Evaluation of the effect of oral zinc sulfate with placebo on the prevention of chemotherapy-induced oral mucositis in patients treated with adriamycin and cyclophosphamide
Determining and comparing the effect of oral zinc sulfate with placebo on the prevention of chemotherapy-induced oral mucositis
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 3 on 92 patients
Settings and conduct
In this randomized double-blind clinical trial study, 92 patients with cancer who are candidates for chemotherapy containing adriamycin and cyclophosphamide referred to Seyed Al-Shohada Hospital in Isfahan will be randomly divided into two groups. One group will receive zinc sulfate and the other group will receive a placebo. Then the incidence of oral mucositis, pain and quality of life of patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria included cancer (based on biopsy), candidate for chemotherapy containing adriamycin and cyclophosphamide, having normal serum zinc levels, and consent to participate in the study. Exclusion criteria are pre-study oral mucositis.
Intervention groups
Intervention group: when starting chemotherapy treatment, patients take two capsules of zinc sulfate (Alhavi Company) daily with food for 12 weeks. Control group: when starting chemotherapy treatment, patients take two placebo capsules(Alhavi Company) daily with food for 12 weeks.
Main outcome variables
Incidence of oral mucositis; the pain; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150304021338N2
Registration date:2021-02-11, 1399/11/23
Registration timing:prospective
Last update:2021-02-11, 1399/11/23
Update count:0
Registration date
2021-02-11, 1399/11/23
Registrant information
Name
Mahnaz Roayaei
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 7396
Email address
roayaei@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-18, 1399/11/30
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral zinc sulfate with placebo on the prevention of chemotherapy-induced oral mucositis in patients treated with adriamycin and cyclophosphamide
Public title
Comparison of the effect of oral zinc sulfate on the prevention of chemotherapy-induced oral mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a biopsy-confirmed cancer.
Candidate for chemotherapy containing adriamycin and cyclophosphamide
Having a normal serum zinc level
Satisfaction to participate in the study
Exclusion criteria:
Infection of the oral mucosa before the study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, two drugs, oral zinc sulfate and placebo, in terms of shape and color, are prepared in the same way and provided to the researcher. They also prescribe them without knowing the type of any of the drugs. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Center of Medical Research - Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81745319
Approval date
2020-07-03, 1399/04/13
Ethics committee reference number
IR.MUI.MED.REC.1399.277
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast of unspecified site
Primary outcomes
1
Description
Pain
Timepoint
Before starting chemotherapy and once every three weeks for up to 12 weeks
Method of measurement
Visual Analog Scale (VAS)
2
Description
Incidence of oral mucositis
Timepoint
Before starting chemotherapy and once every three weeks for up to 12 weeks
Method of measurement
Observation
3
Description
Quality of Life
Timepoint
Before starting chemotherapy and once every three weeks for up to 12 weeks
Method of measurement
Cancer Patients Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: when starting chemotherapy treatment, patients take two placebo capsules(Alhavi Company) daily with food for 12 weeks.
Category
Placebo
2
Description
Intervention group: when starting chemotherapy treatment, patients take two capsules of zinc sulfate (Alhavi Company) daily with food for 12 weeks.