Therapeutic Effects of Traditional Chinese Medicine, Shen-Mai San in Cancer Patient Undergoing Chemotherapy or Radiotherapy

Changhua Christian Hospital60 enrolled

Overview

Using Shen-Mai-San for cancer patients undergoing chemotherapy or radiotherapy could help these people improve the quality of life.

Shen-Mai-San could improve fatigue, general weakness, neutropenia for patients under going chemotherapy or radiotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Cancer Patients Undergoing Chemotherapy or Radiotherapy

Interventions

Shen-Mai SanDRUG

Shen mai san is composed of three herb medicines, Ginseng radis, Liriope spicata, and Schizandrae fructus and was manufactured into concentrated herbal extract and packed with 0.5g per capsule and labeled by Sun-Ten pharmaceutical company in Taiwan with good manufacturing practice (GMP).

StarchDRUG

It was packed in granules with 0.5gm starch. Patients took eight granules three times per day for four weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Postoperative patients with histologically confirmed cancer within 3 years and undergoing chemotherapy or radiotherapy * age above 18 years old * signed informed consent * ability to read Chinese, ability for oral intake. Exclusion Criteria: * being pregnancy * on breast feeding * completed chemotherapy or radiotherapy * brain metastasis with Eastern Cooperative Oncology Group (ECOG) performance status of two to four * delusion or hallucination * acute infection * received medications for other clinical trials.

Locations (1)

Changhua Christian Hospital

Changhua, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Change from baseline in EORTC QOL-C30 at four weeks

Time frame: baseline and four weeks

Secondary Outcomes

Change from baseline in BUN, Creatinine, GOT, GPT at four weeks

monitor the liver function and renal function

Time frame: baseline and four weeks

Change from baseline in Heart rate variability at four weeks

Time frame: baseline and four weeks

Central Contacts

Chia Yun Chen, MD

CONTACT

+886-47238595 137877@cch.org.tw

Data from ClinicalTrials.gov

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