A multicenter randomized controlled trial of "Yiqi Yangying" formulation for post-operation patients with gastric carcinoma and colonic cancer receiving combination chemotherapy

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2009
INTERVENTION: Group B:FOLFOX4 course will be used: 85 mg/m2 OXA ;Group A:Orally giving "Yiqi yangyin" granul from one week before the chemotherapy to the participants. 100ml water solving one bag of granul, three times a day, totally 6 weeks, to the second week after two weeks of the chemotherapy. The combine chemotherapy course is same as control group. ; CONDITION: Gastric carcinoma and colonic cancer PRIMARY OUTCOME: Quality of life;Mortality;Disease free survival;Concentration of CD3+, CD4+, CD4+/ CD8+, NK cell, Immuknow, IL‐2, INF‐r; SECONDARY OUTCOME: Rate of chemetherapy;Assessment of physical strenth; INCLUSION CRITERIA: 1. patients with II and III stages (according to NCCN guideline 2008) gastric carcinoma and colonic cancer diagnosed by histopathology, accepted RO section treatment, without tumour focus; 2. Allow to accept the chemotherapy; 3. Aged 18 to 75; 4. KPS >=70; 5. Expected survival >=6 months; 6. Normal presentation of Blood cell count, liver function, renal function and ECG; 7. No any other tumour history, except skin cancer and cervical carcinoma; 8. Not used other anti‐tumour drugs and the drugs can influence boold cell, immun function, include "Buyi" TCMs; 9. Signed consent form.
Epistemonikos ID: 26b2e2bb67e7c63fdf2e579debc40d2741665eb0
First added on: Aug 22, 2024