Trial Outcomes & Findings for Acupuncture for Chronic Lymphedema (NCT NCT01706081)
NCT ID: NCT01706081
Last Updated: 2019-08-29
Results Overview
Changes in lymphedema between groups, as measured by mean arm circumference assessed at baseline and after 6 weeks from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
6 weeks
Results posted on
2019-08-29
Participant Flow
Participant milestones
| Measure |
Acupuncture
Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.
Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation.
|
Wait-list
Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.
Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
42
|
|
Overall Study
COMPLETED
|
40
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture for Chronic Lymphedema
Baseline characteristics by cohort
| Measure |
Acupuncture
n=40 Participants
Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.
Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation.
|
Wait-list
n=42 Participants
Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.
Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
58 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksChanges in lymphedema between groups, as measured by mean arm circumference assessed at baseline and after 6 weeks from baseline.
Outcome measures
| Measure |
Acupuncture
n=40 Participants
Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.
Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation.
|
Wait-list
n=42 Participants
Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.
Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints.
|
|---|---|---|
|
Lymphedema as Measured at Baseline and at 6 Weeks
Baseline
|
4.74 cm
Standard Deviation 2.23
|
4.82 cm
Standard Deviation 2.32
|
|
Lymphedema as Measured at Baseline and at 6 Weeks
6 weeks
|
4.29 cm
Standard Deviation 2.67
|
4.76 cm
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: 6 weeksBioimpedance measured using Impedimed L-Dex U400, which measures the rate of electrical current transmission through tissues and estimate fluid content in a lymphedematous limb compared with the normal limb.
Outcome measures
| Measure |
Acupuncture
n=40 Participants
Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.
Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation.
|
Wait-list
n=42 Participants
Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.
Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints.
|
|---|---|---|
|
Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks
Baseline
|
38.6 ohms
Standard Deviation 30.4
|
42.2 ohms
Standard Deviation 32.3
|
|
Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks
6 Week
|
35.9 ohms
Standard Deviation 27.4
|
40.3 ohms
Standard Deviation 35.6
|
SECONDARY outcome
Timeframe: 1. 5 yearsOutcome measures
| Measure |
Acupuncture
n=40 Participants
Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.
Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation.
|
Wait-list
n=42 Participants
Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.
Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints.
|
|---|---|---|
|
Number of Participants Evaluated for Adverse Events
|
40 Participants
|
42 Participants
|
Adverse Events
Acupuncture
Serious events: 12 serious events
Other events: 20 other events
Deaths: 6 deaths
Wait-list
Serious events: 7 serious events
Other events: 11 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Acupuncture
n=40 participants at risk
Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.
Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation.
|
Wait-list
n=42 participants at risk
Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.
Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
2/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
General disorders
Gen disorders & admin site conditions Other, spec
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Investigations
Neutrophil count decreased
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Investigations
Platelet count decreased
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders Other, spec
|
2.5%
1/40 • 1 year
|
4.8%
2/42 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
Other adverse events
| Measure |
Acupuncture
n=40 participants at risk
Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks.
Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation.
|
Wait-list
n=42 participants at risk
Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.
Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.5%
3/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.5%
3/40 • 1 year
|
7.1%
3/42 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
5.0%
2/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Investigations
Neutrophil count decreased
|
10.0%
4/40 • 1 year
|
4.8%
2/42 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
2/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Investigations
Platelet count decreased
|
5.0%
2/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Investigations
White blood cell decreased
|
10.0%
4/40 • 1 year
|
4.8%
2/42 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/40 • 1 year
|
4.8%
2/42 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place