| CTRI Number |
CTRI/2024/11/076214 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Trial to check the effectiveness of olanzapine drug in prevention weight loss in locally advanced head and neck cancer patients planned for chemoradiation |
|
Scientific Title of Study
|
Low-dose Olanzapine vs. Placebo in Preventing Weight Loss
during Radiation for Patients with Locally Advanced HNSCC:
A Double Blinded RCT |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Sethi |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of Radiation Oncology
RCC, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9543601257 |
| Fax |
|
| Email |
docpujasethi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pooja Sethi |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of Radiation Oncology
RCC, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9543601257 |
| Fax |
|
| Email |
docpujasethi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Sethi |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of Radiation Oncology
RCC, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9543601257 |
| Fax |
|
| Email |
docpujasethi@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER, Puducherry, India (Pincode-605006) |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006. |
| 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 Pooja Sethi |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Block No-8
Department of Radiation Oncology
Regional Cancer Centre
Pondicherry
PONDICHERRY |
9543601257
docpujasethi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Institute of Postgraduate Medical Education and Research-Institutional Ethics Committee Interventional Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low Dose Olanzapine |
Oral Tablet -Olanzapine 2.5 mg
OD for 12-16 weeks |
| Comparator Agent |
Placebo |
Oral Tablet- Matching Placebo (containing starch) for 12-16 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 - 65 years at the time of enrolment
2. Male and Female
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
4. LA-HNSCC – Stage III, IVA, IVB planned for radical radiation (with or without concurrent
chemotherapy)
5. Patients taking oral/enteral diet at least in liquid or semisolid form
6. Patients with Adequate organ function at time of participation, defined as
Hematological: Hemoglobin more than 9gm/dl, TLC more than 4000 mm3, ANC more than 1500/mm3
,Platelet more than 100000/mm3, Liver Function test: Bilirubin less than 2 x upper limit normal (ULN), AST/ALT/ ALP less than 2.5 x ULN, PTless than 1.5 X ULN or International Normalized Ratio less than 1. 5, Renal Function test: Creatinine less than 1.5 X ULN, Creatinine, Clearance more than 60 ml/mins, Magnesium more than lower limit of normal |
|
| ExclusionCriteria |
| Details |
1. Earlier chemotherapy / radiotherapy
2. Intake of olanzapine in last 2 monthsfor any other
indications
3. On any antipsychotic or antidepressants
4. Use of systemic corticosteroids (prednisolone
5mg or equivalent for more than 7 days in the previous 4 weeks)
5. Pregnancy
6. Any other synchronous malignancy or uncontrolled viral/bacterial infection (such as tuberculosis, hepatitis B or Hepatitis C infection)
7. Planned for adjuvant chemoradiation, Neoadjuvant chemotherapy,Psychiatric problem that required immediate attention, including acute suicidality;
8. A current diagnosis of substance abuse or dependence, schizophrenia, schizophreniform disorder, or bipolar illness
9. Neurological problem, including movement disorder (e.g., tardive dyskinesia), history of a seizure disorder, or dementia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight loss more than 5% from baseline |
Within one week after treatment completion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
mean change in body weight from baseline
|
within one week of treatment completion |
change in symptoms of anorexia as assessed by VAS and
FAACT-ACS |
within one week of treatment completion |
| change in quality of life (QOL) as assessed by CI-QOL-Q |
within one week of treatment completion |
| change in nutrition & calorie intake |
within one week of treatment completion |
change in body
composition parameters such as LBM, FFMI,
FMI as assessed by BIA |
within one week of treatment completion |
| toxicity profile (highest grade) during chemoradiation |
within one week of treatment completion |
Time to develop more than 2 grade toxicities during
chemoradiation |
within one week of treatment completion |
| drug side effect/ adverse event profile |
within one week of treatment completion |
Treatment response as assessed by RECIST
criteria |
At 2 months of treatment completion |
| Event free survival & Overall survival |
At 6 months of treatment completion |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Purpose of the study is To compare the effect of olanzapine at a dose of 2.5 mg once a day for 12-16 weeks added to standard dietary advice in reducing the proportion who develop weight loss >5% from the baseline in patients planned for radiation (with or without concurrent chemotherapy) for Head and Neck Squamous cell carcinoma |