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Evaluation of herbal combination consists of Trigonella, Foeniculum, Chichorium, Hornleum and Glycine in the prevention of cancer-induced cachexia/anorexia of solid tumors’ patients: a randomized, double-blinded, placebo-controlled clinical trial

Protocol summary

Study aim
1) The evaluation of herbal combination in the body mass index, actual body weight, arm circumference, triceps muscle circumference, Anderson, Edmonton, FAACT criteria of solid tumors’ patients in comparison with placebo
Design
Two arms parallel group randomized trial with placebo, controlled-blinded group, and outcome assessment in 60 recruited patients between July 2018 till May 2019.
Settings and conduct
The study will be carried out in the clinic of seyedoshohada hospital, Isfahan. The investigator will recruit the patients and devote a special code to each participant. Then, the herbal combination or placebo will be given blindly to patients for four weeks. According to the study's endpoints, patients will be followed at baseline and after four weeks of herbal combination consumption.
Participants/Inclusion and exclusion criteria
All adult patients with advanced solid tumor malignancies who have cancer-induced anorexia or weight loss and received high doses of megestrol with no hepatic-, nephrotic- and gastrointestinal disorders. Patients with a known history of assessed herbal combination, cardiovascular disorder, diabetes, recent major surgy, taken corticosteroids or alcohol abuser will be excluded.
Intervention groups
Patients with solid tumors who are the candidate for receiving megestrol by a dose of 40 mg QID will be identified by physicians and investigator. The herbal combination and its placebo which were provided by Dineh company will be considered by the dose of 1 sachet three times a day for four weeks in both patients and control group.
Main outcome variables
The considered outcomes will be included, demographic patients characteristics, quality of life assessment, the criteria for anorexia and weight gain such as Edmonton, Anderson, FAACT criteria as well as anthropometrics criteria such as the increase in body weight, arm muscle circumference and triceps.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180722040556N1
Registration date: 2019-05-28, 1398/03/07
Registration timing: retrospective

Last update: 2019-05-28, 1398/03/07
Update count: 0
Registration date
2019-05-28, 1398/03/07
Registrant information
Name
Azadeh Moghaddas
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 7074
Email address
moghaddas@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-26, 1397/05/04
Expected recruitment end date
2019-03-15, 1397/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of herbal combination consists of Trigonella, Foeniculum, Chichorium, Hornleum and Glycine in the prevention of cancer-induced cachexia/anorexia of solid tumors’ patients: a randomized, double-blinded, placebo-controlled clinical trial
Public title
Trigonella, Foeniculum, Chichorium, Hornleum and Glycine in prevention of cancer-induced cachexia/anorexia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All adult patients (18 years and older) with advanced solid tumor malignancies (Stage 3-4) who encountered cancer-induced anorexia or weight loss (equal or greater than 5% of the previous weight before cancer diagnosis or within the last two months). Cancer patients with serum creatinine < 2 mg / dl. Cancer patients with serum total bilirubin < 2 mg / dl. Patients haven't had any sign of dysphagia or gastrointestinal obstruction. We have expected patients to be alive at least 3 upcoming months. Patients who have received high doses of megestrol due to cachexia and anorexia simultaneously.
Exclusion criteria:
Patients who have undergone major surgery for the last 4 weeks. Patients with a history of thrombophlebitis diseases. Patients who have been taking systemic corticosteroid within the last 4 weeks or concurrently. Patients who have cognitive impairment, psychiatric disorder or brain metastasis leading to cognitive impairment. Patients who have diabetes, uncontrolled blood pressure or advanced heart failure (NYHA 4) Patients who have consumed chronic alcohol. Patients who are pregnant or breast-feeding. Patients with a known hypersensitivity reaction to one of the plants in considered herbal combination
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the randomization will be carried out according to simple randomization via the random numbers obtained by Excell software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, we will use the doubled-blinded randomization in which both investigator and included patients will be blinded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Daneshgah street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-11-11, 1397/08/20
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.118

Health conditions studied

1

Description of health condition studied
Cancer-induced cachexia
ICD-10 code
C80.9
ICD-10 code description
C80.0

Primary outcomes

1

Description
Evaluation of herbal combination consists of Trigonella, Foeniculum, Chichorium, Hornleum, and Glycine in the prevention of cancer-induced cachexia/anorexia
Timepoint
Baseline and 4 weeks later
Method of measurement
Edmonton criteria

Secondary outcomes

1

Description
Quality of life
Timepoint
Baseline and four weeks later
Method of measurement
Iranian Version of the EORTC QLQ

Intervention groups

1

Description
Intervention group: Herbal combination including Trigonella, Foeniculum, Chichorium, Hornleum, and Glycine provided in Dineh company named General Tonic, one sachet three times a day for four weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyedoshohadda Hospital
Full name of responsible person
Azadeh Moghaddas
Street address
Daneshgah street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7074
Email
azadeh_moghaddas@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azadeh Moghaddas
Street address
Daneshgah street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7074
Email
azadeh_moghaddas@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azadeh Moghaddas
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshgah street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7074
Email
azadeh_moghaddas@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azadeh Moghaddas
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Isfahan University of medical Scienices, Daneshgah street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7074
Email
azadeh_moghaddas@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azadeh Moghaddas
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Isfahan University of medical Scienices, Daneshgah street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7074
Email
azadeh_moghaddas@yahoo.com

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 data can be shared
When the data will become available and for how long
ُStarting 6 months after publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
All required analyses can be applied
From where data/document is obtainable
Azadeh Moghaddas, Clinical Pharmacy Department, School of Pharmacy, Isfahan University of Medical Sciences, Hezarjarib street, Isfahan. moghaddas@pharm.mui.ac.ir
What processes are involved for a request to access data/document
After sending a request, we will call the related person and the data will be revealed in less than one week.
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