Trial Outcomes & Findings for A Pilot Study of Acupuncture Treatment for Dysphagia (NCT NCT00797732)
NCT ID: NCT00797732
Last Updated: 2018-02-13
Results Overview
Outcome compliance rate is the percentage of enrolled participants who completed the primary study assessments (at baseline and in long-term follow-up 6 months post acupuncture treatment).
COMPLETED
NA
42 participants
Assessed at baseline and at 6 months post acupuncture treatment
2018-02-13
Participant Flow
Patients were screened for potential enrollment from January 2009 through December 2011.
Since one primary aim was to assess feasibility as measured by recruitment the screening non-randomized count is included in the participant flow.
Participant milestones
| Measure |
Active Acupuncture
The active intervention used a three-phase step-up protocol to gradually increase the body areas treated and needling intensity. Acupuncture needles (0.20x25mm) were inserted with a depth of 5-10 mm into predefined points based on a systematic literature review following the STRICTA guideline. Needles were stimulated to obtain the de qi sensation. An electroacupuncture (EA) device was connected at two acupoints. All needles remained in place for 30 minutes. The active acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. \[Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; MacPherson H, Altman DG et al. PLoS Med 2010;7:e1000261\]
|
Sham Acupuncture
The sham intervention was designed to be maximally inert and minimally invasive, while simulating most aspects of the active protocol. Sham needles (0.12x30mm) were inserted at 14 locations paralleling the same body regions needled in the active group; however, all sham point locations were off the pathways of traditional Chinese medicine acupuncture meridians and points. An identical but deactivated EA device was used following sham protocols previously used. The sham acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. \[Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; Wayne PA, Krebs DE et al. Arch Phys Med Rehabil 2005; 86:2248-2255\]
|
Screened Non-Randomized
Participants approached in the screening process but ultimately not randomized.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
154
|
|
Overall Study
Evaluable at Baseline
|
18
|
18
|
0
|
|
Overall Study
Evaluable at 20 Weeks
|
17
|
18
|
0
|
|
Overall Study
Evaluable at 12 Months
|
17
|
18
|
0
|
|
Overall Study
COMPLETED
|
16
|
18
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
154
|
Reasons for withdrawal
| Measure |
Active Acupuncture
The active intervention used a three-phase step-up protocol to gradually increase the body areas treated and needling intensity. Acupuncture needles (0.20x25mm) were inserted with a depth of 5-10 mm into predefined points based on a systematic literature review following the STRICTA guideline. Needles were stimulated to obtain the de qi sensation. An electroacupuncture (EA) device was connected at two acupoints. All needles remained in place for 30 minutes. The active acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. \[Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; MacPherson H, Altman DG et al. PLoS Med 2010;7:e1000261\]
|
Sham Acupuncture
The sham intervention was designed to be maximally inert and minimally invasive, while simulating most aspects of the active protocol. Sham needles (0.12x30mm) were inserted at 14 locations paralleling the same body regions needled in the active group; however, all sham point locations were off the pathways of traditional Chinese medicine acupuncture meridians and points. An identical but deactivated EA device was used following sham protocols previously used. The sham acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. \[Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; Wayne PA, Krebs DE et al. Arch Phys Med Rehabil 2005; 86:2248-2255\]
|
Screened Non-Randomized
Participants approached in the screening process but ultimately not randomized.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Not meet inclusion criteria
|
0
|
0
|
7
|
|
Overall Study
Excluded due to time constraints
|
0
|
0
|
24
|
|
Overall Study
Refused to Participate
|
0
|
0
|
123
|
Baseline Characteristics
A Pilot Study of Acupuncture Treatment for Dysphagia
Baseline characteristics by cohort
| Measure |
Active Acupuncture
n=21 Participants
Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
|
Sham Acupuncture
n=21 Participants
TBoth active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
59.1 years
STANDARD_DEVIATION 8.3 • n=107 Participants
|
58.2 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Total IMRT dose (Gy)
58 Gy
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Total IMRT dose (Gy)
64 GY
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Total IMRT dose (Gy)
66 Gy
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Total IMRT dose (Gy)
70 Gy
|
19 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline and at 6 months post acupuncture treatmentPopulation: The analysis population is comprised of all randomized participants.
Outcome compliance rate is the percentage of enrolled participants who completed the primary study assessments (at baseline and in long-term follow-up 6 months post acupuncture treatment).
Outcome measures
| Measure |
Active Acupuncture
n=21 Participants
Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
|
Sham Acupuncture
n=21 Participants
Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
|
|---|---|---|
|
Outcome Compliance Rate
|
76.2 percentage of participants
Interval 52.8 to 91.8
|
85.7 percentage of participants
Interval 63.6 to 97.0
|
PRIMARY outcome
Timeframe: Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks)Population: The analysis population is comprised of all randomized participants.
Treatment compliance rate is the percentage of enrolled participants who completed at least 80% of treatment (10 of 12 acupuncture sessions).
Outcome measures
| Measure |
Active Acupuncture
n=21 Participants
Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
|
Sham Acupuncture
n=21 Participants
Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
|
|---|---|---|
|
Treatment Compliance Rate
|
76.2 percentage of participants
Interval 52.8 to 91.8
|
81.0 percentage of participants
Interval 58.1 to 94.6
|
SECONDARY outcome
Timeframe: Assessed at baseline and 6 months post acupuncture which parallels 12 months post-CRTPopulation: The analysis population represents the subset of participants evaluable at baseline and 12 months post CRT/6 months post acupuncture
The M.D. Anderson Dysphagia Inventory (MDADI) is a validated, self-administered questionnaire established as the best measure of dysphagia-related quality of life in HNC patients. (Carlsson S, et al Dysphagia 2012; 27: 361-369). MDADI has two summary scores: 1) global (1 item) and 2) composite (19 items). Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score is a weighted average of the physical, emotional, and functional subscale questions. Scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). A minimal clinically important within group difference was a 10% change from baseline.
Outcome measures
| Measure |
Active Acupuncture
n=16 Participants
Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
|
Sham Acupuncture
n=18 Participants
Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
|
|---|---|---|
|
MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT)
|
7.9 units on a scale
Interval 0.2 to 15.6
|
13.9 units on a scale
Interval 6.4 to 21.4
|
SECONDARY outcome
Timeframe: Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncturePopulation: The analysis population is comprised of all randomized participants. At each timepoint, a subset of participants were evaluable for quality of life assessment.
The M.D. Anderson Dysphagia Inventory (MDADI) is a validated, self-administered questionnaire established as the best measure of dysphagia-related quality of life in HNC patients. (Carlsson S, et al Dysphagia 2012; 27: 361-369). MDADI has two summary scores: 1) global (1 item) and 2) composite (19 items). Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score is a weighted average of the physical, emotional, and functional subscale questions. Scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). A minimal clinically important within group difference was a 10% change from baseline.
Outcome measures
| Measure |
Active Acupuncture
n=21 Participants
Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
|
Sham Acupuncture
n=21 Participants
Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
|
|---|---|---|
|
MDADI Scores
Baseline
|
60.3 units on a scale
Standard Deviation 14.7
|
69.2 units on a scale
Standard Deviation 15.5
|
|
MDADI Scores
20 weeks post chemoradiation start
|
68.7 units on a scale
Standard Deviation 13.3
|
77.8 units on a scale
Standard Deviation 10.9
|
|
MDADI Scores
6 months post acupuncture start
|
72.7 units on a scale
Standard Deviation 13.3
|
79.3 units on a scale
Standard Deviation 12.4
|
Adverse Events
Active Acupuncture
Sham Acupuncture
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Acupuncture
n=21 participants at risk
Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
|
Sham Acupuncture
n=21 participants at risk
Both active and sham acupuncture were administered by 5 experienced staff acupuncturists employing a traditional Chinese medicine (TCM) style, once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Bruising
|
4.8%
1/21 • Number of events 1 • Adverse events were evaluated throughout treatment at each visit up to end of treatment week 20 after CRT.
|
0.00%
0/21 • Adverse events were evaluated throughout treatment at each visit up to end of treatment week 20 after CRT.
|
Additional Information
Weidong Lu, PhD, MB, Lic.Ac.
Dana-Farber Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place