Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma

Breast Neoplasms Clinical Trial

Official title:

Phase 1 Study of Clinical Nutrition That Research Safty and Efficacy in Lung Neoplasms And Breast Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603016
• Other study ID #: PLAGHS201503601
• Status: Completed
• Phase: N/A
• First received: November 10, 2015
• Last updated: March 11, 2017
• Start date: November 2015
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the efficacy of clinical nutrition to treat lung neoplasms and breast carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE compound,120 patients will recrive Maitake mushroom extract compound,120 patients will recrive Rinseng compound,and 120 patients will be as blank countrol group.Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma

Description:

GLSE compound、Maitake mushroom extract compound and Rinseng compound have different mechanism on enhancing immunity.This clinicaltrial compare them the immune effect in the progress of treating lung neoplasms and breast carcinoma.Within the 42 days,we will abide by the plan to evaluate the immunity enhancement by monitoring mmune effector molecules.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: February 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• lung cancer and breast cancer patients confirmed by surgery pathology;

• ECOG physical stamina score of 0~3 points;

• Expected lifetime > 3 months;

• Need to receive radiation and chemotherapy;

• Heart, liver and kidney function and blood picture is normal,WBC=4×109/L, neutrophil count= 2 x 109 / L,platelet count=100×109/L, hemoglobin=100 g/L;

• To follow-up, good adherence

Exclusion Criteria:

• Allergic to text drug;

• Pregnancy or lactation women;

• Suffering from mental illness of not easy to control,

• Have serious mental or cognitive dysfunction;

• Can not comply with the experimental scheme or can't cooperate with the follow-up;

• The patients who are unfavorable to the subject.

Related Conditions & MeSH terms

• Breast Neoplasms
• Lung Neoplasms
• Neoplasms

Intervention

Drug:
• GLSE compound

• Maitake mushroom extract compound

• Ginseng compound

Locations

Country	Name	City	State
China	PLA general hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T-lymphocyte cell subsets	T-lymphocyte cell subsets contains CD3+?CD4+?CD8+?CD28-?CD28+?CD4+CD25+?HLADR+?HLADR-,measured these cells concentration level	three mouths