None listed
Conditions
Brief summary
Capecitabine (Xeloda) is an oral chemotherapy agent that has shown to be effective in breast and gastrointestinal cancers. Patients receiving Xeloda tend to experience less severe side effects such as diarrhoea, mouth sores, nausea , hair loss and reduced white blood counts. Hand and foot syndrome (HFS) is a common complication for patients receiving Xeloda. Although it is not a life-threatening complication, it can be disabling in severe cases and affects the treatment course due to the need for dose interuption or reducation. Some previous research has suggested that the addition of Pydidoxine (vitamin B) to the chemotherapy may reduce the incidence and severity of HFS. The study is a double blind study comparing the administration of oral 200mg pryidoxine with an oral placebo for 24 weeks. Neither the patient of the Doctor will know what treatment (active drug or placebo) the patient will be allocated.
Interventions
The specific pathophysiologic mechanism of HFS is unclear. The clinical features of HFS are characteristic and evolve in stages. Most patients have their first (92.9%) or most severe (67.9%) episode of HFS within the first two cycles of treatment.11
Initially, symptoms are very mild with no obvious changes to the hands and feet. Patients may experience a prodrome of about 3 to 5 days, which consists of vague paraesthesias and tingling of the extremities, or painless swelling or erythema (grade
The specific pathophysiologic mechanism of HFS is unclear. The clinical features of HFS are characteristic and evolve in stages. Most patients have their first (92.9%) or most severe (67.9%) episode of HFS within the first two cycles of treatment.11 Initially, symptoms are very mild with no obvious changes to the hands and feet. Patients may experience a prodrome of about 3 to 5 days, which consists of vague paraesthesias and tingling of the extremities, or painless swelling or erythema (grade 1). If the drug is continued, the syndrome progresses with painful erythema and swelling (grade 2). It may further progress to fissuring, ulceration and desquamation involving the hands and feet, leading to extreme pain when grasping objects or walking (grade 3).11 Resolution of HFS occurs upon discontinuation of capecitabine. Histologically, the condition is marked by hyperkeratosis associated with an inflammatory cell infiltrate and an increase in vascularity of the dermis. The treatment group will receive oral Pyridoxine 200gm daily for 24 weeks.
Sponsors
Dr Chris Karapetis
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Commencement of capecitabine at a dose of 800mg/m2 BD every 2 out of 3 weeks either as single agent or combination therapySigned informed consent. Life expectancy greater than 12 weeksConcommitant radiotherapy or steroids permitted
Exclusion criteria
Prior capecitabine chemotherapy over the past 30 daysInability to provide informed consentConcommitant administration of drugs that cause HFS eg docetaxel, liposomal doxorubicinConsumption of pyridoxine-containing preparationsAnticipated inability to follow up patient for side effects of chemotherapy.
Outcome results
None listed