| CTRI Number |
CTRI/2025/10/096360 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| 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
|
A study to see if gentle electrical stimulation machine on the head and daily time-based exercises can help reduce tiredness, anxiety, and depression in women with breast cancer who are getting chemotherapy. |
|
Scientific Title of Study
|
Transcranial Direct Current Stimulation(tDCS) and Circadian Rhythm Time-Based Conventional Exercises for Fatigue, Anxiety and Depression in Breast Cancer patients undergoing chemotherapy:A Single-Blind Randomized Controlled 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 |
Simran Kaur Ram Prakash Singh Rahanu |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, Room no.39, opd no.19, Neurology Physiotherapy Department, KLES Dr.Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Karnataka 590010 Belgaum India.
Belgaum
KARNATAKA
590010
India |
| Phone |
08850471245 |
| Fax |
|
| Email |
rahanusimrankaur99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjiv Kumar |
| Designation |
MPT, PHD,FIAP Professor Department of Neurology Physiotherapy. |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre,Room no.39, opd no.19,Neurology Physiotherapy Department, KLES Dr.Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Karnataka 590010 Belgaum India.
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjiv Kumar |
| Designation |
MPT, PHD,FIAP Professor Department of Neurology Physiotherapy. |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre,Room no.39, opd no.19,Neurology Physiotherapy Department, KLES Dr.Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Karnataka 590010 Belgaum India.
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi- 590010 |
|
|
Primary Sponsor
|
| Name |
Simran Kaur Ram Prakash Singh Rahanu |
| Address |
Advanced Physiotherapy Centre,Room no.39, opd no.19,Neurology Physiotherapy Department, KLES Dr.Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Karnataka 590010 Belgaum India. |
| 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 |
| Simran Kaur Ram Prakash Singh Rahanu |
KLES Dr.Prabhakar Kore Hospital and Medical Research Centre |
Advanced Physiotherapy Centre,Room no.39, opd no.19,Neurology Physiotherapy Department, KLES Dr.Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi, Karnataka 590010 Belgaum India.
Belgaum
KARNATAKA |
8850471245
rahanusimrankaur99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
sham tDCS with circadian rhythm time -based exercises |
Participants will receive sham tDCS for 4 weeks 5 sessions per week with identical electrode placement and parameters; the current will be ramped up for 30 seconds and then turned off to mimic sensations of stimulation.The exercise program combines daily aerobic walking and resistance band training to reduce fatigue and maintain strength. Exercises are performed 7 days/week for 4 weeks at moderate intensity (60–70% HRR). The walking goal is to increase daily steps by 5–20% each week toward 10,000 steps/day. Resistance training includes 11 upper-body movements (e.g., curls, presses, rows), beginning with 1 set × 8–15 repetitions and progressing up to 4 sets.The intervention time was specifically set between 8:30 and 9:30 a.m |
| Intervention |
tDCS with circadian rhythm time-based exercises |
Participants will receive active tDCS over the dorsolateral prefrontal cortex (DLPFC) at 2 mA for 20 minutes per session, 5 sessions per week for 4 weeks, using saline-soaked sponge electrodes (anode over left DLPFC [F3], cathode over right supraorbital region [Fp2]). The exercise program combines daily aerobic walking and resistance band training to reduce fatigue and maintain strength. Exercises are performed 7 days/week for 4 weeks at moderate intensity (60–70% HRR). The walking goal is to increase daily steps by 5–20% each week toward 10,000 steps/day. Resistance training includes 11 upper-body movements (e.g., curls, presses, rows), beginning with 1 set × 8–15 repetitions and progressing up to 4 sets. The routine is monitored and adjusted weekly.The intervention time was specifically set between 8:30 and 9:30 a.m |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
diagnosed with stage I–III breast cancer, scheduled to receive adjuvant or neoadjuvant chemotherapy, received approval from a medical oncologist to participate in the trial |
|
| ExclusionCriteria |
| Details |
traumatic brain injury or concussion with residual
symptoms, mobility issues that require a mobility aid or an injury/illness that would prohibit exercising, self-reported physical or cognitive condition that prevented women from participating independently |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
FACIT-Fatigue scale
|
total 4 weeks of protocol,outcome will be assessed at baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Beck Anxiety Inventory
|
which will be assessed at baseline and after 4 weeks |
| Beck Depression Inventory |
which will be assessed at baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| Date of Study Completion (India) |
19/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 involves breast cancer patients screened by inclusion and exclusion criteria. After obtaining written informed consent and demographic data, participants are randomly allocated by the envelope method into two groups—Group A receives active transcranial direct current stimulation (tDCS) combined with circadian rhythm time-based conventional exercises, while Group B receives sham tDCS with circadian rhythm time-based conventional exercises.
Pre-intervention and post-intervention assessments are conducted using fatigue anxiety and depression outcome measures. the FACIT-Fatigue scale the Beck Anxiety Inventory (BAI) and Beck Depression Inventory . Both tDCS and the exercise interventions are administered by trained physiotherapists. The study aims to evaluate the efficacy of combining tDCS targeting fatigue with exercise timed to circadian rhythms on fatigue, anxiety and depression in breast cancer patients undergoing chemotherapy.
The intervention time was specifically set between 8:30 and 9:30 a.m., based on recommendations from the International Commission on Illumination and the WELL Building Standard, which suggest that adequate circadian stimulation in the morning.
This design allows controlled observation of the added effect of active tDCS over sham stimulation on fatigue anxiety and depression outcomes alongside standard exercise therapy, providing evidence for integrative rehabilitation approaches.
|