The Effects of Wheat Sprouts Supplements on the Key Health Indicators of the Patients With Breast Cancer After Chemotherapy

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04998994
• Collaborator: First Affiliated Hospital of Wenzhou Medical University (Other), Quzhou Kecheng People's Hospital (Other), Beijing Shijitan Hospital, Capital Medical University (Other), Jinhua Municipal Central Hospital (Other), Zhejiang Cancer Hospital (Other)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 17.3
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nutritional Status, Immune Function, Quality of Life Uring the Progress of Chemotherapy	Dietary Supplement: wheat sprouts supplement

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The Effects of Wheat Sprouts Supplements on the Key Health Indicators of the Patients With Breast Cancer After Chemotherapy
• Actual Study Start Date: Apr 22, 2019
• Actual Primary Completion Date: Aug 22, 2020
• Actual Study Completion Date: Oct 1, 2020

Outcome Measures

Primary Outcome Measures

1. quality of life [28 days]

   Quality of life was measured by quality of life assessment form

2. weight [28 days]

   the weight of patients

3. nutritional status [28 days]

   nutritional status of patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University
• 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04998994
• Other Study ID Numbers: 2018-172
• First Posted: Aug 10, 2021
• Last Update Posted: Aug 10, 2021
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 10, 2021