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

July 24, 2012 updated by: University of Oxford

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 7LJ
        • Oxford Cancer Centre, Churchill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
capecitabine 2000mg/m2 (Colorectal)
capecitabine 2000mg/m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (CAPOX)
capecitabine 2500mg/m2 (Colorectal)
capecitabine 2500mg/m2 d 1-14, q 3 weekly
capecitabine 2000mg/m2 (Breast)
capecitabine 2000mg/m2d 1-14, q 3 weekly
docetaxel 75mg/m2 (Breast)
capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3 weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicities (frequency at each of grades 2, 3 and 4, over all cycles)
Time Frame: At the end of each cycle and at occurrence
At the end of each cycle and at occurrence

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

oxBRC
Vodafone UK Foundation
Centre for Statistics in Medicine
Oncology Clinical Trials Office (OCTO, Oxford)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 3, 2010

First Submitted That Met QC Criteria

January 19, 2010

First Posted (Estimate)

January 21, 2010

Study Record Updates

Last Update Posted (Estimate)

July 25, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mobile Datacap
  • OCTO/Oxford (Other Identifier: Trial coordinating centre)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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