A randomised placebo-controlled study evaluating the role of pyridoxine in controlling capecitabine-induced hand-foot syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN82842634

Enrollment

270

Registered

2006-02-06

Start date

2004-06-01

Completion date

Unknown

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand-foot syndrome in patients with advanced colorectal or breast cancer Cancer Hand-foot syndrome in patients with advanced colorectal or breast cancer

Interventions

1. Double-blind randomised controlled trial of pyridoxine versus placebo 2. Sweat test 3. Additional 20 ml bloods 4. Urine (20 ml) at up to three clinic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with advanced colorectal or breast carcinoma receiving single agent capecitabine chemotherapy 2. No other concomitant chemotherapy or immunotherapy 3. Life expectancy more than 12 weeks 4. Performance status zero, one or two (Eastern Cooperative Oncology Group [ECOG] performance scale) 5. Aged over 18 years 6. Laboratory parameters: a. Haemoglobin B more than 10 g/dl b. Platelets more than 100,000 mm^3 c. White Cell Count (WCC) more than 3.0 x 10^9/l d. Absolute Neutrophil Count (ANC) more than 1.5 x 10^9/l e. Bilirubin less than 1.3 times Upper Limit of Normal (ULN) f. Alkaline phosphatase less than five times ULN g. Transaminases less than five times ULN h. Creatinine less than 1.5 times ULN 7. Written informed consent provided by the patient 8. Radiotherapy during the study period is allowed 9. Women of child-bearing potential must have a negative pregnancy test prior to study entry and be using adequate contraception, which must be continued for three months after the study

Exclusion criteria

Exclusion criteria: 1. Any concomintant chemotherapy or immunotherapy 2. Any previous investigational agent within the last six weeks 3. Any other serious or uncontrolled illness, which in the opinion of the investigator, makes it undesirable for the patient to enter the trial 4. Any medical or psychiatric condition which would influence the ability to provide informed consent

Design outcomes

Primary

Measure	Time frame
To determine whether pyridoxine can reduce the need for chemotherapy dose modifications (dose delay and dose reductions).	—

Secondary

Measure	Time frame
1. Incidence of capecitabine-induced HFS 2. Overall toxicity 3. Quality of life 4. Response to chemotherapy 5. Progression-free survival 6. Measurement of biomarkers which might predict the occurrence of HFS	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026