Clinical study of the effect of oral administration of magnesium threoninate (L-TAMS) in morphine analgesia and tolerance

Not Applicable

Completed

• Conditions: Cancer pain; Signs and Symptoms

• Registration Number: ISRCTN60931429
• Lead Sponsor: Xinhua Hospital (affiliated with Shanghai Jiaotong University School of Medicine)

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36703238/ (added 14/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-24
• Study Completion: 2019-07-31
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

1. Subjects voluntarily signed the informed consent
2. Patients suffering from cancer pain with treatment of morphine, aged from 18 to 80 regardless of gender
3. Survival time is expected to exceed 3 months
4. Moderate to severe pain, VAS >4 points or more, or outbreak of pain >3 times/day
5. Patients can follow the drug dose and follow-up plan
6. Patients can describe the symptoms, no serious infection, respiratory insufficiency and has the ability to cooperate
7. Non-allergic persons
8. No drug abuse or drug addiction
9. Non-lactating, pregnant women. Subjects who did not have a pregnancy plan within 1 month after the test
10. Patients did not participate in a drug test within 3 months before this test (including the test drug)

Exclusion Criteria

1. Researchers think that there is any reason they can't be included
2. In poor situation, severe systemic infection or respiratory dysfunction and uncooperative
3. Suffering from severe respiratory system, cardiovascular system diseases, liver and kidney dysfunction, cancer
4. Patients who are allergic to magnesium threonate (L-TAMS)
5. Patient who has a history of drug abuse
6. Breastfeeding, gestational women or subjects who do not have a pregnancy plan within 1 month after the test
7. Patients who participated in a drug trial within 3 months before this trial
8. Patients does not meet the inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pain, measured using the visual analogue score (VAS) every day during the treatment. The frequency and intensity of the pain outbreak every day during the treatment<br>2. The dosage of morphine per day during the treatment

Secondary Outcome Measures

Name	Time	Method
1. Intensity of anxiety, measured using the PHQ-9 evaluation scale every day during the treatment<br>2. Intensity of depression, measured by the GAD-7 anxiety screening scale) every day during the treatment<br>3. Quality of life, measured by the quality of life score (QOL) every day during the treatment