Trial Outcomes & Findings for Glutamine in Preventing Myalgia and/or Arthralgia in Patients Who Are Receiving Paclitaxel For Cancer (NCT NCT00217724)
NCT ID: NCT00217724
Last Updated: 2017-05-09
Results Overview
Complete Response (CR): Complete absence of myalgias or arthralgias Partial Response (PR): Myalgias and/or arthralgias occur but are attenuated in the cycle in which they receive active therapy by \> 50% Stable Disease (SD): Less than 25% change in incidence, duration, or severity of myalgias/arthralgias Progressive Disease (PD): Symptoms worsen by \>25% from baseline scores
TERMINATED
NA
18 participants
2 courses of chemotherapy (6 weeks)
2017-05-09
Participant Flow
Participants were recruited from oncology clinics at OHSU.
Participant milestones
| Measure |
Oral Glutamine x 4 Days
Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days starting day 2 of course 1 during Paclitaxel treatment.
|
Oral Placebo x 4 Days
Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days starting day 2 of course 1 during Paclitaxel treatment.
|
|---|---|---|
|
Course 1, (Glutamine/Placebo Arms)
STARTED
|
8
|
10
|
|
Course 1, (Glutamine/Placebo Arms)
COMPLETED
|
5
|
9
|
|
Course 1, (Glutamine/Placebo Arms)
NOT COMPLETED
|
3
|
1
|
|
Course 2, (Glutamine/Placebo Crossover)
STARTED
|
9
|
5
|
|
Course 2, (Glutamine/Placebo Crossover)
COMPLETED
|
8
|
5
|
|
Course 2, (Glutamine/Placebo Crossover)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glutamine in Preventing Myalgia and/or Arthralgia in Patients Who Are Receiving Paclitaxel For Cancer
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=18 Participants
Includes those randomized to Arms 1 and 2 in both course 1 and 2.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
|
Cancer Diagnosis
Breast
|
11 Participants
n=5 Participants
|
|
Cancer Diagnosis
Ovarian
|
5 Participants
n=5 Participants
|
|
Cancer Diagnosis
Esophageal
|
1 Participants
n=5 Participants
|
|
Cancer Diagnosis
Uterine sarcoma
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 courses of chemotherapy (6 weeks)Population: Fourteen of the 18 patients enrolled received both cycles of therapy and were thus evaluable for the primary endpoint
Complete Response (CR): Complete absence of myalgias or arthralgias Partial Response (PR): Myalgias and/or arthralgias occur but are attenuated in the cycle in which they receive active therapy by \> 50% Stable Disease (SD): Less than 25% change in incidence, duration, or severity of myalgias/arthralgias Progressive Disease (PD): Symptoms worsen by \>25% from baseline scores
Outcome measures
| Measure |
Oral Glutamine x 4 Days
n=14 Participants
Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
|
Oral Placebo x 4 Days
n=14 Participants
Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
|
|---|---|---|
|
Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy
Complete Response
|
0 participants
|
0 participants
|
|
Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy
Partial Response
|
3 participants
|
4 participants
|
|
Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy
Stable Disease (SD)/Progressive Disease (PD)
|
11 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Duration of participation on study (up to one year)Outcome measures
Outcome data not reported
Adverse Events
Oral Glutamine x 4 Days
Oral Placebo x 4 Days
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