NCT01053104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2010

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

July 25, 2012

Status Verified

July 1, 2012

Enrollment Period

1.1 years

First QC Date

January 3, 2010

Last Update Submit

July 24, 2012

Conditions

Metastatic Colorectal CancerMetastatic Breast Cancer

Keywords

Colorectal cancerBreast cancerCapecitabineDocetaxelMobile phoneToxicityMetastatic

Outcome Measures

Primary Outcomes (1)

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

    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

    At occurrence

  • Frequency of patients receiving each piece of advice from the system, including recommendations on dose and on self-treating side effects.

    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

    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

    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)

    At occurrence

  • +3 more secondary outcomes

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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 \[creatinine clearance \<30ml/min (calculated according to Cockroft-Gault formula)\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Cancer Centre, Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsBreast NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2010

First Posted

January 21, 2010

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

April 1, 2011

Last Updated

July 25, 2012

Record last verified: 2012-07

Locations

GB(1)