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Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema (AMWELL-SL)

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ClinicalTrials.gov Identifier: NCT00828516
Recruitment Status : Completed
First Posted : January 26, 2009
Results First Posted : January 17, 2013
Last Update Posted : January 17, 2013
Sponsor:
Collaborators:
Mount Vernon Cancer Centre at Mount Vernon Hospital
International Lymphoedema Framework
Lymphoedema Support Network
University of Exeter
Information provided by (Responsible Party):
Beverley de Valois PhD LicAc FBAcC, East and North Hertfordshire NHS Trust

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Breast Cancer
Head and Neck Cancer
Lymphedema
Intervention Other: Acupuncture and moxibustion
Enrollment 56
Recruitment Details Recruitment: June 2008 though May 2009. Participants recruited via the Mount Vernon Hospital Lymphoedema Service.
Pre-assignment Details  
Arm/Group Title Clinical Phase
Hide Arm/Group Description Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment. Acupuncture and moxibustion, individualised according to participant priorities, delivered once weekly for 7 treatments (Series 1) followed by a further 6 treatments (Series 2) if participant wishes to continue treatment.
Period Title: Clinical Phase: Series 1
Started 35
Completed 33
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Period Title: Clinical Phase: Series 2
Started 30
Completed 30
Not Completed 0
Arm/Group Title Clinical Phase
Hide Arm/Group Description Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
  82.9%
>=65 years
6
  17.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
57.5  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
30
  85.7%
Male
5
  14.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 35 participants
35
1.Primary Outcome
Title Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)
Hide Description MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.
Time Frame Before 7th acupuncture treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants completing 6 acupuncture treatments were analysed
Arm/Group Title Usual Care Plus Traditional Acupuncture
Hide Arm/Group Description:
All participants were considered stable and were undergoing maintenance treatment for lymphoedema, and were receiving adjunctive acupuncture treatment to promote wellbeing and improve quality of life
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.51  (0.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Plus Traditional Acupuncture
Comments There will be no improvement in MYMOP profile score after 6 acupuncture treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This was not adjusted for multiple comparisons
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.51
Parameter Dispersion
Type: Standard Deviation
Value: 0.96
Estimation Comments MYMOP uses a 7-point scale, from 0 to 6, with "0" as good as it can be, and "6" as bad as it can be. Higher values represent a worse outcome.
2.Primary Outcome
Title Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile
Hide Description MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.
Time Frame Before the 13th acupuncture treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This was the number of participants who continued to, and completed, Series 2 of the treatments
Arm/Group Title Usual Care Plus Traditional Acupuncture
Hide Arm/Group Description:
All participants were considered stable and were undergoing maintenance treatment for lymphoedema, and were receiving adjunctive acupuncture treatment to promote wellbeing and improve quality of life
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.32  (0.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Plus Traditional Acupuncture
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments There will be no improvement in MYMOP profile score after 12 treatments
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.32
Parameter Dispersion
Type: Standard Deviation
Value: 0.94
Estimation Comments MYMOP uses a 7-point scale, from 0 to 6, with "0" as good as it can be, and "6" as bad as it can be. Higher values represent a worse outcome.
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care Plus Traditional Acupuncture
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Usual Care Plus Traditional Acupuncture
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care Plus Traditional Acupuncture
Affected / at Risk (%)
Total   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Plus Traditional Acupuncture
Affected / at Risk (%)
Total   0/35 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Beverley de Valois
Organization: Lynda Jackson Macmillan Centre
Phone: +44(0)1923-844456
EMail: beverley.devalois@nhs.net
Other Publications:
de Valois B and Peckham R (2011) Treating the person and not the disease: acupuncture in the management of cancer treatment-related lymphoedema. European Journal of Oriental Medicine, 6(6), 37-49.
Layout table for additonal information
Responsible Party: Beverley de Valois PhD LicAc FBAcC, East and North Hertfordshire NHS Trust
ClinicalTrials.gov Identifier: NCT00828516     History of Changes
Other Study ID Numbers: CDR0000632850
LJMC-AMWELL-SL ( Other Grant/Funding Number: NIHR RISC PB-PG-0407-10086 )
EU-20903
First Submitted: January 23, 2009
First Posted: January 26, 2009
Results First Submitted: November 9, 2012
Results First Posted: January 17, 2013
Last Update Posted: January 17, 2013