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Effect of lovastatin on response rate and acute side effects of chemoradiation in locally advanced head and neck squamous cell carcinoma: A phase III randomized clinical trial

Protocol summary

Summary
This study is a phase 3 double blind randomized clinical trial that include 35 patients with locally advanced SCC of oral cavity,larynx and hypopharynx who referred for definitive chemoradiation in Tehran Cancer Institute. These patients should not have underlying liver or kidney disease and not receive any drug that interferes with metabolism of lovastatin. These patients will be randomized into 2 groups. One group receive standard chemoradiation concurrent with 80 mg daily lovastatin, divided into 4 doses, and another group receive standard treatment concurrent with placebo, in the same manner. With the initiation of possible side effects of lovastatin which include myopathy and liver toxicity, the patient will be excluded from trial. The main objective of this trial is to compare response rate between the two groups, that will be evaluated with spiral CT scan, 3 months after treatment. moreover, acute side effects of treatment such as neutropenia, anemia, thrombocytopenia, oral mucositis, dermatitis and dysphagia will be compared between the 2 groups, through physical examination and laboratory data, at the last week of treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014121920368N1
Registration date: 2015-12-03, 1394/09/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-03, 1394/09/12
Registrant information
Name
Ehsan Karbasi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 7001
Email address
ekarbasi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-06-30, 1394/04/09
Expected recruitment end date
2016-03-17, 1394/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lovastatin on response rate and acute side effects of chemoradiation in locally advanced head and neck squamous cell carcinoma: A phase III randomized clinical trial
Public title
Effect of lovastatin on treatment of head and neck cancers
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: pathologic evidence of locally advanced(T3,T4,N+) SCC of oral cavity,larynx and hypopharynx; being candidated for definitive chemoradiation; absence of underlying liver or kidney disease; not receiving any drug that interferes with metabolism of lovastatin. Exclusion criteria: initiation of possible lovastatin side effects such as myopathy and liver toxicity; inability to swallow lovastatin tablets
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
tehran university of medical sciences
Street address
6th floor,central university committee,Qods avenue corner,keshavarz boulvard
City
tehran
Postal code
Approval date
2012-09-16, 1391/06/26
Ethics committee reference number
130/1291/د/91

Health conditions studied

1

Description of health condition studied
Head and Neck Cancer
ICD-10 code
C32, C01,
ICD-10 code description
Malignant neoplasm of larynx, Malignant neoplasm of base of tongue, Malignant neoplasm of hypopharynx

Primary outcomes

1

Description
response rate
Timepoint
3 months after treatment
Method of measurement
via CT scan

Secondary outcomes

1

Description
acute side effects of treatment
Timepoint
last week of treatment
Method of measurement
physical examination and lab tests

Intervention groups

1

Description
Intervention group: lovastatin oral tablet, 20 mg, QID, in days of treatment
Category
Treatment - Drugs

2

Description
Control group: placebo, oral tablet, QID, in days of treatment
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Cancer Institute
Full name of responsible person
Ehsan Karbasi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Karbasi
Street address
Tehran Cancer Institute
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Ehsan Karbasi
Position
Radiation Oncology Resident
Other areas of specialty/work
Street address
Tehran Cancer Institute
City
Tehran
Postal code
Phone
+98 21 8868 7001
Fax
Email
ekarbasi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Radiation Oncology Research Center, Tehran University of Medical Sciences
Full name of responsible person
Mahdi Aghili
Position
Associated Professor
Other areas of specialty/work
Street address
Tehran Cancer Institute, Imam Khomeini Hospital Complex
City
Tehran
Postal code
Phone
+98 21 6119 2585
Fax
Email
aghili@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Karbasi
Position
Resident
Other areas of specialty/work
Street address
Tehran Cancer Institute
City
Tehran
Postal code
Phone
+98 21 8868 7001
Fax
Email
ekarbasi@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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