| CTRI Number |
CTRI/2015/11/006392 [Registered on: 30/11/2015] Trial Registered Prospectively |
| Last Modified On: |
14/06/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Study to find the distress, expectations, preferences and QOL in patients treated with palliative chemotherapy in Head and neck cancers |
|
Scientific Title of Study
|
A prospective observational study to assess the expectations, preferences, distress and QOL in patients undergoing palliative chemotherapy in Head and neck cancers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 183 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Patil |
| Designation |
Asst professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
11th Floor Homi Bhabha Block Tata Memorial Hospital, Dr E Borges Road, Parel
11th Floor Homi Bhabha Block Tata Memorial Hospital, Dr E Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224176314 |
| Fax |
|
| Email |
vijaypgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Patil |
| Designation |
Asst professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
11th Floor Homi Bhabha Block Tata Memorial Hospital, Dr E Borges Road, Parel
11th Floor Homi Bhabha Block Tata Memorial Hospital, Dr E Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224176314 |
| Fax |
|
| Email |
vijaypgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Patil |
| Designation |
Asst professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
11th Floor Homi Bhabha Block Tata Memorial Hospital, Dr E Borges Road, Parel
11th Floor Homi Bhabha Block Tata Memorial Hospital, Dr E Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224176314 |
| Fax |
|
| Email |
vijaypgi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Dr E Borges Road, Parel, Mumbai |
| 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 Vijay Patil |
Tata MemorialHospital |
Room no 204
HBB 2nd Floor Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
02224176314
vijaypgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Name of Committee Approval Status Date of Approval Approval Document Is IEC? Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients must have histologically confirmed squamous cell cancers of the Head and neck region warranting palliative chemotherapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants must have histologically confirmed squamous cell cancers of the Head and neck region warranting palliative chemotherapy
2. Age : Any age above 18 years. No maximum age.
3. ECOG performance status ≤2
4. Life expectancy of less than 12 months with standard palliative treatments.
5. Participants must have normal organ and marrow function as defined below:
a. Leukocytes ≥3,000/mcL
b. Platelets ≥100,000/mcL
c. Total bilirubin < 1.5 times normal
d. AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
e. Calculated Creatinine clearance > 30 ml/min
6. Both men and women of all races and ethnic groups are eligible for this trial
7. Ability to understand Hindi, Marathi or English language
8. Ability to understand and the willingness to sign a written informed consent document.
|
|
| ExclusionCriteria |
| Details |
1. Uncontrolled intercurrent illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis) or psychiatric illness/social situations that would limit compliance with study requirements. Patients should be considered physiologically fit to withstand major cancer surgery.
2. Pregnant women and breastfeeding women are excluded from this study
3. HIV-positive, Hepatitis B and C seropositive patients are excluded from this study.
4. Patients with previous history of other cancers.
5. Patients who have been started on palliative chemotherapy regimen. ( Patients who have received previous palliative chemotherapy and awaiting start of second line chemotherapy are not excluded)
ECOG PS 0-2
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The percentage of patients opting for increase in survival as the primary expectation from chemotherapy |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The preferences for chemotherapy
2. Identify patients having high distress scores ( score 4 or more) and factors associated with it
1. Factors studied would be age (above or below 70 years), sex( Male/Female), socioeconomic status ( Above poverty line/ Below poverty line) and residential address ( Mumbai / Rest of Maharashtra / Rest of India).
3. To asses proportion of patients having improvement in QOL at 2 months with palliative chemotherapy
|
1.Day 1
2.Time point : Day 1
3.2 month
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
30/11/2015 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective observational single arm study in 200 patients, newly started on palliative chemotherapy in Head and neck cancers. These patients would be administered three short questionnaires; NCCN distress thermometer, Chemotherapy expectations and preference questionnaire and FACT H&N questionnaire at baseline. The first 2 proformas would be filled by the interviewer while the 3rd proforma (FACT) will be self administered by the patient. These patients would receive there palliative chemotherapy according to institutional guidelines. Then again at 2 monthly intervals for 6 months FACT H&N questionnaire would be administered. The primary expectation of patients for chemotherapy, their preferences for it , the baseline distress levels, the compliance for the 3 questionnaires and the improvement in QOL at 2 months would be studied. |