Trial Outcomes & Findings for Glucosamine and Chondroitin for Aromatase Inhibitor Induced Joint Symptoms in Women With Breast Cancer (NCT NCT00691678)
NCT ID: NCT00691678
Last Updated: 2022-11-08
Results Overview
This is to demonstrate improvement in knee and/or joint pain and/or stiffness. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The sum of the scores for all three subscales gives a total WOMAC score which ranges from 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
COMPLETED
PHASE2
53 participants
Baseline and 24 weeks
2022-11-08
Participant Flow
53 women were enrolled in this study at baseline, 16 dropped out before the week 24 assessment. in total, there were 39 evaluable participants.
Of the 16 participants that dropped out of the study, 5 did so because of the number of pills, 8 due to adverse events and uncontrolled pain, and 3 dropped out due to other life events. 40 participants completed the 12 week assessment; 27 participants completed the 24 week assessment.
Participant milestones
| Measure |
Chondroitin and Glucosamine
Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.
Chondroitin: 400mg chondroitin three times a day (TID) for twenty-four weeks
Glucosamine: 500mg glucosamine TID for twenty-four weeks
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Chondroitin and Glucosamine
Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.
Chondroitin: 400mg chondroitin three times a day (TID) for twenty-four weeks
Glucosamine: 500mg glucosamine TID for twenty-four weeks
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
life events, pain
|
11
|
Baseline Characteristics
Glucosamine and Chondroitin for Aromatase Inhibitor Induced Joint Symptoms in Women With Breast Cancer
Baseline characteristics by cohort
| Measure |
Chondroitin and Glucosamine
n=53 Participants
Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.
Chondroitin: 400mg chondroitin TID for twenty-four weeks
Glucosamine: 500mg glucosamine TID for twenty-four weeks
|
|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=99 Participants
|
|
Age, Customized
18 - 58 years
|
23 Participants
n=99 Participants
|
|
Age, Customized
59 - 78 years
|
24 Participants
n=99 Participants
|
|
Age, Customized
> or = 79
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: At completion of the study, there were 39 evaluable subjects (this excludes participants who were not available for follow-up) out of the 53 enrolled.
This is to demonstrate improvement in knee and/or joint pain and/or stiffness. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The sum of the scores for all three subscales gives a total WOMAC score which ranges from 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Outcome measures
| Measure |
Chondroitin and Glucosamine
n=39 Participants
Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.
Chondroitin: 400mg chondroitin TID for twenty-four weeks
Glucosamine: 500mg glucosamine TID for twenty-four weeks
|
|---|---|
|
Change in WOMAC Score
|
24.9 Score on a scale
Standard Deviation 21.4
|
Adverse Events
Chondroitin and Glucosamine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chondroitin and Glucosamine
n=53 participants at risk
Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.
Chondroitin: 400mg chondroitin TID for twenty-four weeks
Glucosamine: 500mg glucosamine TID for twenty-four weeks
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
17.0%
9/53 • Number of events 9 • Up to 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
17.0%
9/53 • Number of events 9 • Up to 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
7.5%
4/53 • Number of events 4 • Up to 24 weeks
|
|
Gastrointestinal disorders
Flatulence
|
5.7%
3/53 • Number of events 3 • Up to 24 weeks
|
|
Gastrointestinal disorders
Heartburn
|
3.8%
2/53 • Number of events 2 • Up to 24 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.9%
1/53 • Number of events 1 • Up to 24 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
1.9%
1/53 • Number of events 1 • Up to 24 weeks
|
|
Gastrointestinal disorders
Gastritis
|
1.9%
1/53 • Number of events 1 • Up to 24 weeks
|
|
Gastrointestinal disorders
Hiccough
|
1.9%
1/53 • Number of events 1 • Up to 24 weeks
|
|
Gastrointestinal disorders
Stomach Pain
|
1.9%
1/53 • Number of events 1 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Weight gain
|
1.9%
1/53 • Number of events 1 • Up to 24 weeks
|
|
Nervous system disorders
Headache
|
26.4%
14/53 • Number of events 14 • Up to 24 weeks
|
|
Nervous system disorders
Fatigue
|
3.8%
2/53 • Number of events 2 • Up to 24 weeks
|
|
Immune system disorders
Allergic reaction
|
1.9%
1/53 • Number of events 1 • Up to 24 weeks
|
|
Investigations
Bleeding at the biopsy site
|
1.9%
1/53 • Number of events 1 • Up to 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place