Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-30 @ 3:55 AM
Study NCT ID:
NCT01053104
Status:
COMPLETED
Last Update Posted:
2012-07-25
First Post:
2010-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring
Sponsor:
University of Oxford
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DATACAP
Brief Summary:
To develop a system to manage side effects and adjust chemotherapy dose such that a patient can receive their personal maximum tolerated dose.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| OCTO/Oxford | OTHER | Trial coordinating centre | View |