Nutritional Status, Immune Function, Quality of Life Uring the Progress of ChemotherapyNCT04998994
The Effects of Wheat Sprouts Supplements on the Key Health Indicators of the Patients With Breast Cancer After Chemotherapy
An observational study of Nutritional Status, Immune Function, Quality of Life Uring the Progress of Chemotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Nutritional Status, Immune Function, Quality of Life Uring the Progress of Chemotherapy
- What is being tested?
- wheat sprouts supplement
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2019to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed with breast cancer, receiving chemotherapy for the first time
Who may be able to join
- patients diagnosed with breast cancer, receiving chemotherapy for the first time
Who cannot join
- Patients with severe liver or kidney disease or other infectious diseases
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
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.
- Being tested
- wheat sprouts supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wheat sprouts supplementDietary supplement
Maiji tablets, a wheat sprouts supplement, were used to treat 26 patients during the progress of chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
Quality of life was measured by quality of life assessment form
Measured: 28 days
weight
the weight of patients
Measured: 28 days
nutritional status
nutritional status of patients
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start22 Apr 2019
- Primary completion22 Aug 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional Status, Immune Function, Quality of Life Uring the Progress of ChemotherapyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Quzhou Kecheng People's Hospital, Beijing Shijitan Hospital, Capital Medical University, Jinhua Municipal Central Hospital, Zhejiang Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998994
- Sponsor's protocol ID
- 2018-172
- Status last verified
- May 2019
- First submitted
- 3 Aug 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Wheat Sprouts Supplements on the Key Health Indicators of the Patients With Breast Cancer After Chemotherapy
- ClinicalTrials.gov ID
- NCT04998994
- Acronym / sponsor ID
- 2018-172
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Quzhou Kecheng People's Hospital, Beijing Shijitan Hospital, Capital Medical University, Jinhua Municipal Central Hospital, Zhejiang Cancer Hospital
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 22 Aug 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with breast cancer, receiving chemotherapy for the first time
Key inclusion criteria (1 listed)
- patients diagnosed with breast cancer, receiving chemotherapy for the first time
Key exclusion criteria (1 listed)
- Patients with severe liver or kidney disease or other infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wheat sprouts supplementMaiji tablets, a wheat sprouts supplement, were used to treat 26 patients during the progress of chemotherapy | Dietary supplement | – |
Primary outcome
quality of life
Time frame: 28 days
Quality of life was measured by quality of life assessment form
weight
Time frame: 28 days
the weight of patients
nutritional status
Time frame: 28 days
nutritional status of patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Status, Immune Function, Quality of Life Uring the Progress of Chemotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.