| CTRI Number |
CTRI/2024/04/065805 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/04/2024 |
| 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
|
Is Cognitive Rehabilitation Effective in Improving Cognition and Quality of Life of Patients with Chemotherapy-Related Cognitive Issues |
|
Scientific Title of Study
|
Effectiveness of Cognitive Rehabilitation on Cognition and Quality of Life in Chemotherapy-Induced Cognitive Impairment- A Randomized Control 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 |
Dr Gayatri Kaple |
| Designation |
Junior Resident |
| Affiliation |
Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research |
| Address |
Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research (Deemed to be University) Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9765421582 |
| Fax |
|
| Email |
gkaple9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Moh’d Irshad Qureshi |
| Designation |
Professor Neurophysiotherapy Department |
| Affiliation |
Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research |
| Address |
Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research (Deemed to be University) Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9406010010 |
| Fax |
|
| Email |
irshadphysio@rediffamail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Moh’d Irshad Qureshi |
| Designation |
Professor Neuro-Physiotherapy Department |
| Affiliation |
Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research |
| Address |
Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research (Deemed to be University) Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9406010010 |
| Fax |
|
| Email |
irshadphysio@rediffamail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi Meghe, Wardha-442001, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Department of Neuro Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi (Meghe), Wardha-442004. |
| 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 |
| Dr Gayatri Kaple |
Siddharth Gupta Memorial Cancer Hospital, Cancer Ward and Cancer OPD |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi Meghe, Wardha-442001, Maharashtra, India
Wardha
MAHARASHTRA |
9765421582
gkaple9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aerobic exercises and Cognitive Behavioral Therapy |
Subjects will receive aerobic exercises and Cognitive Behavioural Training per day. It includes brisk walking, cycling, jogging, and solving a cognitive skill workbook for 45 min per day weekly till the last cycle of chemotherapy, which is not done under supervision. The Duration of the Study will be 4 weeks. |
| Intervention |
Aerobic Exercises and Cognitive rehabilitation |
After identifying the cognitive impairment, cognitive rehabilitation and aerobic exercises will be given for the duration of 45 minutes when there will be for mild- moderate cognitive impairment according to mini- mental state examination (MMSE), which will include internal cognitive training (ICT), including mnemonics, chunking, methods of loci, story recall and list/object recall. In mnemonics, participants are asked to recognize the photo and remember the name of that person by self-generating mnemonics; chunking is a process of taking individual pieces of information (chunks) and grouping them into large units; the method of memory enhancement uses visualizations with the use of spatial memory; story recall is when reading or listening to a story; it might be helpful to focus on only the key points of the story, this way irrelevant information can be forgotten and the story may simplify and be easier to recall and in last recall the list of things or list of items needed for cooking or shopping, etc. It combines chunking and the method of loci.
The external cognitive training (ECT) included cueing, spaced retrieval, face-name recall, and number recall. Cueing by providing relevant cues at recall can aid retrieval and can be useful when teaching information, particularly face-name recall or number recall. Two types of cueing are vanishing cues (cueing with decreasing assistance) or forward cues (cueing with increasing assistance); spaced retrieval helps to aid increase retention of information. This strategy is beneficial for face-name associations, object naming, memory of object location, face-name recall, and presenting a photograph of the to-be-remembered person. Discuss the photograph and name. Generate mnemonics (or association) that can be used to assist recall. It combines with cueing and spaced retrieval, number recall, and presents the to-be-remembered numbers in verbal and written formats. Discuss the number, what it is for, how often it is used, etc., and generate mnemonics (or associations) that can be used to assist recall. It also combines with cueing and spaced retrieval.
The Duration of study will be 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Newly diagnosed patients with stages I to III cancers planning to receive a definitive number of platinum-based compounds chemotherapy.
2) Patients who are given Taxanes and Platinum-based compounds – Cisplastin, Carboplatin and Oxaliplatin
3) 3) Patients having Grade I or II cognitive impairment according to National Cancer Institute –common toxicity criteria.
4) Planned to receive a minimum of 4 cycles of chemotherapy treatment with either of the chemotherapy agents (Platinum based compound)
5) Both Male and female aged grouped between 14-70 years.
6) Patients who are given drugs according to approval of national cancer board
|
|
| ExclusionCriteria |
| Details |
1) Patients having Pre-existing cognitive impairment.
2) Patient having Traumatic Brain Injury.
3) Patients having a previous history of any psychological condition that could impair cognitive function.
4) Patients who did not perceive any chemotherapy cycle after cancer treatment.
5) Patients with a previous history of cancer and chemotherapeutic drugs.
6) Those who were having any neurological disorders in the brain and spinal cord such as Alzheimer’s disease (AD), Lewy body disease, stroke (CVA), Huntington’s disease, MS, ALS, frontotemporal dementia, and vascular dementia; use of medication known to have a negative impact on cognition (benzodiazepines).
7) Use of antipsychotics and cholinesterase inhibitors (CHEIs); current or recent (past 6 months) alcohol or substance use disorder; any behavioural changes like depression, anxiety, stress, other systemic diseases likely to impair cognition, such as hypothyroidism, deï¬ciency of folic acid or vitamin B12, or viral infection (syphilis, HIV); vision and speech impairment (aphasia).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mini Mental State Examination
2. Montreal Cognitive Assessment
3. Functional Assessment of Cancer Therapy Cognitive |
Baseline data will be collected and data analysis will be done after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
2. Patient Specific Functional Scale |
Baseline data will be collected and data analysis will be done after 4 weeks |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
12/05/2024 |
| 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
|
The study aims to evaluate the effect of cognitive rehabilitation on cognition and quality of life in chemotherapy-induced cognitive impairment in cancer patients. |