Breast CancerAMWELL-SLNCT00828516
Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema
A study testing Acupuncture and moxibustion in people with Breast Cancer and Head and Neck Cancer, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Head and Neck Cancer, Lymphedema
- What is being tested?
- Acupuncture and moxibustion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 15Show fewer
- 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
Who cannot join
- bilateral breast cancer
- advanced cancer disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lynda Jackson Macmillan Centre at Mount Vernon Cancer Centre
Northwood, HA6 2RN
About this study
Official title: Using Acupuncture and Moxibustion to Promote Wellbeing and Improve Quality of Life for Patients With Upper Body Lymphoedema Secondary to Cancer Treatment
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.
Read the 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
- Breast Cancer, Head and Neck Cancer, Lymphedema
- Being tested
- Acupuncture and moxibustion
- 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, 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
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Lymphedema, Breast Neoplasms, Male, Squamous Cell Carcinoma of Head and Neck, Esthesioneuroblastoma, Olfactory, Salivary Gland Neoplasms, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and moxibustionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Acupuncture and moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before the 13th acupuncture treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Collaborators
- Mount Vernon Cancer Centre at Mount Vernon Hospital, International Lymphoedema Framework, Lymphoedema Support Network, University of Exeter
- Responsible party
- Principal investigator, Beverley de Valois PhD LicAc FBAcC, East and North Hertfordshire NHS Trust
- Investigators
- Beverley de Valois, PhD LicAc, Principal investigator, Lynda Jackson Macmillan Centre at Mount Vernon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828516
- Sponsor's protocol ID
- CDR0000632850
- Other IDs
- LJMC-AMWELL-SL, EU-20903
- Acronym
- AMWELL-SL
- Status last verified
- Dec 2012
- First submitted
- 23 Jan 2009
- Last updated
- 17 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
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.
PubMed 21917515de Valois B, Young T, Melsome E (2011) Acupuncture in lymphoedema management: a feasibility study. Journal of Lymphoedema. 6(2) 20-31.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Acupuncture and Moxibustion to Promote Wellbeing and Improve Quality of Life for Patients With Upper Body Lymphoedema Secondary to Cancer Treatment
- ClinicalTrials.gov ID
- NCT00828516
- Acronym / sponsor ID
- AMWELL-SL / CDR0000632850
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Collaborators
- Mount Vernon Cancer Centre at Mount Vernon Hospital, International Lymphoedema Framework, Lymphoedema Support Network, University of Exeter
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Jan 2009 (estimated)
- Results
- Posted 17 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual treatment plus acupuncture | Experimental | Other: Acupuncture and moxibustionAcupuncture 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (2 listed)
- bilateral breast cancer
- advanced cancer disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture and moxibustionAcupuncture 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. | Other | Usual treatment plus acupuncture |
Primary outcome
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)
Time frame: Before 7th acupuncture treatment
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.
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile
Time frame: Before the 13th acupuncture treatment
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Backgroundde 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.
- Results publication: PubMed 21917515de 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.
- Results publicationde Valois B, Young T, Melsome E (2011) Acupuncture in lymphoedema management: a feasibility study. Journal of Lymphoedema. 6(2) 20-31.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverley de Valois, PhD LicAc principal investigator
Lynda Jackson Macmillan Centre at Mount Vernon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and moxibustion in people with Breast Cancer and Head and Neck Cancer, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP) (time frame: Before 7th acupuncture treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00828516, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.