| CTRI Number |
CTRI/2025/11/097381 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Olanzapine for Cancer Anorexia-Cachexia in Carcinoma Cervix: A Prospective Study |
|
Scientific Title of Study
|
Olanzapine to improve cancer anorexia cachexia syndrome in patients with Cervix Carcinoma undergoing Radiotherapy with concurrent Cisplatin – a prospective randomised study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek Basu |
| Designation |
Associate Professor |
| Affiliation |
Burdwan Medical College and Hospital |
| Address |
Department of Radiation Oncology
Burdwan Medical College and Hospital
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9830303459 |
| Fax |
|
| Email |
drabhishekbasu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhishek Basu |
| Designation |
Associate Professor |
| Affiliation |
Burdwan Medical College and Hospital |
| Address |
Department of Radiation Oncology
Burdwan Medical College and Hospital
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9830303459 |
| Fax |
|
| Email |
drabhishekbasu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Basu |
| Designation |
Associate Professor |
| Affiliation |
Burdwan Medical College and Hospital |
| Address |
Department of Radiation Oncology
Burdwan Medical College and Hospital
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9830303459 |
| Fax |
|
| Email |
drabhishekbasu@yahoo.com |
|
|
Source of Monetary or Material Support
|
| BURDWAN MEDICAL COLLEGE AND HOSPITAL, Burdwan, Pincode 713104, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
ABHISHEK BASU |
| Address |
Department of Radiation Oncology,BURDWAN MEDICAL COLLEGE AND HOSPITAL, BURDWAN, PINCODE 713104, WEST BENGAL, INDIA |
| Type of Sponsor |
Other [Self] |
|
|
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 Abhishek Basu |
Burdwan Medical College and Hospital |
Department of Radiation Oncology, Burdwan Medical College and Hospital, Burdwan, West Bengal, Pin Code 713104, India
Barddhaman
WEST BENGAL |
9830303459
drabhishekbasu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE, BURDWAN MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Olanzapine |
Tab Olanzapine (2.5mg) will be given to intervention arm from start of treatment to the completion of treatment (8 weeks) to prevent Cancer Cachexia Anorexia Syndrome |
| Comparator Agent |
Placebo |
A placebo drug (starch) will be given to placebo arm once daily from start of treatment to end of treatment (8 weeks) to observe the effect on prevention of Cancer Cachexia Anorexia Syndrome |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Female |
| Details |
Patient should be treatment naive, Eastern Cooperative Oncology Group Perfomance Status scale (ECOG PS) should be between 0-2, FIGO STAGE (2021) 1-4, NO MAJOR LIFE THREATENING COMORBODITIES, BASELINE NORMAL BLOOD PARAMETERS |
|
| ExclusionCriteria |
| Details |
PATIENTS ON LONG TERM STEROIDS, Patients with PSYCHIATRIC ILLNESS, DENIAL OF CONSENT, PATIENTS WITH METABOLIC SYNDROME, PREGANCY AND LACTATION PATIENTS, BMI LESS THAN 18.5 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Weight and Appetite change in both the arms at the completion of treatment |
At the baseline, at 3rd week and at the end of 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess overal quality of life at the end of treatment in both the arms |
AT baseline, at 3rd week & at the end of 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/11/2025 |
| 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="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
|
Cancer Anorexia-Cachexia Syndrome is common in
cervical cancer and worsened by chemoradiation. Low-dose olanzapine is endorsed
in advanced cancer, but evidence during definitive chemoradiation is scarce. To
our knowledge, this is the first study to evaluate olanzapine in carcinoma
cervix
It is a Single-centre, prospective, randomized,
placebo-controlled trial in treatment-naïve cervical
cancer planned for radical radiotherapy with weekly cisplatin. Arm A will receive olanzapine 2.5 mg once daily for 12 weeks; Arm B will received placebo. Primary
outcomes: change in appetite (VAS, FAACT-ACS) and weight. Secondary: quality of
life (FAACT-G). Assessments at baseline, during treatment, and at 8 weeks;
ethics approval obtained. |