- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04998994
The Effects of Wheat Sprouts Supplements on the Key Health Indicators of the Patients With Breast Cancer After Chemotherapy
August 3, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
To explore the effects of wheat sprouts supplements on the key health indicators of the patients with breast cancer after chemotherapy, Maiji tablets, a wheat sprouts supplement, were used to treat 26 patients during the progress of chemotherapy and nutritional status, immune function, quality of life were measured and evaluated.
Through data analysis, we found that Maiji tablets may improve the symptoms of appetite loss, nausea and vomiting, and fatigue in patients with breast cancer during chemotherapy.
Meanwhile it may help patients maintain weight, keep appetite and improve the food intake.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
patients diagnosed with breast cancer, receiving chemotherapy for the first time
Description
Inclusion Criteria:
- patients diagnosed with breast cancer, receiving chemotherapy for the first time
Exclusion Criteria:
- Patients with severe liver or kidney disease or other infectious diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of life
Time Frame: 28 days
|
Quality of life was measured by quality of life assessment form
|
28 days
|
|
weight
Time Frame: 28 days
|
the weight of patients
|
28 days
|
|
nutritional status
Time Frame: 28 days
|
nutritional status of patients
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 22, 2019
Primary Completion (Actual)
August 22, 2020
Study Completion (Actual)
October 1, 2020
Study Registration Dates
First Submitted
August 3, 2021
First Submitted That Met QC Criteria
August 3, 2021
First Posted (Actual)
August 10, 2021
Study Record Updates
Last Update Posted (Actual)
August 10, 2021
Last Update Submitted That Met QC Criteria
August 3, 2021
Last Verified
May 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2018-172
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.