Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001162808
Ethics application status
Approved
Date submitted
31/10/2012
Date registered
1/11/2012
Date last updated
28/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating methods of reducing cancer recurrence by changing tissue drainage systems at the time of operation.
Scientific title
In patients with cervical and prostate cancer, does a patient’s normal lower limb lymphatic flow rate slow after the introduction of a lower limb sympathetic blockade via a spinal anaesthetic?
Secondary ID [1] 281480 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical cancer 287740 0
Prostate cancer 299680 0
Condition category
Condition code
Cancer 288082 288082 0 0
Cervical (cervix)
Anaesthesiology 288083 288083 0 0
Anaesthetics
Cancer 299617 299617 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An assessment of the speed of a participant’s lymphatic flow rates is made using lymphoscintigraphy - a baseline measurement is established. Two weeks later, a spinal anaesthetic is performed (the exposure). The spinal anaesthetic provides complete sympathetic blockade to the lower limbs. Immediately following the exposure, a second lymphoscintigram is performed and the results are compared.
1. Both of the lymphoscintigrams are performed over two hours. A 0.4ml bleb of colloid tracer is injected between the first and second toes. The passage of the colloid flow up the leg is followed using gamma camera imaging. The patient lies flat through this procedure. The transient discomfort of the injection is the only harm to the patient. We have received ethics approval for the use of the (harmless) low dose radio-isotope injection.
2. The spinal anaesthestic is routinely performed for these patients as they are receiving brachytherapy that requires applicator insertion into the cervix or prostate. The lymphoscintigraphy is being performed after the procedure has been completed, but with the spinal anaesthetic still active. A typical spinal anaesthetic dose is 12miligrams of intrathecal bupivicaine and 20micrograms of intrathecal Fentanyl.
Intervention code [1] 285986 0
Not applicable
Comparator / control treatment
The study design is such that the participants act as their own controls. A measurement is made on the same participant before and after the exposure. The results are then compared.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288287 0
Ratio of groin sentinel node tracer activity to injection site activity as assessed by lymphoscintigraphy under control and exposure conditions.
Timepoint [1] 288287 0
At 60 and 120 minutes after injection of colloid tracer.
Secondary outcome [1] 299778 0
Nil
Timepoint [1] 299778 0
Nil

Eligibility
Key inclusion criteria
- Patients presenting for brachytherapy for cervical or prostatic carcinoma at Peter MacCallum Cancer Centre;
- Patients requiring Magnetic Resonance Imaging after first treatment (and hence requiring a spinal anaesthetic).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Abnormal pre-existing lymph flow or sympathetic tone including: Complex Regional Pain Syndrome (CRPS), lymphoedema of any cause, surgery or trauma to the lower extremities and any cutaneous or sub cutaneous inflammation in the lower extremities;
- Obesity as defined BMI >30kg/m2;
- Diabetes Mellitus (type 1 and 2);
- Patients currently on beta blockers or alpha antagonists;
- Clinically or otherwise (Ultrasound) demonstrated lymphadenopathy;
- Absent motor block prior to performing second lymphoscintigram;
- Acute use of Non-Steroidal Anti-Inflammatory Drugs (last 24hours) preceding lymphoscintigram.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Due to some patient discomfort in study participation, and that a clear demonstration of proof-of-concept was achieved, a submission was made and granted to stop the trial prior to planned total recruitment.
Date of first participant enrolment
Anticipated
30/10/2012
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
15/12/2014
Date of last data collection
Anticipated
Actual
15/12/2014
Sample size
Target
16
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
ACT,VIC

Funding & Sponsors
Funding source category [1] 286250 0
Other Collaborative groups
Name [1] 286250 0
Australian and New Zealand College of Anaesthetists
Country [1] 286250 0
Australia
Funding source category [2] 286251 0
Other Collaborative groups
Name [2] 286251 0
Peter MacCallum Cancer Centre
Country [2] 286251 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Peter MacCallum Cancer Centre
Department of Surgical Oncology
St. Andrews Place
East Melbourne
Victoria, 8006
Australia
Country
Australia
Secondary sponsor category [1] 285053 0
None
Name [1] 285053 0
nil
Address [1] 285053 0
nil
Country [1] 285053 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288328 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 288328 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne
Victoria, 8006
Australia
Ethics committee country [1] 288328 0
Australia
Date submitted for ethics approval [1] 288328 0
Approval date [1] 288328 0
06/07/2012
Ethics approval number [1] 288328 0
Project Number 09/15

Summary
Brief summary
The body’s lymphatics vessels have an important function and move fluid outside blood vessels through lymph glands. This role in ‘clean up’ of cell debris after surgery is very important to understand as these lymphatic channels are also mechanisms of spread of cancer cells. Lymph glands are a common site where cancer recurs after surgery. There is evidence to suggest that the movement of lymph through lymphatic channels alters under epidural/spinal anaesthesia. These sorts of anaesthesia techniques are sometimes performed at the time of surgery for pain relief; this study will consider whether they also have a role in the reduction of lymph flow at the time of surgery. Doctors may therefore be able to utilise another technique to reduce the risk of cancer recurrence after surgery.
Primary research hypothesis:
Lymphatic flow in the lower limb is reduced by sympathetic blockade (spinal anaesthesia).
Trial website
Trial related presentations / publications
Accepted for publication in Anesthesia and Analgesia
Public notes

Contacts
Principal investigator
Name 34903 0
Dr Jonathan Hiller
Address 34903 0
Peter MacCallum Cancer Centre
305 Grattan street
Melbourne, 3000
Victoria
Country 34903 0
Australia
Phone 34903 0
+61 3 8559 5000
Fax 34903 0
Email 34903 0
[email protected]
Contact person for public queries
Name 18150 0
Dr Dr Jonathan Hiller
Address 18150 0
Peter MacCallum Cancer Centre
305 Grattan street
Melbourne, 3000
Victoria
Country 18150 0
Australia
Phone 18150 0
+61 3 8559 5000
Fax 18150 0
Email 18150 0
[email protected]
Contact person for scientific queries
Name 9078 0
Dr Jonathan Hiller
Address 9078 0
Peter MacCallum Cancer Centre
305 Grattan street
Melbourne 3000
Victoria
Country 9078 0
Australia
Phone 9078 0
+61 3 8559 5000
Fax 9078 0
Email 9078 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNeuraxial Anesthesia Reduces Lymphatic Flow: Proof-of-Concept in First In-Human Study.2016https://dx.doi.org/10.1213/ANE.0000000000001562
Dimensions AIChronic stress in mice remodels lymph vasculature to promote tumour cell dissemination2016https://doi.org/10.1038/ncomms10634
N.B. These documents automatically identified may not have been verified by the study sponsor.