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General information
Triple blinded
Double blinded
tripldoubl
1
1
24
26
2426
Protocol summary
Study aim
Evaluating the effects of nano-curcumin on adverse effects and response of neoadjuvant chemotherapy in bladder cancer patients
Design
randomized, double-blind, placebo-controlled design pilot study
Settings and conduct
this trial is conducted at Shoda-e-tajrish hospital. Whereas patients and physicians allocated to the intervention group are kept blinded to the allocation , outcome assessors and data analysts are aware of the allocation arm.”
Participants/Inclusion and exclusion criteria
patients with histologically confirmed muscle-invasive urothelial cell carcinoma of the bladder
ECOG performance status of 0 or 1
Evidence of lymph node (N+) or distant metastasis (M1) in the screening imaging assessment
Intervention groups
Patients were randomly assigned to receive either chemotherapy without (arm A) or with NanoCurcumin(armB) . Arm A patients were administered gemcitabine (1000 mg/m2, intravenous ,30 min) on days 1 and 8, every 21 days. Following gemcitabine administration, patients with a creatinine clearance 60 ml/min/m2 received cisplatin every 21 days (70 mg/m2, 60 min) whereas those with a creatinine clearance <60 ml/min/m2 received carboplatin (AUC = 5, IV over 30 min) on day 1 every 21 days. Carboplatin doses were adjusted for renal function as per label using the Cockcroft-Gault formula and withheld in cases of significant renal deterioration. Patients in group B received the same protocol in combination with SinaCurcumin oral capsules (Exir Nano, Tehran, Iran) SinaCurcumin is a registered product from curcuminoids in Iran (IRC: 1228225765 ). Each soft gelatin capsule of SinaCurcumin contains 80 mg curcuminoids as nanomicelles.
Evaluating The Effects of Nano-Curcumin On Adverse Effects And Response Of Neoadjuvant Chemotherapy In Bladder Cancer Patients
Public title
Effect of Nano-Curcumin On Neoadjuvant Chemotherapy of Bladder Cancer Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with TCC of Bladder
ECOG performance of 0 or 1
candidate to receive neoadjuvant chemotherapy
Exclusion criteria:
Metastatic disease
age under 18 or over 80
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
24
Actual sample size reached:
26
Randomization (investigator's opinion)
Randomized
Randomization description
A web-based randomized form was prepared using random permuted-block randomization technique. patient allocation was done according to the randomized list.
Blinding (investigator's opinion)
Double blinded
Blinding description
all participants and investigators including physicians were blinded. allocation of patients was based on a randomized list and patients received curcumin and placebo in a similar package.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Shahid Beheshti University of Medical Sciences
Street address
SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2017-07-11, 1396/04/20
Ethics committee reference number
IR.SBMU.MSP.REC.1396.227
Health conditions studied
1
Description of health condition studied
Bladder Cancer
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder
Primary outcomes
1
Description
Clinical complete response to chemotherapy
Timepoint
4 weeks after completion of chemotherapy
Method of measurement
cystoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Nanocurcumin 80 mg capsules manufactured by Exir Nano Sina are taken by patients two times daily for 12 weeks during chemotherapy
Category
Treatment - Drugs
2
Description
Control group: Placebo capsules manufactured by Exir Nano Sina which contains starch are taken by patients two times daily for 12 weeks during chemotherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
saleh sandoughdaran
Street address
Shohadaye Tajrish Hospital, Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25715
Email
sandoughdaran@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 6647 5941
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saleh Sandoughdaran
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Shohadaye Tajrish Hospital, Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 4442 0082
Email
sandoughdaran@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saleh Sandoughdaran
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Shohadaye Tajrish Hospital, Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 4442 0082
Email
sandoughdaran@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saleh Sandoughdaran
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Shohadaye Tajrish Hospital, Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 4442 0082
Email
sandoughdaran@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD