Metastatic Colorectal CancerDATACAPNCT01053104
Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring
An observational study of Metastatic Colorectal Cancer and Metastatic Breast Cancer, run by University of Oxford at 1 site in United Kingdom.
Trial summary
To develop a system to manage side effects and adjust chemotherapy dose such that a patient can receive their personal maximum tolerated dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Metastatic Breast Cancer
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2009to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Show all 18Show fewer
- 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.
Who cannot join
- 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)]
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Cancer Centre, Churchill Hospital
Oxford, OX3 7LJ
About this study
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
To develop a system to manage side effects and adjust chemotherapy dose such that a patient can receive their personal maximum tolerated dose.
Read the 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.
- Keywords
- Colorectal cancer, Breast cancer, Capecitabine, Docetaxel, Mobile phone, Toxicity, Metastatic
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Toxicities (frequency at each of grades 2, 3 and 4, over all cycles)
Measured: At the end of each cycle and at occurrence
Secondary outcomes (8)
Number of inappropriate dose adaptations and self care advice messages generated ['inappropriate' defined by nurse overriding generated advice
Measured: At occurrence
Frequency of patients receiving each piece of advice from the system, including recommendations on dose and on self-treating side effects.
Measured: 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
Measured: 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
Measured: 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)
Measured: At occurrence
Patient Experience EvaluationPatient experience will be evaluated as detailed in Patient Experience Evaluation
Measured: 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
Measured: End of each cycle and at occurrence
Dose intensity in mg/m2/week and toxicities as for stage 1
Measured: Once at the end of the study for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- oxBRC, Vodafone UK Foundation, Centre for Statistics in Medicine, Oncology Clinical Trials Office (OCTO, Oxford)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053104
- Sponsor's protocol ID
- Mobile Datacap
- Other IDs
- OCTO/Oxford
- Acronym
- DATACAP
- Status last verified
- Jul 2012
- First submitted
- 3 Jan 2010
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01053104
- Acronym / sponsor ID
- DATACAP / Mobile Datacap
- Keywords
- Colorectal cancer, Breast cancer, Capecitabine, Docetaxel, Mobile phone, Toxicity, Metastatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- oxBRC, Vodafone UK Foundation, Centre for Statistics in Medicine, Oncology Clinical Trials Office (OCTO, Oxford)
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (18 listed)
- Metastatic colorectal or breast cancer patients commencing treatment on one of four specified regimens
- 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
- 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
Key exclusion criteria (2 listed)
- 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)]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Toxicities (frequency at each of grades 2, 3 and 4, over all cycles)
Time frame: At the end of each cycle and at occurrence
8 secondary outcomes
Number of inappropriate dose adaptations and self care advice messages generated ['inappropriate' defined by nurse overriding generated advice
Time frame: 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
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
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
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
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
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
Dose intensity in mg/m2/week and toxicities as for stage 1
Time frame: Once at the end of the study for each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
- Oncology Clinical Trials Office (OCTO)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer and Metastatic Breast Cancer, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2012.