NCT00797732 · STUDY IN CONTEXT

A Pilot Study of Acupuncture Treatment for Dysphagia

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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).

The analysis population is comprised of all randomized participants.

→

primary · POSTED

Treatment compliance rate is the percentage of enrolled participants who completed at least 80% of treatment (10 of 12 acupuncture sessions).

The analysis population is comprised of all randomized participants.

→

secondary · POSTED

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.

The analysis population represents the subset of participants evaluable at baseline and 12 months post CRT/6 months post acupuncture

→

secondary · POSTED

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.

The analysis population is comprised of all randomized participants. At each timepoint, a subset of participants were evaluable for quality of life assessment.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

Unnamed quality-of-life measure · MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-squamous-cell-carcinoma
nct id: NCT00797732
qol key: qol-0002
source section id: NCT00797732-om-0002
source outcome index: 2
instrument: Unnamed quality-of-life measure
instrument basis: matched 'quality of life' in the study's own wording
scale title: MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT)
measure definition: 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.
time frame: Assessed at baseline and 6 months post acupuncture which parallels 12 months post-CRT
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: The analysis population represents the subset of participants evaluable at baseline and 12 months post CRT/6 months post acupuncture
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Unnamed quality-of-life measure · MDADI Scores

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-squamous-cell-carcinoma
nct id: NCT00797732
qol key: qol-0003
source section id: NCT00797732-om-0003
source outcome index: 3
instrument: Unnamed quality-of-life measure
instrument basis: matched 'quality of life' in the study's own wording
scale title: MDADI Scores
measure definition: 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.
time frame: Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncture
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: The analysis population is comprised of all randomized participants. At each timepoint, a subset of participants were evaluable for quality of life assessment.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-squamous-cell-carcinoma
nct id: NCT00797732
trial label: A Pilot Study of Acupuncture Treatment for Dysphagia
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 2
qol Count: 2

outcomes

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
outcome key
om-0000
source section id
NCT00797732-om-0000
source outcome index
0
endpoint
Outcome Compliance Rate
endpoint definition
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).
time origin
Assessed at baseline and at 6 months post acupuncture treatment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population is comprised of all randomized participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
outcome key
om-0001
source section id
NCT00797732-om-0001
source outcome index
1
endpoint
Treatment Compliance Rate
endpoint definition
Treatment compliance rate is the percentage of enrolled participants who completed at least 80% of treatment (10 of 12 acupuncture sessions).
time origin
Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population is comprised of all randomized participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
outcome key
om-0002
source section id
NCT00797732-om-0002
source outcome index
2
endpoint
MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT)
endpoint definition
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.
time origin
Assessed at baseline and 6 months post acupuncture which parallels 12 months post-CRT
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population represents the subset of participants evaluable at baseline and 12 months post CRT/6 months post acupuncture
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
outcome key
om-0003
source section id
NCT00797732-om-0003
source outcome index
3
endpoint
MDADI Scores
endpoint definition
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.
time origin
Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncture
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population is comprised of all randomized participants. At each timepoint, a subset of participants were evaluable for quality of life assessment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
outcome key
om-0000
arm key
OG000
arm label
Active Acupuncture
regimen
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.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00797732-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
outcome key
om-0000
arm key
OG001
arm label
Sham Acupuncture
regimen
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.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00797732-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
outcome key
om-0001
arm key
OG000
arm label
Active Acupuncture
regimen
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.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00797732-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
outcome key
om-0001
arm key
OG001
arm label
Sham Acupuncture
regimen
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.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00797732-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
outcome key
om-0002
arm key
OG000
arm label
Active Acupuncture
regimen
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.
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00797732-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
outcome key
om-0002
arm key
OG001
arm label
Sham Acupuncture
regimen
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.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00797732-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
outcome key
om-0003
arm key
OG000
arm label
Active Acupuncture
regimen
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.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00797732-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
outcome key
om-0003
arm key
OG001
arm label
Sham Acupuncture
regimen
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.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00797732-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
harm key
EG000
source section id
NCT00797732-ae
event group key
EG000
event group label
Active Acupuncture
serious affected
0
serious at risk
21
other affected
1
other at risk
21
frequency threshold
0
collection period
Adverse events were evaluated throughout treatment at each visit up to end of treatment week 20 after CRT.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
harm key
EG001
source section id
NCT00797732-ae
event group key
EG001
event group label
Sham Acupuncture
serious affected
0
serious at risk
21
other affected
0
other at risk
21
frequency threshold
0
collection period
Adverse events were evaluated throughout treatment at each visit up to end of treatment week 20 after CRT.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
qol key
qol-0002
source section id
NCT00797732-om-0002
source outcome index
2
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT)
measure definition
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.
time frame
Assessed at baseline and 6 months post acupuncture which parallels 12 months post-CRT
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The analysis population represents the subset of participants evaluable at baseline and 12 months post CRT/6 months post acupuncture
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma
nct id
NCT00797732
qol key
qol-0003
source section id
NCT00797732-om-0003
source outcome index
3
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
MDADI Scores
measure definition
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.
time frame
Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncture
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The analysis population is comprised of all randomized participants. At each timepoint, a subset of participants were evaluable for quality of life assessment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice