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Moxibustion combined with herbs for the prophylactic and therapeutic use of chemotherapy-induced leukopenia in breast cancer: a randomized controlled trial

Moxibustion combined with herbs for the prophylactic and therapeutic use of chemotherapy-induced leukopenia in breast cancer: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16009557
Enrollment
Unknown
Registered
2016-10-23
Start date
2017-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Breast Cancer

Interventions

control group:no
MP group:moxibustion plus placebo
MH group:moxibustion plus herbs

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. All patients were meet the pattern identification criteria of TCM and diagnostic criteria of western medicine; 2. Patients must be female; 3. Aged from 18 to 80; 4. Pathological investigations confirmed a primary invasive breast cancer; 5. According to the pathological results and the physical condition, all patients were required to make standard chemotherapy plan with breast cancer guidelines of CBCSG (version 2015); 6. Patients who are expected to complete chemotherapy and agree to receive chemotherapy; 7. Leucocyte count and absolute neutrophils count must be above the upper limit of normal value before chemotherapy; 8. Be willing to participate in clinical trials and be able to cooperate with regular follow-up; 9. All patients must have signed and dated an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previous history of systemic chemotherapy or radiotherapy 2. Severe liver and kidney dysfunction (AST/SGOT or ALT/AGPT is > 2.5 times of the ULN, and Serum Cr is =150umol/L); 3. Severe heart dysfunction other organ failure; 4. Any previous or concurrent primary malignancy; 5. Women in pregnant and lactating period (serum ß-HCG testing); 6. Participating in other clinical trials within 3 months; 7. In any reason that cannot cooperate with the study, such as language understanding, unable to refer to the research center, etc; 8. Other conditions or diseases that may be excluded from the study that may result in significant risk or confusion in the study.

Design outcomes

Primary

MeasureTime frame
Prophylactic function: delaying the occurrence time, reducing the reduction degree, and cutting down the serious adverse events (SAEs);Therapeutic function: recovering the Level I decreased white blood cells and/or absolute neutrophil counts and decreasing the number of administration of rhG-CSF;

Secondary

MeasureTime frame
To observe the adverse events of moxibustion combined with herbs;To observe the quality of life during chemotherapy;To follow the 3-year disease free survival and overall survival;

Contacts

Public ContactXiaohong Xue

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM

xiaohong_xue0702@163.com+86 18930568130

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026