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Shenmai injection for cancer-related fatigue in advanced non-small-cell lung cancer patients undergoing chemotherapy: study protocol for a randomized controlled trial

Shenmai injection for cancer-related fatigue in advanced non-small-cell lung cancer patients undergoing chemotherapy: study protocol for a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17013737
Enrollment
Unknown
Registered
2016-12-06
Start date
2017-12-25
Completion date
Unknown
Last updated
2017-12-11

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

Conditions

Cancer-related fatigue, CRF

Interventions

Experimental group:Routine treatment + Shenmai injection (100ml ivd,qd, d1-5)

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. with histologically or cytologically confirmed NSCLC; 2. clinical stage IIIB, IIIC or IV; 3. Clinical confirmed cancer related fatigue; 4. TCM syndrome is deficiency of qi; 5. scores of fatigue =4 within 24h; 6. Aged from 18 to 75-years-old; 7. Eastern Cooperative Oncology Group (ECOG) performance status score 1 to 2; 8. Adequate organ function; 9. Accepted chemotherapy (AP, TP, DP or GP regimen); 10. Hemoglobin is higher than 90g/L; 11. Normal thinking and ability to read and write in Chinese; 12. Good compliance and sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with central nervous system metastasis that has not yet been treated with surgery and/or radiation; 2. Active double cancer; 3. A history of mental disease (anxiety or severe depression) or cognitive dysfunction; 4. Any evidence of active tuberculosis and other serious infectious diseases; 5. Received previous radiotherapy or targeted drug therapy within one month; 6. Received APO and oral or intravenous proprietary Chinese medicine reinforcing Qi; 7. Severe hypersensitivity to shenmai injection and its components; 8. Currently pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
assessment of CRF;

Secondary

MeasureTime frame
assessment of anxiety and depression;Sleep quality assessment;life quality evaluation;

Countries

China

Contacts

Public ContactYu-Shu Zhou

Guangdong Provincial Hospital of Traditional Chinese Medicine

20387493@qq.com+86 15918452560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 23, 2026