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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.
Artículo en Inglés | WPRIM | ID: wpr-922123
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 11 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).
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Texto completo: Disponible Índice: WPRIM (Pacífico Occidental) Asunto principal: Calidad de Vida / Vómitos / Ensayos Clínicos Controlados Aleatorios como Asunto / Método Doble Ciego / Estudios Multicéntricos como Asunto / Resultado del Tratamiento / Quimioterapia Adyuvante / Neoplasias del Colon / Náusea Tipo de estudio: Ensayo Clínico Controlado / Guía de Práctica Clínica Límite: Humanos Idioma: Inglés Revista: Chinese journal of integrative medicine Año: 2021 Tipo del documento: Artículo

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Texto completo: Disponible Índice: WPRIM (Pacífico Occidental) Asunto principal: Calidad de Vida / Vómitos / Ensayos Clínicos Controlados Aleatorios como Asunto / Método Doble Ciego / Estudios Multicéntricos como Asunto / Resultado del Tratamiento / Quimioterapia Adyuvante / Neoplasias del Colon / Náusea Tipo de estudio: Ensayo Clínico Controlado / Guía de Práctica Clínica Límite: Humanos Idioma: Inglés Revista: Chinese journal of integrative medicine Año: 2021 Tipo del documento: Artículo