Using Traditional Acupuncture in the Management of Cancer... | NCT00828516 | Trialant
NCT00828516
Sponsor
East and North Hertfordshire NHS Trust
Status
Completed
Last Update Posted
Jan 17, 2013Estimated
Enrollment
56Actual
Phase
Not Applicable
Conditions
Breast Cancer
Head and Neck Cancer
Lymphedema
Interventions
Acupuncture and moxibustion
Countries
United Kingdom
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00828516
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000632850
Secondary IDs
ID
Type
Description
Link
LJMC-AMWELL-SL
Other Grant/Funding Number
NIHR RISC PB-PG-0407-10086
EU-20903
Brief Title
Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema
Official Title
Using Acupuncture and Moxibustion to Promote Wellbeing and Improve Quality of Life for Patients With Upper Body Lymphoedema Secondary to Cancer Treatment
Acronym
AMWELL-SL
Organization
East and North Hertfordshire NHS TrustOTHER_GOV
Status Module
Record Verification Date
Dec 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2008
Primary Completion Date
Sep 2009Actual
Completion Date
Dec 2009Actual
First Submitted Date
Jan 23, 2009
First Submission Date that Met QC Criteria
Jan 23, 2009
First Posted Date
Jan 26, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 9, 2012
Results First Submitted that Met QC Criteria
Dec 7, 2012
Results First Posted Date
Jan 17, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 7, 2012
Last Update Posted Date
Jan 17, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Beverley de Valois PhD LicAc FBAcC, Research Acupuncturist, East and North Hertfordshire NHS TrustPrincipal Investigator
Lead Sponsor
East and North Hertfordshire NHS TrustOTHER_GOV
Collaborators
Name
Class
Mount Vernon Cancer Centre at Mount Vernon Hospital
OTHER
International Lymphoedema Framework
UNKNOWN
Lymphoedema Support Network
UNKNOWN
University of Exeter
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RATIONALE: Acupuncture and moxibustion may improve well-being and quality of life in patients with lymphedema caused by breast cancer or head, neck, and throat cancer.
PURPOSE: This clinical trial is studying how well acupuncture given together with moxibustion works in improving well-being and quality of life in patients with breast cancer or head, neck, and throat cancer who are undergoing standard treatment for lymphedema.
Detailed Description
OBJECTIVES:
To test the acupuncture and moxibustion treatment strategies to obtain a first measure of response for the approach(es) used in patients with breast cancer or head, neck, and throat cancer undergoing standard treatment for secondary lymphedema.
To assess whether this treatment is an acceptable intervention to cancer patients with secondary lymphedema and to their health care professionals.
To disseminate the data to begin to build the evidence base for using this treatment in the management of lymphedema.
OUTLINE: Patients undergo acupuncture and moxibustion therapy once weekly for 7 treatment (Series 1). After completion of therapy, patients may choose to continue treatment for an additional 6 treatments (Series 2).
Patients complete a set of 4 questionnaires (i.e., sociodemographic, Short-Form-36, Positive and Negative Affect Scale (PANAS), and Measure Yourself Medical Outcome Profile (MYMOP)) at the first treatment and then periodically during study. Patients also complete a series of follow-up questionnaires designed to elicit feedback about their acupuncture experience.
After completion of study treatment, patients are followed at 1 and 3 months.
Conditions Module
Conditions
Breast Cancer
Head and Neck Cancer
Lymphedema
Keywords
lymphedema
male breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
recurrent breast cancer
recurrent squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage I squamous cell carcinoma of the larynx
stage I verrucous carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage II verrucous carcinoma of the larynx
recurrent adenoid cystic carcinoma of the oral cavity
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
56Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Usual treatment plus acupuncture
Experimental
Acupuncture and moxibustion, individualised according to participant priorities, delivered once weekly for 7 treatments (Series 1) followed by 6 treatments (Series 2) if participant wishes to continue treatment
Other: Acupuncture and moxibustion
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Acupuncture and moxibustion
Other
Acupuncture is a form of traditional east Asian medicine that uses needles inserted superficially under the skin to stimulate sites on the body known as acupuncture points. Traditional practice encompasses moxibustion, the application of heat (usually from the smouldering herb artemisia vulgaris or mugwort) to stimulate the points by warming them.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)
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.
Before 7th acupuncture treatment
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile
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.
Before the 13th acupuncture treatment
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
INCLUSION CRITERIA:
male or female patients with either breast or head and neck cancer
diagnosis of mild to moderate uncomplicated lymphoedema
age 18 or over
under the care of the lymphoedema service for at leas:
two months (head and neck cancer patients)
three months (breast cancer patients)
no active cancer disease
at least 3 months since prior active cancer treatment (surgery, radiotherapy, chemotherapy, intravenous treatment)
more than 6 months since prior acupuncture treatment
concurrent adjuvant hormonal therapy allowed
concurrent anti-depressant medication allowed provided there has been no change in prescription or dosing within the past 3 months and patient intends to remain on the medication for the duration of study treatment and follow-up
Able to understand and communicate in English
Able to travel to the Lynda Jackson Macmillan Centre for treatment
Able to attend treatment once weekly for at least 7 consecutive weeks
Able to complete outcome measures
EXCLUSION CRITERIA:
bilateral breast cancer
advanced cancer disease
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Beverley de Valois, PhD LicAc
Lynda Jackson Macmillan Centre at Mount Vernon Hospital
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Lynda Jackson Macmillan Centre at Mount Vernon Cancer Centre
Northwood
HA6 2RN
United Kingdom
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Background
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.
de Valois BA, Young TE, Melsome E. Assessing the feasibility of using acupuncture and moxibustion to improve quality of life for cancer survivors with upper body lymphoedema. Eur J Oncol Nurs. 2012 Jul;16(3):301-9. doi: 10.1016/j.ejon.2011.07.005. Epub 2011 Sep 13.
Result
de Valois B, Young T, Melsome E (2011) Acupuncture in lymphoedema management: a feasibility study. Journal of Lymphoedema. 6(2) 20-31.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Recruitment: June 2008 though May 2009. Participants recruited via the Mount Vernon Hospital Lymphoedema Service.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
Periods
Title
Milestones
Reasons Not Completed
Clinical Phase: Series 1
Type
Comment
Milestone Data
STARTED
FG00035 subjects
COMPLETED
FG00033 subjects
NOT COMPLETED
FG0002 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
Clinical Phase: Series 2
Type
Comment
Milestone Data
STARTED
FG00030 subjects
COMPLETED
FG00030 subjects
NOT COMPLETED
FG000
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Clinical Phase
Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)
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.
All participants completing 6 acupuncture treatments were analysed
Posted
Mean
Standard Deviation
units on a scale
Before 7th acupuncture treatment
ID
Title
Description
OG000
Usual Care Plus Traditional Acupuncture
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
Adverse Events Module
Frequency Threshold
0
Time Frame
6 months
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Usual Care Plus Traditional Acupuncture
Serious Adverse Events
Not provided
Other Adverse Events
Not provided
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
Yes
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Dr Beverley de Valois
Lynda Jackson Macmillan Centre
+44(0)1923-844456
beverley.devalois@nhs.net
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D001943
Breast Neoplasms
D006258
Head and Neck Neoplasms
D008209
Lymphedema
D018567
Breast Neoplasms, Male
D000077195
Squamous Cell Carcinoma of Head and Neck
D018304
Esthesioneuroblastoma, Olfactory
D012468
Salivary Gland Neoplasms
D014062
Tongue Neoplasms
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D009369
Neoplasms
D001941
Breast Diseases
D012871
Skin Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D015670
Acupuncture Therapy
D009071
Moxibustion
Ancestor Terms
ID
Term
D000529
Complementary Therapies
D013812
Therapeutics
Browse Leaves
Not provided
Browse Branches
Not provided
OTHER
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent verrucous carcinoma of the oral cavity
stage I adenoid cystic carcinoma of the oral cavity
stage I mucoepidermoid carcinoma of the oral cavity
stage I verrucous carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage II mucoepidermoid carcinoma of the oral cavity
stage II verrucous carcinoma of the oral cavity
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
recurrent basal cell carcinoma of the lip
recurrent squamous cell carcinoma of the lip and oral cavity
stage I basal cell carcinoma of the lip
stage II basal cell carcinoma of the lip
recurrent metastatic squamous neck cancer with occult primary
recurrent lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage I lymphoepithelioma of the nasopharynx
stage I squamous cell carcinoma of the nasopharynx
stage II lymphoepithelioma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx
recurrent lymphoepithelioma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage I lymphoepithelioma of the oropharynx
stage I squamous cell carcinoma of the oropharynx
stage II lymphoepithelioma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage I inverted papilloma of the paranasal sinus and nasal cavity
stage I midline lethal granuloma of the paranasal sinus and nasal cavity
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage II inverted papilloma of the paranasal sinus and nasal cavity
stage II midline lethal granuloma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
low-grade salivary gland mucoepidermoid carcinoma
recurrent salivary gland cancer
salivary gland acinic cell tumor
salivary gland adenocarcinoma
salivary gland adenoid cystic carcinoma
salivary gland anaplastic carcinoma
salivary gland malignant mixed cell type tumor
salivary gland poorly differentiated carcinoma
salivary gland squamous cell carcinoma
stage I salivary gland cancer
stage II salivary gland cancer
tongue cancer
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Supportive Care
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Usual treatment plus acupuncture
0 subjects
35
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
Between 18 and 65 years
BG00029
>=65 years
BG0006
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00057.5± 9.3
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00030
Male
BG0005
Region of Enrollment
Number
participants
Title
Denominators
Categories
United Kingdom
Title
Measurements
BG00035
Units
Counts
Participants
OG00032
Title
Denominators
Categories
Title
Measurements
OG0001.51± 0.96
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
There will be no improvement in MYMOP profile score after 6 acupuncture treatments.
t-test, 2 sided
<0.001
This was not adjusted for multiple comparisons
Mean Difference (Final Values)
1.51
Standard Deviation
0.96
95
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.
No
Superiority or Other
Primary
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile
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.
This was the number of participants who continued to, and completed, Series 2 of the treatments
Posted
Mean
Standard Deviation
units on a scale
Before the 13th acupuncture treatment
ID
Title
Description
OG000
Usual Care Plus Traditional Acupuncture
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
Units
Counts
Participants
OG00030
Title
Denominators
Categories
Title
Measurements
OG0001.32± 0.94
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
t-test, 2 sided
<0.001
There will be no improvement in MYMOP profile score after 12 treatments
Mean Difference (Final Values)
1.32
Standard Deviation
0.94
95
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.