NCT00828516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

January 17, 2013

Completed
Last Updated

January 17, 2013

Status Verified

December 1, 2012

Enrollment Period

1.4 years

First QC Date

January 23, 2009

Results QC Date

November 9, 2012

Last Update Submit

December 7, 2012

Conditions

Breast CancerHead and Neck CancerLymphedema

Keywords

lymphedemamale breast cancerstage IA breast cancerstage IB breast cancerstage II breast cancerrecurrent breast cancerrecurrent squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxstage I squamous cell carcinoma of the larynxstage I verrucous carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage II verrucous carcinoma of the larynxrecurrent adenoid cystic carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent verrucous carcinoma of the oral cavitystage I adenoid cystic carcinoma of the oral cavitystage I mucoepidermoid carcinoma of the oral cavitystage I verrucous carcinoma of the oral cavitystage II adenoid cystic carcinoma of the oral cavitystage II mucoepidermoid carcinoma of the oral cavitystage II verrucous carcinoma of the oral cavitystage I squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the lip and oral cavityrecurrent basal cell carcinoma of the liprecurrent squamous cell carcinoma of the lip and oral cavitystage I basal cell carcinoma of the lipstage II basal cell carcinoma of the liprecurrent metastatic squamous neck cancer with occult primaryrecurrent lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage I lymphoepithelioma of the nasopharynxstage I squamous cell carcinoma of the nasopharynxstage II lymphoepithelioma of the nasopharynxstage II squamous cell carcinoma of the nasopharynxrecurrent lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage I lymphoepithelioma of the oropharynxstage I squamous cell carcinoma of the oropharynxstage II lymphoepithelioma of the oropharynxstage II squamous cell carcinoma of the oropharynxrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent inverted papilloma of the paranasal sinus and nasal cavityrecurrent midline lethal granuloma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavitystage I esthesioneuroblastoma of the paranasal sinus and nasal cavitystage I inverted papilloma of the paranasal sinus and nasal cavitystage I midline lethal granuloma of the paranasal sinus and nasal cavitystage I squamous cell carcinoma of the paranasal sinus and nasal cavitystage II esthesioneuroblastoma of the paranasal sinus and nasal cavitystage II inverted papilloma of the paranasal sinus and nasal cavitystage II midline lethal granuloma of the paranasal sinus and nasal cavitystage II squamous cell carcinoma of the paranasal sinus and nasal cavitylow-grade salivary gland mucoepidermoid carcinomarecurrent salivary gland cancersalivary gland acinic cell tumorsalivary gland adenocarcinomasalivary gland adenoid cystic carcinomasalivary gland anaplastic carcinomasalivary gland malignant mixed cell type tumorsalivary gland poorly differentiated carcinomasalivary gland squamous cell carcinomastage I salivary gland cancerstage II salivary gland cancertongue cancer

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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

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.

Usual treatment plus acupuncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • bilateral breast cancer
  • advanced cancer disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lynda Jackson Macmillan Centre at Mount Vernon Cancer Centre

Northwood, HA6 2RN, United Kingdom

Location

Related Publications (3)

  • 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.

    BACKGROUND

  • 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.

    PMID: 21917515RESULT

  • de Valois B, Young T, Melsome E (2011) Acupuncture in lymphoedema management: a feasibility study. Journal of Lymphoedema. 6(2) 20-31.

    RESULT

MeSH Terms

Conditions

Breast NeoplasmsHead and Neck NeoplasmsLymphedemaBreast Neoplasms, MaleSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactorySalivary Gland NeoplasmsTongue Neoplasms

Interventions

Acupuncture TherapyMoxibustion

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesTongue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Results Point of Contact

Title
Dr Beverley de Valois
Organization
Lynda Jackson Macmillan Centre
beverley.devalois@nhs.net
+44(0)1923-844456

Study Officials

  • Beverley de Valois, PhD LicAc

    Lynda Jackson Macmillan Centre at Mount Vernon Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Acupuncturist

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 26, 2009

Study Start

April 1, 2008

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

January 17, 2013

Results First Posted

January 17, 2013

Record last verified: 2012-12

Locations

GB(1)