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

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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by National Cancer Institute (NCI).   Recruitment status was  Recruiting

First Received on January 23, 2009.  
Last Updated on February 24, 2011  
History of Changes
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: Primary Purpose: 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:

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:

No publications provided

ClinicalTrials.gov Identifier: NCT00828516    
History of Changes
Other Study ID Numbers: CDR0000632850, LJMC-AMWELL-SL, EU-20903
Study First Received: January 23, 2009
Last Updated: February 24, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):

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
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

Additional relevant MeSH terms:

Breast Neoplasms
Head and Neck Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on August 21, 2012

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