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Effect of rice bran arabinoxylan (MGN-3) on immune function in patients with breast and colorectal cancer: a prospective, open-label, single-arm clinical trial

Effect of rice bran arabinoxylan (MGN-3) on immune function in patients with breast and colorectal cancer: a prospective, open-label, single-arm clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056886
Enrollment
Unknown
Registered
2022-02-22
Start date
2022-03-10
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer, colorectal cancer

Interventions

Experimental group:MGN-3

Sponsors

Circle Harmony Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patient signed the informed consent voluntarily; 2. Breast cancer or colorectal cancer patients with stable disease after surgery, chemotherapy or radiotherapy; 3. Able to complete questionnaires and diet records; 4. Willingness to eat meals provided for 45 consecutive days; 5. Drink less than or equal to one drink per day.

Exclusion criteria

Exclusion criteria: 1. Patients with fistula; 2. History of food allergies and/or major dietary restrictions; 3. Take any functional foods and dietary supplements other than MGN-3 (except those that can be stopped during the study); 4. Pregnancy, lactation or planned pregnancy; 5. Self-reported smoking status; 6. History of gallstones; 7. Active or previously documented autoimmune or inflammatory disease within the past 5 years, excluding vitiligo or alopecia, stable hypothyroidism after hormone replacement therapy, and any chronic skin condition that does not require systemic treatment. Patients with stable chronic conditions, including diabetes, hypertension and chronic obstructive pulmonary disease, were not excluded.

Design outcomes

Primary

MeasureTime frame
Change from baseline in patient NK cell levels;

Secondary

MeasureTime frame
Change from baseline in levels of CD4 +, CD8 +, B cells, NKT cells, DC cells, Treg cells, ?d T cells;Change from baseline in cytokine profile (IL-1ra, IL-1ß, IL-2, IL-6, IL-10, IL-12, IL-17, IFN-?, TNF -a);Changes from baseline in the European Organization for Research in the Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30 v3.0);Changes in body weight, muscle mass, percentage body fat, BMI, neutrophil to lymphocyte ratio (NLR), and inflammatory nutrition index (INI) from baseline;Intestinal flora;

Countries

China

Contacts

Public ContactXu Qing

Circle Harmony Health

xuqing20220218@163.com+86 21 36810099

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026