| CTRI Number |
CTRI/2016/02/006677 [Registered on: 25/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
24/02/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effects of chemotherapy on neurobehaviour of cancer patients:an observational study |
|
Scientific Title of Study
|
Effects of chemotherapy on cognition in cancer patients: an observational study. |
| Trial Acronym |
chemofog |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dinesh Bhurani |
| Designation |
Cheif of Haemato-Oncology Services & Senior Bone Marrow Transplant Specialist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
206, Rajiv Gandhi Cancer Institute and Research Centre, Sector-5, Rohini West, New Delhi
West
DELHI
110085
India |
| Phone |
09971500861 |
| Fax |
|
| Email |
bhurani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Research Lab,Centre For Translational Science & Clinical Research, Faculty of Science
Jamia Hamdard, New Delhi-110062
South
DELHI
110062
India |
| Phone |
09818334770 |
| Fax |
|
| Email |
nidhi.bharal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohd Ashif Khan |
| Designation |
PhD Research Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Research Lab,Centre For Translational Science & Clinical Research, Faculty of Science
Jamia Hamdard, New Delhi-110062
South
DELHI
110062
India |
| Phone |
8285861595 |
| Fax |
|
| Email |
mhdashifkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Centre For Translational and Clinical Trial,
Jamia Hamdard New Delhi-110062 |
| 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 Dinesh Bhurani |
Rajiv Gandhi Cancer Institute & Research Centre |
sector-5, Rohini West, New Delhi
South
DELHI |
09971500861
bhurani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajiv Gandhi cancer Institute and Research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients diagnosed with cancer undergoing chemotherapy were enrolled, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient must have histologically and cytologically confirmed cancer.
2.Patient receiving chemotherapy for the treatment of cancer.
3.Both males and female patients.
4.Patient capable of giving informed consent
5.Patient willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.History of cognitive impairment and Alzheimer’s disease.
2.History of head injury
3.Patients had evidence of uncontrolled clinical diseases, including diabetes, rheumatologic diseases, asthamatic diseases or other chronic inflammatory conditions.
4.Patient having brain cancer.
5.Patient having neuropsychiatric disorders.
6.On any psychotropic medications.
7.History of schizophrenia and other neurological and neurobehavioural diseases.
8.Habit of any substance of abuse.
9.Using any concurrent medication like Donepezil, rivastigmine, galantamine, Memantine Tacrine cholinergic drugs.
10.Patient using anti inflammatory drugs.
11.Alcoholics.
12.Incompetent for interview. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assesment of neurobehaviour in cancer patients by validated questionnaire |
1 day before 1st, 2nd and 3rd and 4th cycle of chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assesment of socioeconomic status of patient using questionnire |
NA |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
22/08/2014 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients undergoing chemotherapy for various kinds of cancer were assessed for cognitive assessment at three cycles of chemotherapy using MMSE score. Discarded blood samples were collected after each cycle for inflammation assessment using ELISA. Its an observational study to find out the correlation between cognition and inflammation by chemotherapy |