Evaluation of the effects of propolis- echinacea supplementation on Chronic fatigue syndrome and quality of life in lung cancer patients (NSCLC) consuming Pemetrexed
Evaluation of the effects of propolis-echinacea supplementation on chronic fatigue syndrome and quality of life in lung cancer patients (NSCLC) consuming pemetrexed
Design
Clinical trial, single group, phase 3 on 40 patients, enrolled from patients who refer to Masih Daneshvari Hospital with a diagnosis of NSCLC and are candidates to receive pemetrexed for the first time.
Settings and conduct
This clinical trial and prospective study of before-after will take place in the Masih Daneshvari Hospital. Forty patients diagnosed with NSCLC by an oncologist according to NCCN protocols. These patients are candidates to receive pemetrexed. Fatigue and quality of life in the patients will be assessed with EQ-5F-3L and BFI questionnaires. Finally, the effects of intervention will be evaluated following completing the questionnaires and analyzing data by SPSS software and statistical analyses.
Participants/Inclusion and exclusion criteria
The inclusion criteria include patients who refer to Masih Danshvari hospital with a diagnosis of NSCLC and are candidates for receiving pemetrexed for the first time. Exclusion criteria also include patients who are allergic to drugs, suffering from underlying nerve disorders, patients addicted to drugs, patients using hypnotics and neuroleptics, patients with
Hypothyroidism and patients who need surgery and are pregnant and lactating.
Intervention groups
Propolis- echinacea supplement tablet of 450 mg twice daily for one month patients with lung cancer patients (NSCLC) consuming pemetrexed.
Main outcome variables
Fatigue status and quality of life in non-small cell lung cancer (NSCLC) patients using Pemetrexed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N33
Registration date:2023-05-20, 1402/02/30
Registration timing:prospective
Last update:2023-05-20, 1402/02/30
Update count:0
Registration date
2023-05-20, 1402/02/30
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of propolis- echinacea supplementation on Chronic fatigue syndrome and quality of life in lung cancer patients (NSCLC) consuming Pemetrexed
Public title
Evaluation of the effects of propolis- echinacea supplementation on Chronic fatigue syndrome and quality of life in lung cancer patients (NSCLC) consuming Pemetrexed
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Lung cancer patients (NSCLC) consuming Pemetrexed
Exclusion criteria:
Patients who are allergic to medicine
Patients with hypothyroidism
Patients using hypnotics and neuroleptics
Patients addicted to drugs
Suffering from underlying nerve disorders
Patients who need surgery
Pregnant and lactating
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Pharmacy, Nursing and Midwifery Faculties - Shahid Beheshti Universi
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
1991953381
Approval date
2023-01-10, 1401/10/20
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.220
Health conditions studied
1
Description of health condition studied
Non-small cell lung cancer (NSCLC)
ICD-10 code
C34.9
ICD-10 code description
Malignant neoplasm of unspecified part of bronchus or lung
Primary outcomes
1
Description
Quality of life score based on EQ-5D-3L questionnaire
Timepoint
Measuring the quality of life based on the EQ-5D-3L questionnaire on days 0 and 28
Method of measurement
EQ-5D-3L questionnaire
2
Description
Fatigue complication score based on BFI questionnaire
Timepoint
Measurement of fatigue complication score based on BFI questionnaire on days 0-7-14-21-28
Method of measurement
BFI questionnaire
Secondary outcomes
1
Description
Hospitalization rate
Timepoint
Before intervention and one month after the end of intervention
Method of measurement
Patient’s record
2
Description
Rate of infection
Timepoint
Before intervention and one month after the end of intervention
Method of measurement
Patient’s record
Intervention groups
1
Description
Intervention group: Novohil drug manufactured by Faran Chemical Factory with a dose of 450 mg (containing 400 mg of propolis and 50 mg of echinacea) is administered orally to patients twice a day for one month.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Farzaneh dastan
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran