Skip to main content
OpenTrials
Completed

NCT Number: NCT01053104

Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Colorectal Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metastatic Breast Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oxford Cancer Centre, Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)]

Treatment and study plan

Primary outcomes

  1. Toxicities (frequency at each of grades 2, 3 and 4, over all cycles)

    Time frame: At the end of each cycle and at occurrence

Secondary outcomes

  1. Number of inappropriate dose adaptations and self care advice messages generated ['inappropriate' defined by nurse overriding generated advice

    Time frame: At occurrence

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Dose intensity in mg/m2/week and toxicities as for stage 1

    Time frame: Once at the end of the study for each patient

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

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

Registry information

Official study 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

Acronym: DATACAP

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jan 21, 2010
Registry last updated
Jul 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.