None listed
Conditions
Brief summary
The aim of this study is to evaluate the effect of Vitamin C in patients with cancer pain. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have pain related to cancer or its treatment, for which you are receiving regular daily opioids (painkillers). Trial details All participants in this trial will take two 1 gram tablets of vitamin C daily for 3 consecutive days in addition to your normal pain medications. You will be asked to complete some forms regarding pain medication use and pain relief over this 3 day period. This will enable us to determine whether there is any benefit in pain relief and/or your need to take extra or breakthrough pain medications.
Interventions
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.
Sponsors
Mater Health Services
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed