Clinical trial NCT01053104: Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring
Official title: Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring Pilot Study of Optimal Dose Scheduling of Capecitabine for Patients With Metastatic Colorectal or Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Metastatic Breast Cancer
Keywords: Colorectal cancer
Breast cancer
Capecitabine
Docetaxel
Mobile phone
Toxicity
Metastatic
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: oxBRC
name: Vodafone UK Foundation
name: Centre for Statistics in Medicine
name: Oncology Clinical Trials Office (OCTO, Oxford)
First posted: 2010-01-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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

Detailed 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.

Eligibility criteria: 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 \[creatinine clearance \<30ml/min (calculated according to Cockroft-Gault formula)\]

Primary outcomes:
measure: Toxicities (frequency at each of grades 2, 3 and 4, over all cycles)
timeFrame: At the end of each cycle and at occurrence
Secondary outcomes:
measure: Number of inappropriate dose adaptations and self care advice messages generated ['inappropriate' defined by nurse overriding generated advice
timeFrame: At occurrence
measure: Frequency of patients receiving each piece of advice from the system, including recommendations on dose and on self-treating side effects.
timeFrame: At occurrence
measure: Obtain descriptive information on amount and duration of drug delivery (stage 2 only) Number of patients who, dose reduce stay at same dose dose increase Total dose delivery Chemotherapy duration
timeFrame: Twice daily
measure: Obtain feedback from staff on using the system Staff recommendations for changes or improvements to the system throughout the course of the study and Semi-structured interviews
timeFrame: weekly for staff recommendations and one semi structured interview will take place
measure: Test and refine mobile phone and server software systems Frequency of occurrence of technological faults (for example, problems caused by no phone reception)
timeFrame: At occurrence
measure: Patient Experience EvaluationPatient experience will be evaluated as detailed in Patient Experience Evaluation
timeFrame: At least twice during their participation in the trial but not all patients may need to be interviewed
measure: Evaluate safety outcomes Total number of grade 3/4 toxicities throughout the study period Degree of toxicity experienced Number of alerts, split by severity
timeFrame: End of each cycle and at occurrence
measure: Dose intensity in mg/m2/week and toxicities as for stage 1
timeFrame: Once at the end of the study for each patient
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Cancer Centre, Churchill Hospital
Study officials:
References: