| CTRI Number |
CTRI/2025/10/096105 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Brain and nerve stimulation for depression in cancer patients receiving radiation. |
|
Scientific Title of Study
|
Comparing the effect of Transcranial direct current stimulation versus Transauricular vagus nerve stimulation on depressive symptoms in cancer patients undergoing radiation therapy- A Randomised Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayatri Govindankutty Marar |
| Designation |
Post graduate Student |
| Affiliation |
KLE Institute of Higher Education and Research Center |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Sagar Floor, Advanced physiotherapy center, Department of Neurology physiotherapy, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
07902341557 |
| Fax |
|
| Email |
gayatrimarar23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gayatri Govindankutty Marar |
| Designation |
PG Student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Sagar Floor, Advanced physiotherapy center, Department of Neurology physiotherapy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
07902341557 |
| Fax |
|
| Email |
gayatrimarar23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghavendrasingh Dharwadkar |
| Designation |
Assistant professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced physiotherapy center, Department of Neurophysiotherapy, Belgaum, Karnataka
B
Belgaum
KARNATAKA
590010
India |
| Phone |
07902341557 |
| Fax |
|
| Email |
raghavendrasingh@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar kore Hospital and Medical Research center, Department of neurology physiotherapy, Belgaum, Karnataka, India, 590010 |
|
|
Primary Sponsor
|
| Name |
Gayatri Govindankutty Marar |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced physiotherapy center, Department of Neurology physiotherapy, Belgaum, Karnataka, 590010 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Gayatri Govindankutty Marar |
KLEs Dr. Prabhakar kore Hospital and Medical Research center, Belagavi, Karnataka 590010 |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room no. 39, Sagar Floor, Advanced physiotherapy center, Department of Neurophysiotherapy, Belgaum, Karnataka
Belgaum
KARNATAKA |
07902341557
gayatrimarar23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
taVNS + Conventional physiotherapy |
Training frequency- 5 sessions per week Training duration- 30 minutes Number of weeks- 2 weeks Exercises- 30 minutes per session |
| Intervention |
tDCS + Conventional physiotherapy |
Training frequency- 5 sessions per week
Training duration- 30 minutes Number of weeks- 2 weeks Exercises- 30 minutes per session |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Participant diagnosed with cancer who are in the age group of 40 to 80 years of both genders.
2.Participants willing to participate.
3. Participants with beck depression inventory more than 13.
|
|
| ExclusionCriteria |
| Details |
1.Participants having any metal implants.
2.Participants who are undergoing any forms of psychotherapy.
3.Participants having history of uncontrolled epilepsy.
4.Participants having pacemaker.
5.Participants with acute ear infections.
6.Participants with cardiovascular risk or unstable cardiac disease.
7.Participants with unstable medical conditions.
8.Participants with active skin disease at electrode sites |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PHQ-9 scale is used to assess the depression and is assessed post intervention |
baseline and at 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| fatigue severity scale is used to assess fatigue level of the patient |
baseline & at 2 weeks |
| EORTC QOL-C30 scale is used to assess the quality of life |
baseline & at 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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 2 |
|
Date of First Enrollment (India)
|
30/10/2025 |
| 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
|
This study focuses on addressing the high prevalence of depression in cancer patients receiving radiotherapy, which negatively affects their quality of life, treatment adherence, and outcomes. Since pharmacological options may add side effects in patients already on multiple medications, this study explores two non-invasive neuromodulation techniques—tDCS and taVNS—as safer alternatives. Using a randomized clinical trial design with 22 participants, patients will be assigned to receive either tDCS or taVNS along with conventional physiotherapy for two weeks, and outcomes will be assessed using PHQ-9, Fatigue severity scale, and EORTC QLQ-C30 scales. The aim is to compare the effectiveness of tDCS and taVNS in reducing depressive symptoms, fatigue, and improving quality of life in this patient group. |