Nanocurcumin role as an adjunctive therapy on treatment response and quality of life in patients with breast and gastrointestinal cancer resistant to treatment: Randomized clinical trial
Curcumin is a lipid-soluble compound extracted from the plant Curcuma Longa and can potentially prevent cancer development with no discernible toxicity. However, absorption, distribution, metabolism and excretory studies of curcumin in recent years focus on its low bioavailability in systemic circulation. Subsequently, many methods were tested to overcome this defect like the use of nanocurcumin. Our previous results shed new light on the potential biocompatibility, biodegradability and anticancer effects of nanocurcumin in the preclinical studies. Furthermore, our data in clinical phase I study showed that nanocurcumin can be tolerated even in high doses without any toxicity. Therefore, in the present study, we aimed nanocurcumin role as an adjunctive therapy with standard therapy on treatment response and quality of life in patients with breast and gastrointestinal cancer resistant to treatment. 40 patients were randomly selected into control and case groups; with breast cancer and colon cancer, referred to Institute cancer of Iran, from September 2014 to September 2015. The Functional Assessment of Cancer Therapy (FACT) and Questionnaire for Cancer Rehabilitation Evaluation System (CARES), and CT scan are used for estimation of quality of life and response to treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091418745N2
Registration date:2014-10-09, 1393/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-09, 1393/07/17
Registrant information
Name
Ali Mohammad Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2501
Email address
aalizadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Nanocurcumin role as an adjunctive therapy on treatment response and quality of life in patients with breast and gastrointestinal cancer resistant to treatment: Randomized clinical trial
Public title
Nanocurcumin role in patients with breast and gastrointestinal cancer resistant to treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Randomize; Pathology report of invasive breast and GI carcinoma; signed informed consent; resistant to treatment; metastatic disease.
Exclusion criteria: Less than 50% heart ejection fraction; heart failure; liver failure (liver enzymes more than 5 times of upper normal limit) or creatinine more than 2 mg/dl; low albumin<2; brain metastasis; sever diarrhea.
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Bulvar, Porsina Street
City
Tehran
Postal code
134511345
Approval date
2014-02-01, 1392/11/12
Ethics committee reference number
92-01-51-21039-92287
Health conditions studied
1
Description of health condition studied
Breast and GI cancers
ICD-10 code
c50-c50 an
ICD-10 code description
Breast, unspecified; Malignant neoplasms of digestive organs
Primary outcomes
1
Description
Response to treatment
Timepoint
Before and after drug therapy, 3 months
Method of measurement
CT scan
Secondary outcomes
1
Description
The assesment of quality of life
Timepoint
Befor and after of treatment, 3 months
Method of measurement
Questionnaires of FACT and CARES
Intervention groups
1
Description
12 tablet of nanocurcumin placebo per a day (3 tablet, QID) for three months except during chemotherapy
Category
Placebo
2
Description
12 tablet of nanocurcumin per a day (3 tablet, QID) for three months except during chemotherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute of Iran
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Street address
Keshavarz Bulvar, Institut of Cancer
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-زhancellor for Research of Tehran University of Medical Sciences
Full name of responsible person
Dr. Uonesian
Street address
Keshavarz Bulvar, Porsina Street.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-زhancellor for Research of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Ph.D, Assistant Professor
Other areas of specialty/work
Street address
Keshavarz Bulvar, Cancer Insitute of Iran, Cancer Research Center
City
Tehran
Postal code
13145158
Phone
+98 21 6119 2501
Fax
+98 21 6119 2501
Email
aalizadeh@razi.tums.ac.ir
Web page address
www.pccrg.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahdi Aghili, Dr. Ali Mohammad Alizadeh
Position
Associated professor, Assistant professor
Other areas of specialty/work
Street address
Keshavarz Bulvar, Cancer Institute of Iran
City
Tehran
Postal code
13145158
Phone
+98 21 6694 8672
Fax
+98 21 6119 2501
Email
aghili@tums.ac.ir
Web page address
www.pccrg.org
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical of Sciences
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Ph.D, Asistant Professor
Other areas of specialty/work
Street address
Keshavarz Bulvar, Institut of Cancer, Cancer Research Center
City
Tehran
Postal code
13145158
Phone
+98 21 6119 2501
Fax
+98 21 6119 2501
Email
aalizadeh@razi.tums.ac.ir
Web page address
www.pccrg.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)