Trial Outcomes & Findings for L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer (NCT NCT00754767)
NCT ID: NCT00754767
Last Updated: 2017-09-11
Results Overview
Data was not analyzed due to study termination
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
2 participants
Primary outcome timeframe
baseline, days 1 and 2 post chemo x 4 cycles
Results posted on
2017-09-11
Participant Flow
oncology clinic
Participant milestones
| Measure |
Arm I
Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
L-carnitine L-tartrate: Given orally
|
Arm II
Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
placebo: Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm I
n=2 Participants
Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
L-carnitine L-tartrate: Given orally
|
Arm II
Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
placebo: Given orally
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
0 Participants
|
2 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
0 Participants
|
2 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
0 Participants
|
0 Participants
n=2 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: baseline, days 1 and 2 post chemo x 4 cyclesData was not analyzed due to study termination
Outcome measures
Outcome data not reported
Adverse Events
Arm I L-Carnitine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II-Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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