Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring (DATACAP)

University of Oxford

Status

Completed

Conditions

Metastatic Colorectal Cancer

Metastatic Breast Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT01053104

Mobile Datacap

OCTO/Oxford (Other Identifier)

Details and patient eligibility

About

To develop a system to manage side effects and adjust chemotherapy dose such that a patient can receive their personal maximum tolerated dose.

Full description

Patients with metastatic colorectal or breast cancer will be recruited.

Metastatic Colorectal Cancer: capecitabine alone or capecitabine + oxaliplatin for 8 3-week cycles
Metastatic Breast Cancer: capecitabine alone or capecitabine + docetaxel for 8 3-week cycles.

All patients will be given a mobile phone onto which they will enter any side-effects experienced prior to taking capecitabine in the morning and evening. Any grade 3 or 4 symptoms will trigger an alert to a pager held by the ward-staff for immediate attention. Thus, patients' severe side-effects will be monitored in real time and the trial will allow real-time dose reductions during cycles and dose-increases at clinics. Patient experience in the trial will also be evaluated during their participation in the trial.

Patients will already be receiving the drug prior to this study and will not be administered to patients as part of this study.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Metastatic colorectal or breast cancer patients commencing treatment on one of four specified regimens

For metastatic colorectal cancer:

capecitabine 2000mg/m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (CAPOX)
capecitabine 2500mg/m2 d 1-14, q 3 weekly

For metastatic breast cancer:

capecitabine 2000mg/m2d 1-14, q 3 weekly
capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3 weekly
Age > 18 years
Fit to start at full (100%) starting dose of all drugs
Able and willing to use mobile phone
Reasonable renal, liver and bone marrow function
Absolute neutrophil count (ANC) >1.5 x 109/L
Platelet count > 100 x 109/L
Total bilirubin <1.5 ULN
ALT, AST < 2.5 x ULN
Alkaline phosphatase < 2.5 x ULN
No obvious contra indications to capecitabine or oxaliplatin or docetaxel
Patients must also be able to read, write and understand English.

Exclusion criteria

Patients who live in an area of no Vodafone or Orange mobile phone network - - Patients participating in other cancer treatment trials
Moderate or severe renal impairment [creatinine clearance <30ml/min (calculated according to Cockroft-Gault formula)]