Clinical trial · Observational
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
NCT01053104CI-TRIAL-00007552DATACAPcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To develop a system to manage side effects and adjust chemotherapy dose such that a patient can receive their personal maximum tolerated dose.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- capecitabine 2000mg/m2 (Colorectal)
- description
- capecitabine 2000mg/m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (CAPOX)
- label
- capecitabine 2500mg/m2 (Colorectal)
- description
- capecitabine 2500mg/m2 d 1-14, q 3 weekly
- label
- capecitabine 2000mg/m2 (Breast)
- description
- capecitabine 2000mg/m2d 1-14, q 3 weekly
- label
- docetaxel 75mg/m2 (Breast)
- description
- capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3 weekly
Primary outcomes (1)
- measure
- Toxicities (frequency at each of grades 2, 3 and 4, over all cycles)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \[creatinine clearance \<30ml/min (calculated according to Cockroft-Gault formula)\]
References
Publications (0)
Data not yet available
No reference posted for this study.