| CTRI Number |
CTRI/2025/09/095468 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Physiotherapy along with Yoga] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of eclectic physiotherapeutic approach in patients receiving adjuvant therapy for cancer |
|
Scientific Title of Study
|
Effect of an eclectic physiotherapeutic approach on fatigue, hospital based anxiety and depression, AND quality of life in patients receiving adjuvant therapy for cancer: An experimental 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 Tushara Nair |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth deemed to be University |
| Address |
Jalaramnagar Society, Near M.M. Vora Showroom, Dabhoi Road, Vadodara
Vadodara
GUJARAT
390025
India |
| Phone |
9924744149 |
| Fax |
|
| Email |
tushara.nair2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushara Nair |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth deemed to be University |
| Address |
Jalaramnagar Society, Near M.M. Vora Showroom, Dabhoi Road, Vadodara
Vadodara
GUJARAT
390025
India |
| Phone |
9924744149 |
| Fax |
|
| Email |
tushara.nair2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tushara Nair |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth deemed to be University |
| Address |
Jalaramnagar Society, Near M.M. Vora Showroom, Dabhoi Road, Vadodara
Vadodara
GUJARAT
390025
India |
| Phone |
9924744149 |
| Fax |
|
| Email |
tushara.nair2@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Sumandeep Vidyapeeth deemed to be University, Piparia, Waghodia, Vadodara- 391760, Gujarat |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy, Sumandeep Vidyapeeth deemed to be University |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth deemed to be University, Piparia, Vadodara |
| Type of Sponsor |
Private medical college |
|
|
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 Tushara Nair |
Dhiraj General Hospital |
Oncology ward, Dhiraj General Hospital, College of Physiotherapy, Sumandeep Vidyapeeth deemed to be University, Piparia
Vadodara
GUJARAT |
9924744149
tushara.nair2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth 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, (2) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (3) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, (4) ICD-10 Condition: C40-C41||Malignant neoplasms of bone and articular cartilage, (5) ICD-10 Condition: C43-C44||Melanoma and other malignant neoplasms of skin, (6) ICD-10 Condition: C45-C49||Malignant neoplasms of mesothelial and soft tissue, (7) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (8) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (9) ICD-10 Condition: C60-C63||Malignant neoplasms of male genital organs, (10) ICD-10 Condition: C69-C72||Malignant neoplasms of eye, brain and other parts of central nervous system, (11) ICD-10 Condition: C73-C75||Malignant neoplasms of thyroid and other endocrine glands, (12) ICD-10 Condition: C7A-C7A||Malignant neuroendocrine tumors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eclectic Physiotherapeutic approach |
General mobility, strengthening, aerobics, Yoga, relaxation and recreational activities, Frequency- 5 times in an week for 4 weeks, 20 session- total |
| Comparator Agent |
Routine cancer care |
Includes routine care given at the hospital- Frequency- 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with cancer who have undergone surgery and are undergoing adjuvant therapy in the form of chemotherapy or radiotherapy with Eastern Cooperative Oncology Performance group score of less than 3 and single leg stance time of less than 5 seconds |
|
| ExclusionCriteria |
| Details |
Any hemodynamically unstable patient with diagnosed cardiac condition where exercises are contraindicated or any severe orthopaedic or neurological problems which can interfere with intervention or any recent surgery within 3 months other than that performed for cancer |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) sub scale, Hospital Anxiety and Depression Scale (HADS), RAND- 36 Questionnaire |
Baseline, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Daily Spiritual Experience Scale (DSES) |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
15/10/2025 |
| 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 aims to find the effect of an eclectic physiotherapeutic approach which is a multimodal approach which included many aspects of physiotherapy, Yoga and Recreational exercises for patients undergoing adjuvant chemotherapy or radiotherapy for cancer on the most common symptoms that is fatigue, anxiety and depression and quality of life. |