Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial / 中国结合医学杂志
Chinese journal of integrative medicine
; (12): 891-895, 2021.
Article
em En
| WPRIM
| ID: wpr-922123
Biblioteca responsável:
WPRO
ABSTRACT
BACKGROUND@#The side effects of chemotherapy-induced nausea and vomiting (CINV) and myelosuppression reduce the cancer patients' adherence to chemotherapy. Many Chinese patients choose Chinese medicine (CM) during chemotherapy to reduce side effects; however, the evidence is lacking. The efficacy of a CM herbal treatment protocol, Jianpi Bushen Sequential Formula (, JBSF) will be evaluated on chemotherapy completion rate among patients with colon cancer.@*METHODS@#A multi-center double-blind randomized controlled trial (RCT) will be conducted on 400 patients with colon cancer who will receive 8 cycles of adjuvant chemotherapy with oxaliplatin and capecitabine (CAPEOX). Patients will be randomized 1:1 to receive the JBSF or placebo formula. The primary outcome is the overall chemotherapy completion rate. The secondary outcomes include individual chemotherapy completion rate, 4-cycle completion rate of chemotherapy, time to treatment failure, relative dose intensity and treatment toxicity. Follow-up visits will be scheduled before every and after last chemotherapy.@*DISCUSSION@#This study will provide evidence on whether JBSF can improve the chemotherapy completion rate and reduce side effects among patients with colon cancer. (Trial registration: ClinicalTrials.gov, No. NCT03716518).
Palavras-chave
Texto completo:
1
Índice:
WPRIM
Assunto principal:
Qualidade de Vida
/
Vômito
/
Ensaios Clínicos Controlados Aleatórios como Assunto
/
Método Duplo-Cego
/
Estudos Multicêntricos como Assunto
/
Resultado do Tratamento
/
Quimioterapia Adjuvante
/
Neoplasias do Colo
/
Náusea
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Humans
Idioma:
En
Revista:
Chinese journal of integrative medicine
Ano de publicação:
2021
Tipo de documento:
Article