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Clinical efficacy and immunological study of Lulong Zaisheng Decoction II in the treatment of chemotherapy-induced leukopenia of colorectal cancer

Clinical efficacy and immunological study of Lulong Zaisheng Decoction II in the treatment of chemotherapy-induced leukopenia of colorectal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074230
Enrollment
Unknown
Registered
2023-08-01
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

chemotherapy-induced leukopenia of colorectal cancer

Interventions

Observation group:Use Lulong Zaisheng Decoction II
Control group:Use simulants of Lulong Zaisheng Decoction II

Sponsors

Jiangsu Province Hospital on Integration of Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1) Patients who meet the above Western diagnostic criteria for stage II to IV colorectal cancer with reduced leukocyte I-II degree after primary treatment (adjuvant chemotherapy or first-line chemotherapy); (2) TCM clinical syndrome differentiation is Qi and blood deficiency syndrome; (3) The chemotherapy regimen used was CAPEOX; (4) Patients with stage IV recurrence and metastasis can be combined with bevacizumab or cetuximab targeted therapy according to gene detection; (5)18 years old = age <80 years old, gender unlimited, expected survival =3 months; (6) Quality of life score (Karnofsky score, KPS)=60 points; (7) Two consecutive cycles of chemotherapy could be completed after enrollment; (8) Good compliance, voluntary participation in this study, and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Those who do not meet the inclusion criteria; (2) Age <18 years old or =80 years old; (3) lactating and pregnant women; (4) leukopenia and/or platelets and/or hemoglobinia caused by non-chemotherapy factors; (5) Patients with primary blood system diseases and hematopoietic dysfunction; (6) Patients with severe heart, brain, liver, kidney and other primary diseases who cannot tolerate chemotherapy; (7) People who are allergic or allergic to the drugs in this study; (8) Mental or cognitive impairment, poor compliance, unable to cooperate with the researcher; (9) Participants in other clinical studies or taking other Chinese medicine, proprietary Chinese medicine or external treatment with Chinese medicine at the same time may affect the observers of the effect indicators of this study.

Design outcomes

Primary

MeasureTime frame
Peripheral white blood cell count;the incidence of grade III to IV leukopenia;

Secondary

MeasureTime frame
the incidence of grade III to IV N, PLT and Hb in the two groups;Peripheral blood T lymphocyte subsets;Antibiotic use rate, chemotherapy completion rate;Changes of peripheral blood immune and intestinal microbiome before and after treatment;Changes of TCM clinical syndrome score; Quality of life efficacy evaluation criteria;Bone marrow hematopoietic function was evaluated by magnetic resonance imaging;

Countries

China

Contacts

Public ContactFang Zhijun

Jiangsu Province Hospital on Integration of Chinese and Western Medicine

jsatcm@126.com+86 133 7201 8676

Outcome results

None listed

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