Using Acupuncture and Moxibustion to Promote Wellbeing and Improve Quality of Life for Patients With Upper Body Lymphoedema Secondary to Cancer Treatment
18 Years
N/A
Both
Breast Cancer, Head and Neck Cancer, Lymphedema
Trial Information
Using Acupuncture and Moxibustion to Promote Wellbeing and Improve Quality of Life for Patients With Upper Body Lymphoedema Secondary to Cancer Treatment
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)
Outcome Description:
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.
Outcome Time Frame:
Before 7th acupuncture treatment
Safety Issue:
No
Principal Investigator
Beverley de Valois, PhD LicAc
Investigator Role:
Principal Investigator
Investigator Affiliation:
Lynda Jackson Macmillan Centre at Mount Vernon Hospital
Authority:
United Kingdom: National Health Service
Study ID:
CDR0000632850
NCT ID:
NCT00828516
Start Date:
April 2008
Completion Date:
December 2009
Related Keywords:
- Breast Cancer
- Head and Neck Cancer
- Lymphedema
- 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
- 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
- Breast Neoplasms
- Head and Neck Neoplasms
- Lymphedema
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