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Precise clinical diagnosis and treatment plan for low tolerance of opioids and fewer adverse reactions in the treatment of cancer pain

Precise clinical diagnosis and treatment plan for low tolerance of opioids and fewer adverse reactions in the treatment of cancer pain

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037333
Enrollment
Unknown
Registered
2020-08-28
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

Cancer Pain

Interventions

control group:placebo
experimental group:Oral magnesium supplement (magnesium threonate)

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects must meet all the following conditions before entering the trial. 1) For cancer pain patients, oral morphine sulfate sustained-release tablets/ OxyContin sustained-release tablets, morphine 4 points or higher than cancer pain, or outbreak pain > 3 times/day; 3) Expected survival time is over 3 months; 4) Subjects can follow the drug dosage and visit plan;

Exclusion criteria

Exclusion criteria: Subjects must exclude all the following conditions before entering the trial. 1) The general condition is poor, unable to describe the symptoms objectively, or if there is a serious infection, respiratory insufficiency, etc., cannot actively cooperate; 2) People with severe respiratory system, cardiovascular system disease, liver and kidney dysfunction; 3) People with allergic diseases and allergic constitution; those who are allergic to magnesium threonate drugs; 4) Those who suspect or do have a history of drug abuse and drug addiction; 5) Breastfeeding and pregnant women: subjects who have a pregnancy plan within 1 month after the test (including male subjects); 6) Patients who have participated in the drug trial (including the trial drug) within 3 months before the trial; 7) The sponsor or investigator directly involved in the trial or their family members; 8) The researcher believes that there are other reasons that cannot be selected.

Design outcomes

Primary

MeasureTime frame
Incidence of opioid tolerance within three months;

Secondary

MeasureTime frame
VAS visual analogue pain score;Constipation Quality of Life Score (PAC-QOL);Bowel Function Index (BFI);Number and extent of burst pain;High-throughput DNA sequencing of intestinal flora;

Countries

China

Contacts

Public ContactKe Ma

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

marke72@163.com+86 13361879260

Outcome results

None listed

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