Clinical study of the effect of oral administration of magnesium threoninate (L-TAMS) in morphine analgesia and tolerance
| ISRCTN | ISRCTN60931429 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60931429 |
| Secondary identifying numbers | XINHUA2018-01 |
- Submission date
- 11/01/2018
- Registration date
- 24/01/2018
- Last edited
- 14/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims
Intractable cancer pain is a difficult medical problem. The drug morphine has emerged as a key treatment option for pain relief. Morphine is the main method of controlling cancer pain, but repeated morphine use lead to tolerance and the need to increase the dose for satisfactory results. A high dose of morphine could induce constipation, respiratory depression (slow and ineffective breathing), skin itching and other side effects. The aim of this study is to assess the effectiveness of magnesium threoninate (L-TAMS) on cancer pain in patients treated with morphine, to see whether it prevents morphine tolerance.
Who can participate?
Patients aged 18 to 80 years with cancer pain being treated with morphine
What does the study involve?
Participants are randomly allocated to two groups. Those in group 1 are given magnesium threonate (L-TAMS) for 12 weeks. Those in group 2 are given a placebo (dummy drug) for 12 weeks. Both groups are also treated with morphine. The pain experienced after treatment is assessed for each patient every day for the next 3 months.
What are the possible benefits and risks of participating?
The possible benefits are that participant could have better pain relief. The main possible risk is a side effect of magnesium threoninate (L-TAMS).
Where is the study run from?
Xinhua Hospital (affiliated with Shanghai Jiaotong University School of Medicine) (China)
When is the study starting and how long is it expected to run for?
February 2018 to July 2019
Who is funding the study?
Xinhua Hospital (affiliated with Shanghai Jiaotong University School of Medicine) (China)
Who is the main contact?
Prof. Ke Ma
Contact information
Scientific
No 1665 Kongjiang Road Yangpu District
Shanghai
200092
China
Study information
| Study design | Single-center double-blinded randomized controlled clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Clinical trial of the effect of oral administration of magnesium threoninate (L-TAMS) in morphine analgesia and tolerance |
| Study hypothesis | 1. Oral administration of magnesium threoninate (L-TAMS) is safe for intractable cancer pain patients. 2. The oral administration of magnesium threoninate (L-TAMS) can improve quality of life, enhance morphine analgesia, and prevent and inhibit morphine tolerance |
| Ethics approval(s) | Xinhua Hospital Ethics Committee Affiliated to Shanghai Jiaotong University School of Medicine, 26/12/2017, ref: XHEC-C -2017-106 |
| Condition | Cancer pain |
| Intervention | 98 participants are randomly allocated to two groups. Those in group 1 (n = 49) are given magnesium threonate (L-TAMS) 1.5 g/day for 12 weeks. Those in group 2 (n = 49) are given placebo 1.5 g/day for 12 weeks. Both groups are treated with morphine. The pain experienced after treatment is assessed for each patient every day for the next 3 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Magnesium threonate (L-TAMS) |
| Primary outcome measure | 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 2. The dosage of morphine per day during the treatment |
| Secondary outcome measures | 1. Intensity of anxiety, measured using the PHQ-9 evaluation scale every day during the treatment 2. Intensity of depression, measured by the GAD-7 anxiety screening scale) every day during the treatment 3. Quality of life, measured by the quality of life score (QOL) every day during the treatment |
| Overall study start date | 01/02/2018 |
| Overall study end date | 31/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 98 |
| Total final enrolment | 116 |
| Participant 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) |
| Participant 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 |
| Recruitment start date | 01/02/2018 |
| Recruitment end date | 31/01/2019 |
Locations
Countries of recruitment
- China
Study participating centre
China
Sponsor information
Hospital/treatment centre
No 1665 Kongjiang Road Yangpu District
Shanghai
200092
China
"ROR" |
https://ror.org/04dzvks42 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The paper will be finished and submitted to a high-impact peer reviewed journal of pain, such as Pain, Pain Physician, J of Pain and so on. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/01/2023 | 14/02/2024 | Yes | No |
Editorial Notes
14/02/2024: Publication reference and total final enrolment added.
