Skip to content

A prospective, double-blind, randomized, placebo-controlled study of Tianchan Capsule combined with Oxycontin in the treatment of pain in advanced colorectal cancer

Research and Evaluation special project of China Association of Traditional Chinese Medicine

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063670
Enrollment
Unknown
Registered
2022-09-14
Start date
2022-09-04
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Cancer pain in advanced colorectal cancer

Interventions

Experimental group:Xenopus capsule + Oxycontin
The control group:Placebo + OxyContin

Sponsors

Cancer Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Patients with unresectable advanced metastatic colorectal cancer pain who received systemic chemotherapy, with or without targeted agents (cetuximab or bevacizumab or trastuzumab); (2) Patients with locally advanced colorectal cancer pain who received neoadjuvant chemotherapy with or without targeted agents (cetuximab or bevacizumab or trastuzumab) and the remaining neoadjuvant therapy course =30 days at the time of enrollment; (3) Moderate to severe cancer pain, NRS score > 3; (4) The syndrome differentiation of TCM belongs to the syndrome of qi stagnation and blood stasis; (5) KPS=60 points.

Exclusion criteria

Exclusion criteria: (1) Expected survival < 3 months; (2) non-cancerous pain, such as pain associated with tumor emergency and other neuropathic pain associated with tumor; (3) people who are allergic to the active ingredients in Xenopus capsule; (4) severe liver, heart and kidney dysfunction; (5) Patients with previous severe antitumor drug-related toxicity; (6) Patients with abnormal respiratory function, craniocerebral related history and hypotension; (7) Those who cannot cooperate with the treatment plan and have difficulty in making accurate judgments about their own pain and general conditions; (8) Patients who took proprietary Chinese medicine and Traditional Chinese medicine decoction related to tumor treatment within 30 days before enrollment; (9) patients who had received radiotherapy within 30 days before enrollment; (10) Patients who received radiotherapy plan within 14 days after enrollment.

Design outcomes

Primary

MeasureTime frame
Pain relief rate;

Secondary

MeasureTime frame
TCM syndrome score;

Countries

China

Contacts

Public ContactFengli

Cancer Hospital, Chinese Academy of Medical Sciences

fengli663@126.com18618147576

Outcome results

None listed

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