Condition category
Cancer
Date applied
03/01/2016
Date assigned
26/01/2016
Last edited
02/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

02/02/2016: Internal review