Protocol summary
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Study aim
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Evaluating the effects of nano-curcumin on adverse effects and response of neoadjuvant chemotherapy in bladder cancer patients
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Design
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randomized, double-blind, placebo-controlled design pilot study
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Settings and conduct
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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.”
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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clinical complete response;
chemotherapy associated hematologic adverse events
chemotherapy associated renal adverse events
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180226038875N1
Registration date:
2018-10-07, 1397/07/15
Registration timing:
retrospective
Last update:
2019-03-06, 1397/12/15
Update count:
1
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Registration date
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2018-10-07, 1397/07/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2016-09-22, 1395/07/01
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Expected recruitment end date
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2018-09-23, 1397/07/01
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Actual recruitment start date
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2016-09-22, 1395/07/01
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Actual recruitment end date
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2018-02-20, 1396/12/01
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Trial completion date
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2018-04-22, 1397/02/02
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Scientific title
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Evaluating The Effects of Nano-Curcumin On Adverse Effects And Response Of Neoadjuvant Chemotherapy In Bladder Cancer Patients
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Public title
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Effect of Nano-Curcumin On Neoadjuvant Chemotherapy of Bladder Cancer Patients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
24
Actual sample size reached:
26
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A web-based randomized form was prepared using random permuted-block randomization technique. patient allocation was done according to the randomized list.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-07-11, 1396/04/20
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Ethics committee reference number
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IR.SBMU.MSP.REC.1396.227
Health conditions studied
1
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Description of health condition studied
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Bladder Cancer
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ICD-10 code
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C67
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ICD-10 code description
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Malignant neoplasm of bladder
Primary outcomes
1
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Description
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Clinical complete response to chemotherapy
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Timepoint
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4 weeks after completion of chemotherapy
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Method of measurement
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cystoscopy
Intervention groups
1
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Description
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Intervention group: Nanocurcumin 80 mg capsules manufactured by Exir Nano Sina are taken by patients two times daily for 12 weeks during chemotherapy
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo capsules manufactured by Exir Nano Sina which contains starch are taken by patients two times daily for 12 weeks during chemotherapy
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available