Trial Outcomes & Findings for Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer (NCT NCT00998738)
NCT ID: NCT00998738
Last Updated: 2016-02-04
Results Overview
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) sensor subscale score was calculated following the standard scoring algorithm and was transformed to a 0 to 100 scale with 0=Low QOL and 100=Best QOL for data analysis.
TERMINATED
PHASE3
1 participants
During the first 18 weeks of ixabepilone-based therapy
2016-02-04
Participant Flow
One participant was recruited between November 2009 and July 2010 at Mayo Clinic. This trial was terminated in July 2010 due to lack of accrual. Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Participant milestones
| Measure |
Overall
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Overall
|
|---|---|
|
Overall Study
Uknown
|
1
|
Baseline Characteristics
Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: During the first 18 weeks of ixabepilone-based therapyPopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) sensor subscale score was calculated following the standard scoring algorithm and was transformed to a 0 to 100 scale with 0=Low QOL and 100=Best QOL for data analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 months from initiation of ixabepilonePopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 months from initiation of ixabepilonePopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Time to onset of grade 2+ neurotoxicity was defined as time from randomization to the first occurrence of grade 2+ neurotoxicity. Time to onset of grade 3+ neurotoxicity was defined as time from randomization to the first occurrence of grade 3+ neurotoxicity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 months from initiation of ixabepilonePopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 months from initiation of ixabepilonePopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 months from initiation of ixabepilonePopulation: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Treatment initiation to day 21 (Cycle 1)Population: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
APS was measured using the pain item which evaluated the aches/pains at its WORST in the last 24 hours in the scale of 0 to 10, with 0=no aches/pain and 10=aches/pains as bad as can be. The outcome measures for each subsequent cycle will be analyzed in a similar fashion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Treatment initiation to day 21 (Cycle 1)Population: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
APS was measured using the pain item which evaluated the aches/pains at its WORST in the last 24 hours in the scale of 0 to 10, with 0=no aches/pain and 10=aches/pains as bad as can be. The outcome measures for each subsequent cycle will be analyzed in a similar fashion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First cycle of therapy (up to 21 days)Population: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Correlation coefficients will be produced relating the worst pain scores in the first cycle of therapy and the subsequent neuropathy scores as judged from the daily and weekly questions.
Outcome measures
Outcome data not reported
Adverse Events
Overall
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place