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

Not Applicable

Completed

• Conditions: Lung Neoplasms; Breast Neoplasms
• Interventions: Drug: Maitake mushroom extract compound; Drug: Ginseng compound; Drug: GLSE compound

• Registration Number: NCT02603016
• Lead Sponsor: Chinese PLA General Hospital

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Primary Completion: 2016-11
• Study Completion: 2017-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-11
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maitake mushroom extract compound group	Maitake mushroom extract compound	Maitake mushroom extract compound 2 tables each time by mouth,twice a day for 42 days.
Ginseng compound group	Ginseng compound	Ginseng compound 2 tables each time by mouth,twice a day for 42 days.
GLSE compound group	GLSE compound	GLSE compound 2g each time by mouth,twice a day for 42 days.

Primary Outcome Measures

Name	Time	Method
T-lymphocyte cell subsets	three mouths	T-lymphocyte cell subsets contains CD3+、CD4+、CD8+、CD28-、CD28+、CD4+CD25+、HLADR+、HLADR-,measured these cells concentration level

Trial Locations

Locations (1)

PLA general hospital; 🇨🇳 Beijing, Beijing, China