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
  Purpose

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


Condition
Metastatic Colorectal Cancer
Metastatic Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: November 2009
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

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)]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053104

Locations
United Kingdom
Oxford Cancer Centre, Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
University of Oxford
oxBRC
Vodafone UK Foundation
Centre of Statistics and Medicine (CSM, Oxford)
Oncology Clinical Trials Office (OCTO, Oxford)
  More Information

Additional Information:
No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01053104     History of Changes
Other Study ID Numbers: Mobile Datacap, OCTO/Oxford
Study First Received: January 3, 2010
Last Updated: July 24, 2012
Health Authority: Oxfordshire research ethics committee A, country name: United Kingdom

Keywords provided by University of Oxford:
Colorectal cancer
Breast cancer
Capecitabine
Docetaxel
Mobile phone
Toxicity
Metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Docetaxel
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014