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

Changhua Christian Medical Foundation

Status: Unknown

Conditions: Cancer Patients Undergoing Chemotherapy or Radiotherapy

Treatments: Drug: Shen-Mai San; Drug: Starch

Study type: Interventional

Funder types: Other

Identifiers

NCT01580358

CCMP98 -CT-203

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Shen-Mai San

Active Comparator group

Description:

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).

Treatment:

Drug: Shen-Mai San

starch

Placebo Comparator group

Description:

Starch in the same granule as intervention group for this double-blind trial

Treatment:

Drug: Starch