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Study for the Therapeutic Effect and Mechanism of Strengthening the Spleen and Harmonizing the Stomach Therapy in Improving the Quality of Life during Chemotherapy

Study for the Therapeutic Effect and Mechanism of Strengthening the Spleen and Harmonizing the Stomach Therapy in Improving the Quality of Life during Chemotherapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021492
Enrollment
Unknown
Registered
2019-02-23
Start date
2019-02-23
Completion date
Unknown
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Interventions

A:The first and third cycles were treated with Chinese herbal medicine from the day before chemotherapy to the sixth day, and the second and fourth cycles were treated with placebo from the day before
B:The first and third cycles were treated with placebo from the day before chemotherapy to the sixth day, and the second and fourth cycles were treated with traditional Chinese medicine from the day b

Sponsors

Xiyuan Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients with colorectal cancer with definite pathological diagnosis; (2) Those who are receiving XELOX regimen as adjuvant chemotherapy; (3) aged 18 to 80 years male and female; (4) At least 4 cycles of XELOX regimen chemotherapy were received after admission into the group; (5) Sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) History of previous or combined malignant tumors, with the exception of cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; (2) Complicated with severe complications of heart, liver and kidney; (3) Patients with intestinal obstruction can not take decoction, need intravenous high-energy nutrition; suffer from malabsorption syndrome or other diseases affecting gastrointestinal absorption, or active peptic ulcer disease; (4) Any unstable situation or situation that may endanger the safety of patients and their compliance with the study; (5) Researchers estimate that the survival time is less than half a year according to the clinical treatment experience and patients'condition; (6) Researchers judged subjects with poor compliance or who could not cooperate in completing the study.

Design outcomes

Primary

MeasureTime frame
NCI-CTC;

Secondary

MeasureTime frame
MDASI;Intestinal flora analysis;patient diary;

Countries

China

Contacts

Public ContactYufei Yang

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

yyf93@vip.sina.com+86 13701366913

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026