| CTRI Number |
CTRI/2018/02/012237 [Registered on: 28/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the relationship between the nutritional status of cancer patients and cancer related tiredness. |
|
Scientific Title of Study
|
Nutritional profile of Cancer Patients; an observational study at a Tertiary Care Hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praveena Gayathri |
| Designation |
Consultant- Pain management and Palliative Department |
| Affiliation |
Narayana Hrudayalaya Hospital |
| Address |
Mazumdar Shaw Medical Center, Narayana Hrudayalaya Pvt Ltd
No. 258/A Bommasandra Industrial Area, Hosur road
Bangalore
KARNATAKA
560099
India |
| Phone |
9379005556 |
| Fax |
|
| Email |
praveenakarnam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sagar S Bhat |
| Designation |
Dentist |
| Affiliation |
The Oxford Dental College |
| Address |
#699, Sri Neelambike, 66th cross, first stage, Kumaraswamy layout, Hosur road, Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
9900475056 |
| Fax |
|
| Email |
sagarbhat1994@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar S Bhat |
| Designation |
Dentist |
| Affiliation |
The Oxford Dental College |
| Address |
#699, Sri Neelambike, 66th cross, first stage, Kumaraswamy layout, Hosur road, Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
9900475056 |
| Fax |
|
| Email |
sagarbhat1994@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Mazumdar Shaw Medical Centre, Narayana Hrudayalaya Hospital, No. 258/A, Bommasandra Industrial Area, Hosur road, Bengaluru, Karnataka- 560099 |
|
|
Primary Sponsor
|
| Name |
Mazumdar Shaw Medical Center Narayana Hrudayalaya Hospital |
| Address |
No. 258/A Bommasandra Industrial Area, Hosur Road, Bangalore- 560099, Karnataka, 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 |
| Dr Praveena Gayathri |
Mazumdar Shaw Medical Center |
Research Department,first floor, Narayana Hrudayalaya Pvt Ltd, No.258/A, Bommasandra Industrial Area, Hosur Road
Bangalore
KARNATAKA |
9739005556
praveenakarnam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All consenting consecutive patients with a physician diagnosis of any cancer over the age of 18 years being treated in outpatient care or admitted in day care for short stay. |
|
| ExclusionCriteria |
| Details |
a)Patients in have a performance status of Eastern Cooperative Oncology Group 4 as assessed by the physician
b)Patients with an implantable cardiac device – pacemakers, Implantable cardioverter defibrillators or any device known to be affected by a Bioelectric Impedance analyzer.
c)Previously participated in this study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the nutritional status in cancer patients using Karada scanner |
baseline (day 0) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate cancer related fatigue using FACT-G Version 4 questionnaire |
Baseline(Day 0) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2015 |
| Date of Study Completion (India) |
16/12/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Drafting manuscript for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cancer is a
chronic disease condition that can affect the body metabolism and nutrition.
Certain cancers affect muscle mass, body fat and reduce the energy levels
leading to cachexia, sarcopenia and fatigue. This study is to assess the nutritional status of cancer patients
using a
bioelectric impedance analyzer (HBF-352, Omron Health care Co., Kyoto, Japan)
and to study its correlation with a Cancer Related Fatigue Score.
People with a diagnosis of cancer, seen in the out patient
department or admitted at Day Care for short procedures or treatment will be
invited to participate. After getting consent the subject’s nutritional status
will be assessed. The Karada Scanner is a simple instrument that is used
to measures the patients’ anthropometry through bioelectric
impedance. We will administer a Standardized 12 point scale questionnaire to
assess the Cancer Related Fatigue. |