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Trial registered on ANZCTR


Registration number
ACTRN12613000469718
Ethics application status
Approved
Date submitted
24/04/2013
Date registered
24/04/2013
Date last updated
11/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin C in cancer pain
Scientific title
An open label trial of oral Vitamin C as an opioid sparer in patients with chronic pain secondary to cancer
Secondary ID [1] 282393 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer pain 288974 0
Condition category
Condition code
Cancer 289312 289312 0 0
Any cancer
Alternative and Complementary Medicine 289313 289313 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive 1 gm of oral Vitamin C twice daily over 3 days (total daily dose of 2 gm Vitamin C). Inpatients will have the medication administered by the trial nurse that is supplied by pharmacy. Outpatients will have daily phone calls by the research nurse to ensure compliance with drug taking.
Intervention code [1] 287026 0
Treatment: Drugs
Comparator / control treatment
Open label trial, so no control used.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289422 0
Total daily opioid use including breakthrough doses. Collected using daily patient diary and medication chart if an inpatient and oral morphine equivalent dose calculator used to give total dose.
Timepoint [1] 289422 0
Day 1, Day 2, Day 3
Secondary outcome [1] 302442 0
Brief Pain Inventory - average pain score
Timepoint [1] 302442 0
Baseline, 24hr, 48hr, 72hr
Secondary outcome [2] 302443 0
Brief Pain Inventory - worst pain score
Timepoint [2] 302443 0
Baseline, 24hr, 48hr, 72hr
Secondary outcome [3] 302444 0
Brief Pain Inventory - best pain score
Timepoint [3] 302444 0
Baseline, 24hr, 48hr, 72hr
Secondary outcome [4] 302445 0
Brief Pain Inventory - pain relief score
Timepoint [4] 302445 0
Baseline, 24hr, 48hr, 72hr

Eligibility
Key inclusion criteria
Are age >18 years
Have pain related to cancer or its treatment
Are receiving regular daily opioids plus greater than or equal to 2 breakthrough opioid doses/day
Have had prior treatment with co-analgesics appropriate to the pain classification for a minimum of 48 hours
Have a BPI average pain score of at least 3 in the previous 24 hours
If out-patients, are able to keep an accurate record of all analgesia taken
Have no plan to increase baseline opioid dose or co-analgesics during the study period
Are capable of completing all patient assessments and complying with the study procedures
Are able to give fully informed written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Are currently taking or have previously taken high dose of Vitamin C (>2gm/day) for chronic pain by any route of administration within 6 months of the study
Have had a prior adverse reaction to Vitamin C
Are taking amygdalin, deferoxamine, indinavir, cyanocobalamin, aluminium hydroxide, amphetamines or bortezomib
Currently receiving chemotherapy or curative intent radiotherapy, that contradicts the use of Vitamin C
Impaired renal function (creatinine clearance <60ml/min)
Documented iron-overload pathologies (hereditary hemochromatosis, thalassemia major)
Have a history of kidney stones or predisposing factors for kidney stones
Are due to receive radiotherapy to a site of pain during the 3 day study period, or who have received radiotherapy at the site of pain within 2 weeks of study entry.
Have been started on chemotherapy or hormone therapy with a realistic chance of affecting pain within a month of study
Are scheduled to undergo a surgical or anaesthetic procedure likely to affect pain during the period of the study
Are pregnant or lactating. Patients at risk of pregnancy must be using effective birth control (or appropriate advice from their doctor regarding appropriate birth control)
Have participated in a clinical study of a new chemical entity within the last month prior to study entry.
Have baseline haematology and/or biochemistry screens that suggest that they are unlikely to be stable for the 3 day study period (eg markedly abnormal liver function tests, worsening renal failure, hypercalcaemia)
Have any unstable medical condition such that they would be unlikely to complete the 3 day study period

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2013
Actual
Date of last participant enrolment
Anticipated
30/11/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
43
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 949 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [2] 950 0
Mater Private Hospital - South Brisbane

Funding & Sponsors
Funding source category [1] 287172 0
Hospital
Name [1] 287172 0
Mater Health Services
Country [1] 287172 0
Australia
Primary sponsor type
Hospital
Name
Mater Health Services
Address
Raymond Terrace,
South Brisbane, QLD, 4101
Country
Australia
Secondary sponsor category [1] 285937 0
Individual
Name [1] 285937 0
Prof Janet Hardy
Address [1] 285937 0
Level 10,
Mater Adult Hospital
Raymond Terrace,
South Brisbane, QLD, 4101
Country [1] 285937 0
Australia
Other collaborator category [1] 277369 0
Individual
Name [1] 277369 0
Mr Chris McKeon
Address [1] 277369 0
Mater Adult Hospital
Raymond Terrace
South Brisbane, QLD, 4101
Country [1] 277369 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289168 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 289168 0
Ethics committee country [1] 289168 0
Australia
Date submitted for ethics approval [1] 289168 0
Approval date [1] 289168 0
11/03/2013
Ethics approval number [1] 289168 0
1939A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39538 0
Prof Janet Hardy
Address 39538 0
Mater Adult Hospital
Raymond Terrace
South Brisbane, QLD, 4101
Country 39538 0
Australia
Phone 39538 0
+61 07 31632775
Fax 39538 0
Email 39538 0
janet.hardy@mater.org.au
Contact person for public queries
Name 39539 0
Angela Tapuni
Address 39539 0
Mater Adult Hospital
Raymond Terrace
South Brisbane, QLD, 4101
Country 39539 0
Australia
Phone 39539 0
+61 07 3163 3884
Fax 39539 0
Email 39539 0
angela.tapuni@mater.org.au
Contact person for scientific queries
Name 39540 0
Angela Tapuni
Address 39540 0
Mater Adult Hospital
Raymond Terrace
South Brisbane, QLD, 4101
Country 39540 0
Australia
Phone 39540 0
+61 07 3163 3884
Fax 39540 0
Email 39540 0
angela.tapuni@mater.org.au

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
No additional documents have been identified.