| CTRI Number |
CTRI/2025/02/081229 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Vocal Cord mobility recovery in previously fixed cords in laryngopharyngeal cancer after chemoradiation in 118 patients: A Hospital Based study |
|
Scientific Title of Study
|
Assessment of Vocal Cord Mobility in Laryngopharyngeal Cancers with Fixed Vocal Cord After Definitive Chemoradiation A Prospective Hospital Based Observational Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apurba Kumar Kalita |
| Designation |
Professor, Head Of Department |
| Affiliation |
Dr Bhubaneswar Borooah Cancer Institute |
| Address |
Department of Radiation Oncology, Dr Bhubaneswar Borooah Cancer Institute , AK Azad Road, Gopinath Nagar Rd, Bishnu Rabha Nagar, Guwahati, Assam 781016
Kamrup
ASSAM
781005
India |
| Phone |
9864035015 |
| Fax |
9864035015 |
| Email |
apurbakumar.kalita@bbci.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama Das |
| Designation |
Post Graduate Trainee |
| Affiliation |
Dr Bhubaneswar Borooah Cancer Institute |
| Address |
Department of Radiation Oncology, Dr Bhubaneswar Borooah Cancer Institute , AK Azad Road, Gopinath Nagar Rd, Bishnu Rabha Nagar, Guwahati, Assam 781016
Kamrup
ASSAM
781005
India |
| Phone |
8729994867 |
| Fax |
|
| Email |
anupamadas56@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupama Das |
| Designation |
Post Graduate Trainee |
| Affiliation |
Dr Bhubaneswar Borooah Cancer Institute |
| Address |
Department of Radiation Oncology, Dr Bhubaneswar Borooah Cancer Institute , AK Azad Road, Gopinath Nagar Rd, Bishnu Rabha Nagar, Guwahati, Assam 781016
Kamrup
ASSAM
781005
India |
| Phone |
|
| Fax |
|
| Email |
anupamadas56@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Bhubaneswar Borooah Cancer Institute |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Anupama Das |
Dr Bhubaneswar Borooah Cancer Institute |
Department of Radiation Oncology, Dr Bhubaneswar Borooah Cancer Institute , AK Azad Road, Gopinath Nagar Rd, Bishnu Rabha Nagar, Guwahati, Assam 781016
Kamrup
ASSAM |
8729994867
anupamadas56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDICAL ETHICS COMMITTEE, BBCI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C13||Malignant neoplasm of hypopharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NUL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Histologically proven laryngopharyngeal cancers with unilateral or bilateral fixed vocal cords confirmed with endoscopy or laryngoscopy, patients giving written informed consent to participate in the study,patients with ECOG PS 0 to 2,baseline CBC, LFT and RFT are within normal limits, at least 3 months of follow up after completion of treatment
|
|
| ExclusionCriteria |
| Details |
Patients with vocal cord mobility impairment due to causes other than laryngopharyngeal cancers and its treatment (eg: congenital anomalies, trauma, neurological disorders), patients with laryngopharyngeal cancers with extra laryngeal extension or cartilage erosion,patient unwilling or unable to participate in follow-up assessments,patients with other concurrent head and neck cancers,patients with uncontrolled cardiovascular, pulmonary or metabolic renal disease,patient with metastatic laryngopharyngeal cancers with fixed vocal cords.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| RESTORATION OF VOCAL CORD MOBILITY AFTER DEFINITIVE CHEMO RADIATION IN LARYNGOPHARYNGEAL CANCERS WITH PREVIOUSLY FIXED VOCAL CORDS ASSESSED USING DIRECT LARYNGOSCOPY OR ENDOSCOPY AT SPECIFIC TIME INTERVALS. COMPLETE ABDUCTION OF VOCAL CORDS DEFINED AS SEPARATION OF ATLEAST 1 CM FROM MIDLINE WILL BE CONSIDERED AS INDICATOR RESTORED MOBILITY. |
At 6 weeks post definitive chemoradiation and at 3 months post definitive chemoradiation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess for acute radiotherapy induced toxicities,to assess the voice related quality of life using Voice Handicap Index (VHI) in these group of patients.
|
Acute Radiotherapy Induced toxicities will be assessed during treatment weekly.
Voice Related Quality of life will be evaluated using Voice Handicap Index pre treatment, at 6 weeks post treatment and at 3 months post treatment |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
06/03/2025 |
| 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 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
|
This study is a prospective, hospital-based observational research project conducted at Dr. Bhubaneswar. Borooah Cancer Institute, Guwahati, over a duration of one year. Its primary aim is to evaluate the restoration of vocal cord mobility in patients with laryngopharyngeal cancers presenting with fixed vocal cords following definitive chemoradiation. The study also focuses on assessing treatment-induced toxicities and the impact on patients’ voice-related quality of life using the Voice Handicap Index (VHI). The research adopts a non-randomized, non-interventional design with a planned sample size of 118 patients. Eligible participants are aged between 18–70 years, have histologically proven laryngopharyngeal cancer with vocal cord fixity confirmed through laryngoscopy or endoscopy, and meet specific health and consent criteria. The treatment protocol includes standard chemoradiation comprising a total radiation dose of 66–70 Gy alongside weekly cisplatin chemotherapy. Patients undergo thorough pre-treatment evaluation and weekly monitoring during the treatment period to minimize interruptions and assess radiation-induced toxicities. Post-treatment assessments are conducted at 6 weeks and 3 months, using laryngoscopy or endoscopy to measure vocal cord mobility restoration. Restoration is defined as complete vocal cord abduction, with at least 1 cm separation from the midline. In addition to its primary goal, the study evaluates radiotherapy toxicities based on CTCAE criteria and assesses changes in patients’ voice quality using VHI questionnaires. The findings will contribute to understanding the functional outcomes of organ preservation approaches and the prognostic significance of vocal cord mobility post-chemoradiation. The results are expected to provide insights for improving treatment protocols and patient quality of life. |