Acupuncture and Moxibustion 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 - Full Text View

Sponsor:	Lynda Jackson Macmillan Centre at Mount Vernon Hospital
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00828516

Purpose

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.

Condition	Intervention
Breast Cancer Head and Neck Cancer Lymphedema	Other: questionnaire administration Procedure: acupuncture therapy Procedure: assessment of therapy complications Procedure: management of therapy complications Procedure: naturopathy therapy Procedure: quality-of-life assessment

Study Type:	Interventional
Study Design:	Supportive Care
Official Title:	Using Acupuncture and Moxibustion to Promote Wellbeing and Improve Quality of Life in Patients With Secondary Lymphoedema

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome

MedlinePlus related topics: Acupuncture Breast Cancer Cancer Head and Neck Cancer Lymphedema Salivary Gland Disorders Tonsils and Adenoids

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Acupuncture and moxibustion treatment strategies (Acu/Moxa) in promoting well-being and improving quality of life [ Designated as safety issue: No ]
Acu/Moxa as an acceptable intervention to cancer patients with secondary lymphedema and their health care professionals [ Designated as safety issue: No ]
Evidence base for using Acu/Moxa in management of lymphedema [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

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 weeks. After completion of therapy, patients may choose to continue treatment for an additional 6 weeks.

Patients complete a set of 4 questionnaires (i.e., sociodemographic, Short-Form-36, Positive and Negative Affect Scale, and Measure Your Medical Outcome Profile) 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 week and 1 and 3 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of lymphedema secondary to one of the following:
- Breast cancer, meeting the following criteria:
  - Underwent unilateral surgery only
  - Diagnosis of mild to moderate uncomplicated lymphedema of the arm and/or midline (as assessed by the Macmillan Lymphedema Specialist at Mount Vernon Hospital [MVH])
  - Managed by the Macmillan Lymphedema Specialist at MVH for at least 3 months
- Head, neck, or throat cancer meeting the following criteria:
  - Any head, neck, or throat cancer site and diagnosis
  - Managed by the Macmillan Lymphedema Specialist at MVH for at least 2 months
No active or advanced disease
Cellulitis allowed

PATIENT CHARACTERISTICS:

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 7 consecutive weeks
Able to complete outcome measures

PRIOR CONCURRENT THERAPY:

At least 3 months since prior active cancer treatment (including surgery, radiotherapy, chemotherapy, and 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828516

Locations

United Kingdom
Lynda Jackson Macmillan Centre at Mount Vernon Cancer Centre	Recruiting
Northwood, United Kingdom, HA6 2RN
Contact: Beverley de Valois, PhD, MA, MBAcC 44-1923-844-456

Sponsors and Collaborators

Lynda Jackson Macmillan Centre at Mount Vernon Hospital

Investigators

Principal Investigator:

Beverley de Valois, PhD, MA, MBAcC

Lynda Jackson Macmillan Centre at Mount Vernon Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000632850, LJMC-AMWELL-SL, EU-20903
Study First Received:	January 23, 2009
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00828516 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

lymphedema
male breast cancer
stage I 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
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

Additional relevant MeSH terms:

Lymphedema
Lymphatic Diseases
Neoplasms
Neoplasms by Site

Skin Diseases
Head and Neck Neoplasms
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010