Condition category
Signs and Symptoms
Date applied
11/01/2018
Date assigned
24/01/2018
Last edited
22/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ke Ma

ORCID ID

Contact details

No 1665 Kongjiang Road Yangpu District
Shanghai
200092
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

XINHUA2018-01

Study information

Scientific title

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

Acronym

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

Xinhua Hospital Ethics Committee Affiliated to Shanghai Jiaotong University School of Medicine, 26/12/2017, ref: XHEC-C -2017-106

Study design

Single-center double-blinded randomized controlled clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Cancer pain

Intervention

98 participants are randomly allocated to two groups. Those in group 1 (n=49) are given magnesium threonate (L-TAMS) 1.5g/day for 12 weeks. Those in group 2 (n=49) are given placebo 1.5g/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

Phase

Not Applicable

Drug names

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 trial start date

01/02/2018

Overall trial end date

31/07/2019

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

98

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

Trial participating centre

Pain Management Centre, Xinhua Hospital (affiliated with Shanghai Jiaotong University School of Medicine)
200092
China

Sponsor information

Organisation

Xinhua Hospital (affiliated with Shanghai Jiaotong University School of Medicine)

Sponsor details

No 1665 Kongjiang Road Yangpu District
Shanghai
200092
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Xinhua Hospital (affiliated with Shanghai Jiaotong University School of Medicine)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes