Plain English Summary
Background and study aims
Intractable cancer pain (that is pain that is resistant to the effects of painkillers) is a difficult medical problem. Intrathecal analgesia (that is, painkiller injected into the spinal cord) has emerged as a key therapeutic option for pain relief for patients for which other treatment avenues have not worked as well as patients on high doses of analgesia (painkiller) suffering from unacceptable side effects. Hydromorphone, is a opiod drug with effects similar to that of morphine, but is more potent and acts more quickly due to its greater lipophilic properties (that is, it is more able to dissolve in lipids, or fats). But the comparison between hydromorphone and morphine in how well they work (efficacy), safety, and pharmacoeconomics analysis research (that is, comparing the value of one drug compared to another) is rare in China. The aims of this study was to observe the effects, security and pharmacoeconomics of morphine and hydromorphone in the treatment of intractable cancer pain.
Who can participate?
Adults with cancer suffering from intractable cancer pain
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given hydromorphone via a intrathecal catheter. Those in group 2 are given morphine via a intrathecal catheter. 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 immediate direct benefit to those taking part is better pain management and a free intrathecal drug delivery system (IDDs). After treatment, patients’ quality of life may improve. The main risk of this study is surgical complications from inserting the intrathecal catheter including bleeding, neurological injury, infection, cerebrospinal fluid (CSF) leakage and shredded catheters.
Where is the study run from?
Pain Management Department, Xinhua Hospital (affiliated to Shanghai Jiaotong University, School of Medicine)
When is the study starting and how long is it expected to run for?
December 2015 to December 2016
Who is funding the study?
Chinese association for the study of pain, the minimally invasive interventional group
Who is the main contact?
Professor Ke MA
marke72@163.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Ke MA
ORCID ID
http://orcid.org/0000-0002-5603-9321
Contact details
Pain Management Centre
Xinhua Hospital (affiliated with Shanghai Jiaotong University
School of Medicine)
No 1665
Kongjiang Road
Yangpu District
Shanghai
2000092
China
+86 13651663779
marke72@163.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The efficacy, safety and cost-effectiveness analysis of morphine and hydromorphone in intrathecal drug deliver system for intractable cancer pain：a multicenter, randomized single-blind, controlled study.
Acronym
Study hypothesis
1. Morphine and hydromorphone are effective and safe when administered using the intrathecal drug delivery system for intractable cancer pain patients.
2. Morphine and hydromorphone administered using the intrathecal drug delivery system can improve the quality of life and reduce the oral pain-related drugs dosage of cancer pain patients.
Ethics approval
Xinhua hospital Ethics Committee Affiliated to Shanghai Jiaotong University School of Medicine, 08/09/2015, ref: XHEC-C -2015-018-2
Study design
Muiticenter single-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 contact details to request a participant information sheet
Condition
Cancer pain
Intervention
An intrathecal catheter is placed at the L4/5 or L3/4 level and the catheter is passed under fluoroscopic guidance to the T10 or T11 vertebral level. Then, a tunneled subcutaneous catheter plus a subcutaneous port, with an external infusion pump system were implanted.
240 patients with cancer pain were randomized and assigned into 2 equal groups:
1. Hydromorphone group (n = 120)
2. Morphine group (n = 120)
The duration of follow-up is 3 months post-treatment.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Pain after treatment, measured using the visual analogue score (VAS) every day during 3 months after treatment
2. Drug cost-effectiveness at 1, 2 and 3 months after treatment
Secondary outcome measures
1. The frequency, duration and degree of the flare pain everyday during 3 months after treatment
2. Intensity of anxiety experienced by patient. measured using the PHQ - 9 evaluation scale at 1, 2 and 3months after treatment
3. Intensity of depression experienced by patient, measured by the GAD - 7 anxiety screening scale) at 1, 2 and 3months after treatment
4. Quality of life measured by the quality of life score (SF - 36) at 1, 2 and 3 months after treatment
Overall trial start date
01/12/2015
Overall trial end date
31/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Cancer pain
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240
Participant exclusion criteria
1. Researchers think that there is any reason can't include
2. IDDS procedure contraindications
3. Uncooperative and unable to finish the self evaluation (PHQ - 9, GAD - 7 and SF-36)
4. Spinal deformity, intolerance to operation
5. The central infection, severe systemic infection
6. The blood coagulation dysfunction; severe liver and kidney dysfunction
7. Patient who has a history of drug abuse
Recruitment start date
01/12/2015
Recruitment end date
30/12/2016
Locations
Countries of recruitment
China
Trial participating centre
Pain Management Department, Xinhua Hospital affiliated to Medical School of Shanghai Jiaotong University
No 1995 Kongjiang Road
Shanghai
200092
China
Trial participating centre
Pain Medicine Center, Nanjing Jinling Hospital,
No.305 Zhongshan East Road
Nanjing
210002
China
Trial participating centre
Tiantan Hospital, Pain Department
No 6, West Tiantan Road
Dongcheng District
Beijing
100050
China
Trial participating centre
Xijing Hospital, Pain Management Department
No 127, West Changle Road
Xi'an
710032
China
Trial participating centre
The First Affiliated Hospital, China Medical University
Department of Pain Medicine
No 155，North Nanjing Road
Heping District
Shenyang
110001
China
Trial participating centre
The First Hospital affiliated to Medical School of Zhejiang University
Pain Management Department
NO 79，Qingchun Road
Hangzhou
310003
China
Trial participating centre
Gulou Hospital
Pain Management Department
No 321, Zhongshan Road
Nanjing
210008
China
Trial participating centre
The People's Hospital of Qinghai Province
Pain Management Department
No.2, Gonghe Road
Xi‘ning
810007
China
Trial participating centre
The First Hospital affiliated to Chongqing Medical College
No 1, Youyi Road
Yuan jiaguang, Yu Zhong Distric
Chongqing
400016
China
Trial participating centre
The 2nd affiliated Hospital of Kunming Medical College
Pain Management Department
No 1, Dian Mian Road.
Kunming
650000
China
Trial participating centre
The Tenth Hospital affiliated to Tongji University
Department of Anesthesiology
No 301,Yanchang Road
Shanghai
200072
China
Trial participating centre
Tumor Hospital of Hennan province
Department of Pain Medicine
No 127 Dongming Road
Zhengzhou
450008
China
Sponsor information
Organisation
Chinese association for the study of pain, the minimally invasive interventional group
Sponsor details
No 6
The West Tiantan Road
Chongwen district
Beijing
100050
China
+86 13361879260
marke72@sjtu.edu.cn
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Chinese association for the study of pain, the minimally invasive interventional group
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The clinical trial will be finished at Mar 2017, and the paper will be finished and contributed to an appropriate journal in Jun 2017.
Intention to publish date
30/06/2017
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list