NCT04998994

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
Last Updated

August 10, 2021

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

August 3, 2021

Last Update Submit

August 3, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • quality of life

    Quality of life was measured by quality of life assessment form

    28 days

  • weight

    the weight of patients

    28 days

  • nutritional status

    nutritional status of patients

    28 days

Interventions

wheat sprouts supplementDIETARY_SUPPLEMENT

Maiji tablets, a wheat sprouts supplement, were used to treat 26 patients during the progress of chemotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with breast cancer, receiving chemotherapy for the first time

You may qualify if:

  • \- patients diagnosed with breast cancer, receiving chemotherapy for the first time

You may not qualify if:

  • \- Patients with severe liver or kidney disease or other infectious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 10, 2021

Study Start

April 22, 2019

Primary Completion

August 22, 2020

Study Completion

October 1, 2020

Last Updated

August 10, 2021

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations