Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring

Metastatic Breast Cancer Clinical Trial

— DATACAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053104
• Other study ID #: Mobile Datacap
• Secondary ID: OCTO/Oxford
• Status: Completed
• Phase: N/A
• First received: January 3, 2010
• Last updated: July 24, 2012
• Start date: November 2009
• Est. completion date: April 2011

Study information

• Verified date: July 2012
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: Oxfordshire research ethics committee A, country name: United Kingdom
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)]

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Colorectal Neoplasms
• Metastatic Breast Cancer
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
United Kingdom	Oxford Cancer Centre, Churchill Hospital	Oxford

Sponsors (5)

Lead Sponsor	Collaborator
University of Oxford	Centre of Statistics and Medicine (CSM, Oxford), Oncology Clinical Trials Office (OCTO, Oxford), oxBRC, Vodafone UK Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicities (frequency at each of grades 2, 3 and 4, over all cycles)		At the end of each cycle and at occurrence	Yes
Secondary	Number of inappropriate dose adaptations and self care advice messages generated ['inappropriate' defined by nurse overriding generated advice		At occurrence	No
Secondary	Frequency of patients receiving each piece of advice from the system, including recommendations on dose and on self-treating side effects.		At occurrence	No
Secondary	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		Twice daily	No
Secondary	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		weekly for staff recommendations and one semi structured interview will take place	No
Secondary	Test and refine mobile phone and server software systems Frequency of occurrence of technological faults (for example, problems caused by no phone reception)		At occurrence	No
Secondary	Patient Experience EvaluationPatient experience will be evaluated as detailed in Patient Experience Evaluation		At least twice during their participation in the trial but not all patients may need to be interviewed	No
Secondary	Evaluate safety outcomes Total number of grade 3/4 toxicities throughout the study period Degree of toxicity experienced Number of alerts, split by severity		End of each cycle and at occurrence	Yes
Secondary	Dose intensity in mg/m2/week and toxicities as for stage 1		Once at the end of the study for each patient	No

External Links

•   Oncology Clinical Trials Office (OCTO)