Protocol summary
-
Study aim
-
Do cancer patients with beta thalassemia benefit more from erythropoietin than non-thalassemia ones?
Does chemotherapy induce less anemia in thalassemia patients among others?
-
Design
-
This is a four-arm open-label phase 3 clinical trial involving two control arms with parallel groups that will be performed on 72 patients. In the two main arms, thalassemia and non-thalassemia patients receive erythropoietin with each having a control arm. Randomization will be done with the printed table after stratification
-
Settings and conduct
-
This study will be performed in Shahid Rajaei hospital in Babolsar. After the initial tests, anemic patients are enrolled based on their anemia type.
-
Participants/Inclusion and exclusion criteria
-
Inclusion Criteria: Aged over 18; Metastatic cancer patients on first-line chemotherapy plan; Initial serum hemoglobin less than 13 g/dL
Exclusion Criteria: Leukemia/Plasma cell dyscrasia; Less than 3 months life expectancy; Major and intermedia thalassemia; Patients at risk for vascular thromboembolism; Taking any drug that raises risk of thromboembolism during chemotherapy; Pregnancy; Uncontrolled high blood pressure; A history of taking therapeutic radiopharmaceuticals in past three months; A history of blood transfusion within three months before trial initiation
-
Intervention groups
-
Intervention 1: Erythropoietin recipient thalassemia patients
Control 1: thalassemia patients not receiving erythropoietin
Intervention 2: Non-thalassemia patients receiving erythropoietin
Control 2: Non-thalassemia patients not receiving erythropoietin
-
Main outcome variables
-
serum hemoglobin level(g/dL); Dyspnea class(according to NYHA classes)
General information
-
Reason for update
-
To report the end of recruitment
-
Acronym
-
EPOTHAL
-
IRCT registration information
-
IRCT registration number:
IRCT20211202053252N1
Registration date:
2022-04-16, 1401/01/27
Registration timing:
prospective
Last update:
2024-06-04, 1403/03/15
Update count:
1
-
Registration date
-
2022-04-16, 1401/01/27
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2022-04-20, 1401/01/31
-
Expected recruitment end date
-
2025-04-20, 1404/01/31
-
Actual recruitment start date
-
2022-04-20, 1401/01/31
-
Actual recruitment end date
-
2024-03-24, 1403/01/05
-
Trial completion date
-
2024-06-04, 1403/03/15
-
Scientific title
-
Comparison of recombinant erythropoietin effect on serum hemoglobin of beta thalassemia minor versus non-thalassemia patients in chemotherapy candidates
-
Public title
-
Erythropoietin efficiency in thalassemia
-
Purpose
-
Prevention
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Aged over 18 years old
Metastatic cancer patients on first-line chemotherapy plan
Patients with visceral(confirmed with CT scan or MRI) or/and bone(less than 5-confirmed with bone scintigraphy) metastases
Initial serum hemoglobin less than 13 g/dL
Exclusion criteria:
Leukemia/Plasma cell dyscrasia
Less than 3 months life expectancy
Major and intermedia thalassemia based on hemoglobin electrophoresis
Patients at risk for vascular thromboembolism(e.g. history of venous thromboembolism or ischemic stroke, patients with metallic prostheses in heart or vessels(excluding coronary stents after one year of placement)
Taking drugs which effect on estrogen/progesterone receptor or any other drug that raises risk of thromboembolism during chemotherapy
Pregnancy
Uncontrolled high blood pressure(systolic BP over 160mmHg or diastolic BP over 95mmHg in three visits within a month despite treatment)
A history of taking therapeutic radiopharmaceuticals in past three months
A history of blood transfusion within three months before trial initiation
-
Age
-
From 18 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
72
Actual sample size reached:
72
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Random Stratified Sampling
Randomization method: Simple randomization
Randomization unit: Individual
Following determination of the treatment plan, patients are organized in different strata(due to the heterogeneity of the prevalence of cancers/effects of different chemotherapy regimens on the bone marrow) and then allocated in one of the four trial arms after randomization with the help of a random number table.
Attempts will be made to enroll equal number of patients in each strata of study arms which are mutually exclusive. These are as follows:
1- Candidates of platinum doublet chemotherapy regimens
2- Patients with breast cancer (excluding strata 1 patients)
3- Patients with gastrointestinal cancers (excluding strata 1 patients)
4- Other patients(excluding strata 1 patients)
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2022-03-06, 1400/12/15
-
Ethics committee reference number
-
IR.MUBABOL.HRI.REC.1400.257
Health conditions studied
1
-
Description of health condition studied
-
breast cancer
-
ICD-10 code
-
C50
-
ICD-10 code description
-
Malignant neoplasm of breast
2
-
Description of health condition studied
-
colon cancer
-
ICD-10 code
-
C18
-
ICD-10 code description
-
Malignant neoplasm of colon
3
-
Description of health condition studied
-
Rectal cancer
-
ICD-10 code
-
C20
-
ICD-10 code description
-
Malignant neoplasm of rectum
4
-
Description of health condition studied
-
Gastric cancer
-
ICD-10 code
-
C16
-
ICD-10 code description
-
Malignant neoplasm of stomach
5
-
Description of health condition studied
-
Esophageal cancer
-
ICD-10 code
-
C15
-
ICD-10 code description
-
Malignant neoplasm of esophagus
6
-
Description of health condition studied
-
Head & Neck cancer
-
ICD-10 code
-
C76
-
ICD-10 code description
-
Malignant neoplasm of other and ill-defined sites
7
-
Description of health condition studied
-
Thalassemia beta minor
-
ICD-10 code
-
D56.3
-
ICD-10 code description
-
Thalassemia minor
Primary outcomes
1
-
Description
-
Serum hemoglobin level
-
Timepoint
-
Before study, with each chemotherapy session
-
Method of measurement
-
Electrical-Impedance Cell Counting
2
-
Description
-
Shortness of breath
-
Timepoint
-
Before study, with each chemotherapy session
-
Method of measurement
-
Subjective _ According to NYHA Classification of dyspnea
Intervention groups
1
-
Description
-
Intervention group 1: Beta thalassemia patients receiving erythropoietin beta(CinnaPoietin; CinnaGen, Tehran, Iran) 150 IU/kg/day subcutaneously 3 days a week(Even days) for a minimum of 6 weeks and maximum of 6 months
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group 1: Thalassemia patients not receiving erythropoietin
-
Category
-
Lifestyle
3
-
Description
-
Intervention group 2: Patients without beta thalassemia receiving erythropoietin beta(CinnaPoietin; CinnaGen, Tehran, Iran) 150 IU/kg/day subcutaneously 3 days a week(Even days) for a minimum of 6 weeks and maximum of 6 months
-
Category
-
Treatment - Drugs
4
-
Description
-
Control group 2: Patients without beta thalassemia not receiving erythropoietin
-
Category
-
Lifestyle
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Babol 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Yes - There is a plan to make this available
-
Data Dictionary
-
Yes - There is a plan to make this available
-
Title and more details about the data/document
-
All of the deidentified data are to be released after publication of the study
-
When the data will become available and for how long
-
Within one month after publication
-
To whom data/document is available
-
Any academic institution can have access to data
-
Under which criteria data/document could be used
-
Data are not to be disclosed for anyone else
-
From where data/document is obtainable
-
Any interested scientist is expected to email the correspondent researcher
-
What processes are involved for a request to access data/document
-
The applicant should send an academic email with university affiliation(e.g. john@harvard.edu)
-
Comments
-