Vitamin C in cancer pai
- Conditions
- Alternative and Complementary Medicine - Other alternative and complementary medicineCancer painCancer - Any cancer
- Registration Number
- ACTRN12613000469718
- Lead Sponsor
- Mater Health Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 43
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
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[Day 1, Day 2, Day 3]
- Secondary Outcome Measures
Name Time Method Brief Pain Inventory - average pain score[Baseline, 24hr, 48hr, 72hr];Brief Pain Inventory - worst pain score[Baseline, 24hr, 48hr, 72hr];Brief Pain Inventory - best pain score[Baseline, 24hr, 48hr, 72hr];Brief Pain Inventory - pain relief score[Baseline, 24hr, 48hr, 72hr]