Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-29 @ 6:17 AM
Study NCT ID:
NCT00797732
Status:
COMPLETED
Last Update Posted:
2018-02-13
First Post:
2008-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study of Acupuncture Treatment for Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D007012', 'term': 'Hypopharyngeal Neoplasms'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'weidong_lu@dfci.harvard.edu', 'phone': '617.632.4350', 'title': 'Weidong Lu, PhD, MB, Lic.Ac.', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were evaluated throughout treatment at each visit up to end of treatment week 20 after CRT.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Acupuncture', 'description': '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.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 1, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Acupuncture', 'description': '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.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Outcome Compliance Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Acupuncture', 'description': '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.'}, {'id': 'OG001', 'title': 'Sham Acupuncture', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000', 'lowerLimit': '52.8', 'upperLimit': '91.8'}, {'value': '85.7', 'groupId': 'OG001', 'lowerLimit': '63.6', 'upperLimit': '97.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed at baseline and at 6 months post acupuncture treatment', 'description': '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).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is comprised of all randomized participants.'}, {'type': 'PRIMARY', 'title': 'Treatment Compliance Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Acupuncture', 'description': '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.'}, {'id': 'OG001', 'title': 'Sham Acupuncture', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000', 'lowerLimit': '52.8', 'upperLimit': '91.8'}, {'value': '81.0', 'groupId': 'OG001', 'lowerLimit': '58.1', 'upperLimit': '94.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks)', 'description': 'Treatment compliance rate is the percentage of enrolled participants who completed at least 80% of treatment (10 of 12 acupuncture sessions).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is comprised of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Acupuncture', 'description': '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.'}, {'id': 'OG001', 'title': 'Sham Acupuncture', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '15.6'}, {'value': '13.9', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '21.4'}]}]}], 'analyses': [{'pValue': '.17', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline and 6 months post acupuncture which parallels 12 months post-CRT', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population represents the subset of participants evaluable at baseline and 12 months post CRT/6 months post acupuncture'}, {'type': 'SECONDARY', 'title': 'MDADI Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Acupuncture', 'description': '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.'}, {'id': 'OG001', 'title': 'Sham Acupuncture', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.3', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '69.2', 'spread': '15.5', 'groupId': 'OG001'}]}]}, {'title': '20 weeks post chemoradiation start', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.7', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '77.8', 'spread': '10.9', 'groupId': 'OG001'}]}]}, {'title': '6 months post acupuncture start', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.7', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '79.3', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncture', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is comprised of all randomized participants. At each timepoint, a subset of participants were evaluable for quality of life assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Acupuncture', 'description': '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\\]'}, {'id': 'FG001', 'title': 'Sham Acupuncture', 'description': '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\\]'}, {'id': 'FG002', 'title': 'Screened Non-Randomized', 'description': 'Participants approached in the screening process but ultimately not randomized.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '154'}]}, {'type': 'Evaluable at Baseline', 'comment': 'Evaluable for quality of life assessment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Evaluable at 20 Weeks', 'comment': 'Evaluable for quality of life assessment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Evaluable at 12 Months', 'comment': 'Evaluable for quality of life assessment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '154'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Excluded due to time constraints', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'Refused to Participate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '123'}]}]}], 'recruitmentDetails': 'Patients were screened for potential enrollment from January 2009 through December 2011.', 'preAssignmentDetails': 'Since one primary aim was to assess feasibility as measured by recruitment the screening non-randomized count is included in the participant flow.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Acupuncture', 'description': '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.'}, {'id': 'BG001', 'title': 'Sham Acupuncture', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '59.1', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total IMRT dose (Gy)', 'classes': [{'categories': [{'title': '58 Gy', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '64 GY', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '66 Gy', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '70 Gy', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'IMRT, intensity modulated radiation therapy, dose received', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis population is comprised of all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-16', 'studyFirstSubmitDate': '2008-11-21', 'resultsFirstSubmitDate': '2017-10-03', 'studyFirstSubmitQcDate': '2008-11-21', 'lastUpdatePostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-16', 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcome Compliance Rate', 'timeFrame': 'Assessed at baseline and at 6 months post acupuncture treatment', 'description': '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).'}, {'measure': 'Treatment Compliance Rate', 'timeFrame': 'Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks)', 'description': 'Treatment compliance rate is the percentage of enrolled participants who completed at least 80% of treatment (10 of 12 acupuncture sessions).'}], 'secondaryOutcomes': [{'measure': 'MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT)', 'timeFrame': 'Assessed at baseline and 6 months post acupuncture which parallels 12 months post-CRT', 'description': '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.'}, {'measure': 'MDADI Scores', 'timeFrame': 'Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncture', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['acupuncture', 'dysphagia', 'chemoradiation related effects', 'squamous cell carcinoma of the head and neck', 'nasopharyngeal cancer', 'oropharynx cancer', 'hypopharynx cancer', 'larynx cancer'], 'conditions': ['Carcinomas, Squamous Cell', 'Dysphagia']}, 'referencesModule': {'references': [{'pmid': '22406102', 'type': 'BACKGROUND', 'citation': 'Lu W, Wayne PM, Davis RB, Buring JE, Li H, Goguen LA, Rosenthal DS, Tishler RB, Posner MR, Haddad RI. Acupuncture for dysphagia after chemoradiation in head and neck cancer: rationale and design of a randomized, sham-controlled trial. Contemp Clin Trials. 2012 Jul;33(4):700-11. doi: 10.1016/j.cct.2012.02.017. Epub 2012 Mar 2.'}, {'pmid': '20713374', 'type': 'BACKGROUND', 'citation': 'Lu W, Posner MR, Wayne P, Rosenthal DS, Haddad RI. Acupuncture for dysphagia after chemoradiation therapy in head and neck cancer: a case series report. Integr Cancer Ther. 2010 Sep;9(3):284-90. doi: 10.1177/1534735410378856. Epub 2010 Aug 16.'}, {'pmid': '27511906', 'type': 'BACKGROUND', 'citation': 'Lu W, Wayne PM, Davis RB, Buring JE, Li H, Macklin EA, Lorch JH, Burke E, Haddad TC, Goguen LA, Rosenthal DS, Tishler RB, Posner MR, Haddad RI. Acupuncture for Chemoradiation Therapy-Related Dysphagia in Head and Neck Cancer: A Pilot Randomized Sham-Controlled Trial. Oncologist. 2016 Dec;21(12):1522-1529. doi: 10.1634/theoncologist.2015-0538. Epub 2016 Aug 10.'}, {'pmid': '35998768', 'type': 'DERIVED', 'citation': 'Lu W, Giobbie-Hurder A, Tanasijevic A, Baedorf Kassis S, Park SH, Jeong YJ, Shin IH, Yao C, Jung HJ, Zhu Z, Bao C, Yang EM, Bierer BE, Ligibel JA. Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinated multinational study: Rationale and design of the study protocol. Contemp Clin Trials. 2022 Oct;121:106885. doi: 10.1016/j.cct.2022.106885. Epub 2022 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'The current standard of care for advanced HNC is concurrent chemoradiation therapy (CRT), which has led to increased survival rates, but with significant acute and long-term toxicities. Dysphagia, or difficulty with swallowing, is a common and expected side effect during and following CRT. Dysphagia occurs in up to 50% of patients and significantly impairs the quality of life (QOL) of patients during delivery of and recovery from CRT. Clinical trials evaluating promising and innovative adjunctive approaches that could increase the rate and magnitude of recovery from dysphagia in HNC patients are needed. Acupuncture is a traditional Chinese medical technique that has been found to reduce symptoms and side effects associated with primary cancer therapy. This study evaluated the feasibility of conducting a randomized sham-controlled trial and collected preliminary data on safety and efficacy of acupuncture.', 'detailedDescription': 'AIMS:\n\nAim 1. To assess the feasibility of recruiting and retaining HNC patients with dysphagia into a randomized sham-controlled trial of acupuncture.\n\nAim 2. To collect preliminary data on the efficacy of acupuncture in changing scores of HRQOL in post CRT head and neck cancer patients.\n\nAim 3. (Exploratory) In a subset of HNC subjects treated with both active and sham acupuncture, to collect objective measures on swallowing functions using Videofluoroscopic swallowing study (VFSS); salivary flow production; and plasma Transforming Growth Factor (TGF)-β1, Interleukin 6 (IL-6), Tumor necrosis factor-alpha (TNF-α) and Interleukin 13 levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically proven squamous cell carcinoma of the head and neck (SCCHN) at stage II, III and IV, without evidence of distant metastasis. Stage I disease will also be permitted if the patient is receiving CRT;\n* Primary tumor sites eligible: nasopharyngeal, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be included. Unknown primary squamous cell carcinoma (SCC) in the neck will also be eligible. SCC of the oral cavity will also be eligible with the approval of the treating staff;\n* Receiving chemoradiation;\n* Currently or recently undergoing swallowing therapy program with or without feeding tube use, with or without neck dissection;\n* Age ≥ 18 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* Adequate hematological function: neutrophil count \\>1.0 x109/L, platelet count \\>50x109/L\n* Signed informed consent.\n\nExclusion Criteria\n\nPatients with the following criteria will NOT be eligible for the study:\n\n* Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;\n* Wearing a pacemaker or implantable cardioverter-defibrillator;\n* History of significant neurologic disorder that affects swallowing, including stroke, neurodegenerative disease, advanced dementia, or uncontrolled seizure disorder;\n* Active clinically significant uncontrolled infection;\n* Prior use of acupuncture for dysphagia;'}, 'identificationModule': {'nctId': 'NCT00797732', 'briefTitle': 'A Pilot Study of Acupuncture Treatment for Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Acupuncture for Dysphagia After Chemoradiation Therapy in Head and Neck Cancer Patients: A Pilot Randomized Control Trial', 'orgStudyIdInfo': {'id': '08-169'}, 'secondaryIdInfos': [{'id': 'K01AT004415-01', 'link': 'https://reporter.nih.gov/quickSearch/K01AT004415-01', 'type': 'NIH'}, {'id': 'DFCI-08169', 'type': 'OTHER', 'domain': 'Dana-Farber Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Acupuncture', 'description': '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\\]', 'interventionNames': ['Device: Acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Acupuncture', 'description': '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\\]', 'interventionNames': ['Device: Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'DEVICE', 'armGroupLabels': ['Active Acupuncture', 'Sham Acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Weidong Lu, MB, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard Medical School/Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Weidong Lu', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}