| CTRI Number |
CTRI/2024/03/064371 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of nutritional advise and olanzapine on weight gain among children with cancer |
|
Scientific Title of Study
|
Olanzapine for weight gain for children undergoing chemotherapy for solid malignancies: An Investigator-Initiated, Open-Label, Multi-Center, Phase III Randomized Controlled Trial
|
| Trial Acronym |
SNOWMAN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sameer Bakhshi |
| Designation |
Professor & Head of Medical Oncology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Office of Head of Department
Second floor
Dr Bhim Rao Ambedkar Institute Rotary Cancer Hospital,
All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South West
DELHI
110023
India |
| Phone |
9958828763 |
| Fax |
|
| Email |
sambakh@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sameer Bakhshi |
| Designation |
Professor & Head of Medical Oncology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Office of Head of Department
Second floor
Dr Bhim Rao Ambedkar Institute Rotary Cancer Hospital,
All India Institute of Medical Sciences, Ansari Nagar, New Delhi
New Delhi
Delhi
South West
DELHI
110023
India |
| Phone |
9958828763 |
| Fax |
|
| Email |
sambakh@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sameer Bakhshi |
| Designation |
Professor & Head of Medical Oncology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Office of Head of Department
Second floor
Dr Bhim Rao Ambedkar Institute Rotary Cancer Hospital,
All India Institute of Medical Sciences, Ansari Nagar, New Delhi
New Delhi
Delhi
South West
DELHI
110023
India |
| Phone |
9958828763 |
| Fax |
|
| Email |
sambakh@hotmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| CanKids KidsCan - The National Society for Change for Childhood Cancer in India |
|
|
Primary Sponsor
|
| Name |
Prof Sameer Bakhshi PI |
| Address |
Department of Medical Oncology
Dr BRAIRCH
AIIMS New Delhi
Delhi 110029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Venkataraman Radhakrishnan |
Adyar Cancer Institute |
Department of Medical Oncology Adyar Cancer Institute (WIA) Guindy National Park, Adyar, Chennai, Tamil Nadu 600020
Chennai
TAMIL NADU |
9958828763
venkymd@gmail.com |
| Prof Sameer Bakhshi |
All India Institute of Medical Sciences, New Delhi |
Department of Medical Oncology and Pediatric Surgery, AIIMS, New Delhi-110023
South West
DELHI |
9958828763
sambakh@hotmail.com |
| Dr Prasanth Ganesan |
Jawaharlal Institute of Postgraduate Medical Education & Research |
Department of Medical Oncology JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY |
9444216310
pg1980@gmail.com |
| Prof Sameer Bakhshi |
National Cancer Institute- AIIMS Jhajjar (Campus under AIIMS, New Delhi) |
Department of Medical Oncology NCI- AIIMS Campus Badsa, Jhanjrola, Jhajjar, Haryana 124105
Jhajjar
HARYANA |
9958828763
sambakh@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IEC Cancer Institute (WIA) |
Approved |
| IEC Intervention Studies JIPMER |
Approved |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C400||Malignant neoplasm of scapula andlong bones of upper limb, (2) ICD-10 Condition: C401||Malignant neoplasm of short bonesof upper limb, (3) ICD-10 Condition: C402||Malignant neoplasm of long bones of lower limb, (4) ICD-10 Condition: C403||Malignant neoplasm of short bonesof lower limb, (5) ICD-10 Condition: C408||Malignant neoplasm of overlappingsites of bone and articular cartilage of limb, (6) ICD-10 Condition: C419||Malignant neoplasm of bone and articular cartilage, unspecified, (7) ICD-10 Condition: C490||Malignant neoplasm of connective and soft tissue of head, face and neck, (8) ICD-10 Condition: C499||Malignant neoplasm of connective and soft tissue, unspecified, (9) ICD-10 Condition: C641||Malignant neoplasm of right kidney, except renal pelvis, (10) ICD-10 Condition: C642||Malignant neoplasm of left kidney,except renal pelvis, (11) ICD-10 Condition: C692||Malignant neoplasm of retina, (12) ICD-10 Condition: C741||Malignant neoplasm of medulla of adrenal gland, (13) ICD-10 Condition: C491||Malignant neoplasm of connective and soft tissue of upper limb, including shoulder, (14) ICD-10 Condition: C492||Malignant neoplasm of connective and soft tissue of lower limb, including hip, (15) ICD-10 Condition: C222||Hepatoblastoma, (16) ICD-10 Condition: C629||Malignant neoplasm of testis, unspecified whether descended or undescended, (17) ICD-10 Condition: C499||Malignant neoplasm of connective and soft tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Olanzapine |
Olanzapine tablets daily for 12 weeks along with standard dietary counselling.
Dose of 1.25 mg for body weight 10 to 20 kg and 2.5 mg tablet for more than or equal to 20 kg body weight
|
| Comparator Agent |
Standard dietary counselling |
Dietary counselling by experienced dietician with age and sex appropriate caloric and protein content |
|
Inclusion Criteria
Modification(s)
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
a) Children and adolescents aged 2 to <18 years at the time of enrolment
b) Body weight of atleast 10 kilograms
c) Diagnosis of a solid malignancy
d) Chemotherapy/ Radiotherapy naïve
e) Planned to be initiated on first cycle of chemotherapy
|
|
| ExclusionCriteria |
| Details |
1 Overweight and obese children or adolescents (For children aged 2 years and above to less than 5 years: obesity shall be defined as per World Health Organization (WHO) as a weight-for-height (WFH) Z-score greater than three; For children and adolescents aged 5 years and above up to 18 years, obesity shall be defined as per Indian Academy of Pediatrics (IAP) as a body-mass index (BMI) Z-score greater than 1.33 in boys and 1.63 in girls)
2 Children who are not planned to be initiated on chemotherapy
3 Intake of olanzapine for more than 5 days per month for non trial indication
4 Children taking antipsychotics or antidepressants for any psychiatric or non psychiatric indication
5 Prolonged use of systemic corticosteroids Prednisolone or prednisolone-equivalent of more than or equal to 5 mg for more than a week in the previous 28 days.
6 Children with intracranial neoplasms
7 Children with hematological malignancies
8 Children with intellectual disability
9 Children with concomitant chronic infections like osteomyelitis, tuberculosis, meningitis, suppurative infections, etc.
10 Inability to take oral medications
11 Severe organ damage based on laboratory investigations within 2 weeks at the time of screening (hepatic- transaminitis more than or equal to 5 times upper limit normal or bilirubin more than or equal to three times upper limit of normal; renal- serum creatinine levels more than or equal to 1.5 times upper limit of normal; any evidence of heart failure)
12 Qtc interval prolongation: more than or equal to 450 msec by Fredericia formula
13 Raised serum amylase levels (more than upper limit normal) |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of children achieving weight gain more than or equal to 5 percentage at the end of 12 weeks of receipt of olanzapine plus standard dietary counselling versus standard dietary counselling alone among those undergoing chemotherapy for solid malignancies |
3 weeks 6 weeks 9 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in anorexia scores |
3 weeks 6 weeks 9 weeks and 12 weeks |
| Change in quality of life |
6 weeks and 12 weeks |
| Change in anthropometric parameters |
3 weeks 6 weeks 9 weeks and 12 weeks |
| Event free survival and Overall survival |
12 weeks |
| Improvement in caloric intake |
3 weeks 6 weeks 9 weeks and 12 weeks |
| Adverse effect profile |
3 weeks 6 weeks 12 weeks |
| Grade 3 or 4 chemotoxicity assessment |
3 weeks 6 weeks 9 weeks and 12 weeks |
|
|
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)
|
29/03/2024 |
| 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) |
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
|
Cancer cachexia has a profound impact on the survival of cancer
patients and it is estimated that it is responsible for almost a quarter of
deaths among cancer patients. Notably, poor nutritional status also affects
chemotherapy tolerance and enhances the susceptibility to infections.
Malnutrition also alters the body composition and thereby the pharmacokinetics
of chemotherapeutic modalities. This culminates in delayed recovery of marrow
functions and delay in treatment which has an unfavorable impact on the overall
response to therapy. Hence there is an unmet need to develop or find agents for
improving appetite and maintaining body composition among cancer patients to
reverse this state of negative energy balance which would likely have an impact
on clinically relevant outcomes like overall survival. As we are progressing towards a global improvement in pediatric
cancer cure rates and survival, it is imperative that we deal with other
factors which have key impact on the development and neuro-cognition of
pediatric cancer survivors.
There is a serious dearth of academic publications and well
conducted trials catering to the nutrition interventions for improving outcomes
in pediatric oncology practice. This trial aims to address this unmet need and
plans to explore olanzapine as a therapeutic modality in causing weight gain
and improving appetite among pediatric patients with solid malignancies.
Olanzapine is an easily available, safe and well-tolerated drug which has
pleiotropic effects among cancer patients. It can be a useful addition to the
therapeutic armamentarium for nutritional improvement among children with
cancer. In this trial, we intend to demonstrate weight gain along with
improvement in appetite, anorexia, anthropometric parameters and quality of
life using olanzapine in children undergoing chemotherapy for solid
malignancies. This shall be an open-label, investigator-initiated, multicenter, randomized phase 3 clinical trial with a proposed sample size of 140 patients. These shall be children with therapy naive solid malignancies in the age group of 2-18 years and will be randomized 1:1 into Arm A (Olanzapine tablet daily for 12 weeks + standard dietary counselling) or Arm B (Standard dietary counselling for 12 weeks). Primary outcome shall be to observe the proportion of children with weight gain of more than or equal to 5 percentage. |