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

This study has been completed.
Sponsor:
Collaborators:
oxBRC
Vodafone UK Foundation
Centre of Statistics and Medicine (CSM, Oxford)
Oncology Clinical Trials Office (OCTO, Oxford)
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01053104
First received: January 3, 2010
Last updated: July 24, 2012
Last verified: July 2012

January 3, 2010
July 24, 2012
November 2009
December 2010   (final data collection date for primary outcome measure)
Toxicities (frequency at each of grades 2, 3 and 4, over all cycles) [ Time Frame: At the end of each cycle and at occurrence ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01053104 on ClinicalTrials.gov Archive Site
  • Number of inappropriate dose adaptations and self care advice messages generated ['inappropriate' defined by nurse overriding generated advice [ Time Frame: At occurrence ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Dose intensity in mg/m2/week and toxicities as for stage 1 [ Time Frame: Once at the end of the study for each patient ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary care clinic

  • Metastatic Colorectal Cancer
  • Metastatic Breast Cancer
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
April 2011
December 2010   (final data collection date for primary outcome measure)

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)]
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01053104
Mobile Datacap, OCTO/Oxford
No
University of Oxford
University of Oxford
  • oxBRC
  • Vodafone UK Foundation
  • Centre of Statistics and Medicine (CSM, Oxford)
  • Oncology Clinical Trials Office (OCTO, Oxford)
Not Provided
University of Oxford
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP