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

History of Changes

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
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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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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

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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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

No publications provided

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

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