| CTRI Number |
CTRI/2024/02/063329 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trial of beta sitosterol for prostate cancer |
|
Scientific Title of Study
|
Randomized, Double-blind, Placebo-controlled, Pilot Study of Add-on Beta Sitosterol Supplementation on Treatment Response in Prostate Cancer Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Juhi Mittal |
| Designation |
Junior Resident, Department of Pharmacology, AIIMS New Delhi |
| Affiliation |
AIIMS New Delhi |
| Address |
Lab.5004 Fifth Floor Convergence AIIMS New Delhi
New Delhi
DELHI
110049
India |
| Phone |
7790936838 |
| Fax |
|
| Email |
juhimittal03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Gupta |
| Designation |
Additional Professor, Department of Pharmacology, AIIMS New Delhi |
| Affiliation |
AIIMS New Delhi |
| Address |
Lab.5004 Fifth Floor Convergence AIIMS New Delhi
New Delhi
DELHI
110049
India |
| Phone |
26549257 |
| Fax |
|
| Email |
drgupta.pooja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Gupta |
| Designation |
Additional Professor, Department of Pharmacology, AIIMS New Delhi |
| Affiliation |
AIIMS New Delhi |
| Address |
Lab.5004 Fifth Floor Convergence AIIMS New Delhi
New Delhi
DELHI
110049
India |
| Phone |
26549257 |
| Fax |
|
| Email |
drgupta.pooja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Director, AIIMS, Ansari Nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS, Ansari Nagar, New Delhi- 110029 |
| 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 Juhi Mittal |
AIIMS New Delhi |
Department of Pharmacology, AIIMS, New Delhi; Department of Urology, AIIMS, New Delhi; Department of Medical Oncology, Institute Rotary Cancer Hospital (IRCH), New Delhi.
New Delhi
DELHI |
7790936838
juhimittal03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Beta Sitosterol |
320mg OD capsule for 3 months |
| Comparator Agent |
Placebo |
Matching placebo capsules OD for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
1. Males, age≥18 years
2. Histologically proven prostate adenocarcinoma
3.Metastatic prostate cancer on ADT+/- Abiraterone acetate +/- Chemotherapy +/- Antiandrogen
|
|
| ExclusionCriteria |
| Details |
1. Brain or Leptomeningeal metastasis
2. Bilirubin, AST or ALT more than 2.5 times of the upper limit of normal levels.
3. Currently active Inflammatory bowel disease or Inflammatory bowel syndrome
4. History of any other malignancy in the last five years
5. History of recent surgery within 4 weeks of enrolment
6. Patients who are not willing to participate and will not provide signed informed consent
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in PSA (Prostate specific antigen) levels |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Plasma Ceramide levels & Quality of life |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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)
|
Not Applicable |
| 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
|
Prostate cancer is the second most frequent cancer diagnosis made in men and fourth most common cancer overall. There is a need to explore for safer and more efficient prostate cancer treatment. Standard systemic therapy(Androgen Deprivation therapy +/- Abiraterone Acetate ) for prostate cancer only improves 3 year overall survival by 76-83%. In addition, it is possible for upto 47% of these patients to experience serious adverse effects. Beta Sitosterol is a safe supplement which has demonstrated promising anticancer activity against prostate and other types of cancers in preclinical in vitro and in vivo studies. More clinical research is needed to demonstrate the anticancer effect of beta sitosterol in real life prostate cancer patients. This study aims to find out the effect of Beta Sitosterol as add on therapy with ongoing standard of care (SOC) on treatment response in persons with prostate cancer. After enrolment in this study, a detailed history about patient’s prostate cancer, its on-going treatment and various lab investigations will be obtained. Each patient will get an equal chance to be enrolled into either of the two groups where one group will receive Beta Sitosterol supplementation and another will receive a placebo for 3 months of duration along with on-going SOC treatment. There will be no change in the SOC treatment regimen during the intervention period. Patients will be followed-up for 3 months period. Primary outcome will be assessed in terms of change in PSA (Prostate specific antigen) levels at 3 months. |