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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00828516
First received: January 23, 2009
Last updated: December 7, 2012
Last verified: December 2012
Results First Received: November 9, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Head and Neck Cancer
Lymphedema
Intervention: Other: Acupuncture and moxibustion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment: June 2008 though May 2009. Participants recruited via the Mount Vernon Hospital Lymphoedema Service.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Clinical Phase 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.

Participant Flow for 2 periods

Period 1:   Clinical Phase: Series 1
    Clinical Phase  
STARTED     35  
COMPLETED     33  
NOT COMPLETED     2  
Withdrawal by Subject                 2  

Period 2:   Clinical Phase: Series 2
    Clinical Phase  
STARTED     30  
COMPLETED     30  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Clinical Phase Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment

Baseline Measures
    Clinical Phase  
Number of Participants  
[units: participants]
  35  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     29  
>=65 years     6  
Age  
[units: years]
Mean ± Standard Deviation
  57.5  ± 9.3  
Gender  
[units: participants]
 
Female     30  
Male     5  
Region of Enrollment  
[units: participants]
 
United Kingdom     35  



  Outcome Measures
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1.  Primary:   Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)   [ Time Frame: Before 7th acupuncture treatment ]

2.  Primary:   Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile   [ Time Frame: Before the 13th acupuncture treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Beverley de Valois
Organization: Lynda Jackson Macmillan Centre
phone: +44(0)1923-844456
e-mail: beverley.devalois@nhs.net


Publications of Results:
de Valois B, Young T, Melsome E (2012) Assessing the feasibility of using acupuncture and moxibustion to improve quality of life for cancer survivors with upper body lymphoedema. European Journal of Oncology Nursing. 16:301-309


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, EU-20903
Study First Received: January 23, 2009
Results First Received: November 9, 2012
Last Updated: December 7, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: National Institute for Health Research