Trial Acronym |
NAC-RIX |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arvind Kumar Kairo |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Rno 4057, Teaching Block, Department of Otorhinolaryngology,
All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9868491991 |
| Fax |
|
| Email |
arvindkairo@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Kumar Kairo |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Rno 4057, Teaching Block, Department of Otorhinolaryngology,
All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9868491991 |
| Fax |
|
| Email |
arvindkairo@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Kumar Kairo |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Rno 4057, Teaching Block, Department of Otorhinolaryngology,
All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9868491991 |
| Fax |
|
| Email |
arvindkairo@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Arvind Kumar Kairo |
| Address |
Department of Otorhinolaryngology, AIIMS, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ahitagni Biswas |
Department of Radioptherapy, AIIMS |
| Dr Alok Thakkar |
Department of ENT, AIIMS |
| Dr Pooja Gupta |
Department of Pharmacology, AIIMS |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arvind Kumar Kairo |
AIIMS, New Delhi |
Departments of ENT, Radiotherapy, Pharmacology
New Delhi
DELHI |
9868491991
arvindkairo@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
N-acetyl cysteine (NAC) |
3-5 ml of 2% NAC will be given as bilateral instillation in the duct of submandibular salivary gland before each radiotherapy fraction for 6-7 weeks |
| Comparator Agent |
Normal saline |
3-5 ml normal saline will be given as bilateral instillation in the duct of submandibular salivary gland before each radiotherapy fraction for 6-7 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of oropharyngeal carcinoma
2. Either gender with age between 18-70 years (both inclusive)
3. Planned for radical external beam radiotherapy |
|
| ExclusionCriteria |
| Details |
1. Patients with decreased mouth opening
2. A coexisting disease causing xerostomia
3. Revision cases
4. Denial for consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in severity grading of xerostomia according to RTOG EORTC scoring system |
2 weeks, 3 months, 6 months and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quantity (in ml) of stimulated saliva |
2 weeks, 3 months, 6 months and 1 year |
| pH and viscosity of and IgA levels in saliva |
2 weeks, 3 months, 6 months and 1 year |
| Change in quality of life |
2 weeks, 3 months, 6 months and 1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/07/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Oropharyangeal cancer constitutes a substantial proportion of head and neck cancers and is prevalent worldwide including India. Radiotherapy-induced xerostomia (RIX) occurs in around 70 percent of the cases undergoing radiation therapy. The symptoms affect the quality of life of the patients considerably and no therapy has been proven reasonably effective to prevent or treat the complication. The complications arise due to proximity of the salivary glands to the target affected tissue. Evidence suggests that such damage occurs due to free radicals generated by radiotherapy which on one hand kills the tumor tissues while also collaterally damaging the salivary glands. This study will use a well-established antioxidant which is considered safe i.e. N-Acetyl cysteine (NAC). It has free radical scavenging property to prevent the free radical induced injury to salivary glands. The local use of NAC will likely prevent this collateral damage in disease free glands. If the results are gained as expected, the therapy would stand to be safe, effective and cheap as a preventive measure against RIX. |