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

NCT02603016 | Completed DMC

• 1 other identifier: PLAGHS201503601
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Neoplasms; Breast Neoplasms

Keywords

Clinical Nutrition

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

GLSE compound group

EXPERIMENTAL

GLSE compound 2g each time by mouth,twice a day for 42 days.

Drug: GLSE compound

Maitake mushroom extract compound group

EXPERIMENTAL

Maitake mushroom extract compound 2 tables each time by mouth,twice a day for 42 days.

Drug: Maitake mushroom extract compound

Ginseng compound group

EXPERIMENTAL

Ginseng compound 2 tables each time by mouth,twice a day for 42 days.

Drug: Ginseng compound

blank control group

NO INTERVENTION

Take nothing.

Interventions

GLSE compound DRUG

GLSE compound group

Maitake mushroom extract compound DRUG

Maitake mushroom extract compound group

Ginseng compound DRUG

Ginseng compound group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

PLA general hospital

Beijing, Beijing Municipality, 1000853, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shunchang Jiao, Doctor

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 11, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: February 1, 2017
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

CN (1)