Objectives- This trial was designed for asessment of lycopene effect on cisplatin induced nephropathy
Design- Clinical randomized trial, not blinded, mono centric, without placebo.
Participants- 120 people were selected from the patients referring to the hematology and oncology clinic of the Shahrekord university of medical sciences by convenience sampling. The inclusion criteria were patients to be suffering cancer without primary involvement or renal metastasis; being candidate for administration of 70-100 mg/m2 cisplatin; being 20-80 years old; Cr < 1.5; normal hearing; no underlying nephropathy; and the performance status of 0-2. Exclusion criteria were occuring death; allergy to lycopene; hearing loss; significant neuropathy; metastatic kidney involvement.
Intervention- We assigned the patients randomly into two groups of cases and controls. The control group was treated with cisplatin and a standard regimen of kidney injury prevention (hydration+ sulphate magnesium). The case group were administered with 25mg twice a day lycopene 24hrs before until 72hrs after cisplatin injection+ cisplatin alongside a regimen of kidney injury prevention (hydration+ sulphate magnesium).
Variables- Serum Cr, BUN measured when admission then after 3 and 21 days. GFR calculated with Crockroft-Gault formula.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050427745N1
Registration date:2016-07-31, 1395/05/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-31, 1395/05/10
Registrant information
Name
Leyla Mahmoodnia
Name of organization / entity
Shahrekord university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
mahmoodnia.l@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahr-e-Kord medical university
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preventive effect of lycopene on cisplatin nephrotoxicity in cancer patient
Public title
Lycopene nephrotoxicity prevention in cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria were condidered to be suffering cancer without primary involvement or renal metastasis; being candidate for administration of 70-100 mg/m2 cisplatin; being 20-80 years old; Cr < 1.5; normal hearing; no underlying nephropathy; ; performance status of 0-2.
Exclusion criteria were death; allergy to lycopene; hearing loss; moderate to severe neuropathy; renal metastatic involvement.
Age
From 20 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical ethics committee of Shahrekord university of medical sciences
Street address
Central organization of medical university, Kashani st.
City
Shahrekord
Postal code
8815713471
Approval date
2016-02-22, 1394/12/03
Ethics committee reference number
IR.SKUMS.rec.1394.271
Health conditions studied
1
Description of health condition studied
Drug induced nephropathy
ICD-10 code
N14.1
ICD-10 code description
Nephropathy induced by other drugs, medicaments and biological substances
Primary outcomes
1
Description
BUN
Timepoint
Before intervention, 7 & 21 days lft
Method of measurement
mg/dl - labratuary
2
Description
Cr
Timepoint
Before intervention, 7 & 21 days lft
Method of measurement
mg/dl - labratuary
3
Description
GFR
Timepoint
Before intervention, 7 & 21 days lft
Method of measurement
ml/min - calculation
Secondary outcomes
empty
Intervention groups
1
Description
Lycopene 25mg tablet bid 24hr before until 72hr left after cisplatin injection and an standard regimen of kidney injury prevention (hydration+sulphate magnesium).
Category
Treatment - Drugs
2
Description
Cisplatin and an standard regimen of kidney injury prevention (hydration+sulphate magnesium).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali medical clinic
Full name of responsible person
Mrs. Fatemeh Nasiri
Street address
Emam Ali medical clinic, Shariaati st, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord university of medical sciences
Full name of responsible person
Dr. Kamal Solatti
Street address
Central organization of medical university, Kashani st.
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahrekord university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord university of medical sciences
Full name of responsible person
Keivan Mohammadi
Position
MD
Other areas of specialty/work
Street address
No.5, Hacoupian building, Saadi blvd.
City
Esfahan
Postal code
Phone
+98 31 3624 7985
Fax
Email
k1mohamadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord university of medical sciences
Full name of responsible person
Keivan Mohammadi
Position
MD
Other areas of specialty/work
Street address
No.5, Hacoupian building, Saadi blvd.
City
Esfahan
Postal code
Phone
+98 31 3624 7985
Fax
Email
k1mohamadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord university of medical sciences
Full name of responsible person
Keivan Mohammadi
Position
MD
Other areas of specialty/work
Street address
No.5, Hacoupian building, Saadi blvd.
City
Esfahan
Postal code
Phone
+98 31 3624 7985
Fax
Email
k1mohamadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)