Clinical trial NCT00828516: Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema
Official title: Using Acupuncture and Moxibustion to Promote Wellbeing and Improve Quality of Life for Patients With Upper Body Lymphoedema Secondary to Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
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
Lead sponsor: East and North Hertfordshire NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Mount Vernon Cancer Centre at Mount Vernon Hospital
name: International Lymphoedema Framework
name: Lymphoedema Support Network
name: University of Exeter
First posted: 2009-01-26
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: Before 7th acupuncture treatment
measure: Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile
timeFrame: Before the 13th acupuncture treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Northwood
country: United Kingdom
facility: Lynda Jackson Macmillan Centre at Mount Vernon Cancer Centre
Study officials:
affiliation: Lynda Jackson Macmillan Centre at Mount Vernon Hospital
name: Beverley de Valois, PhD LicAc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: de Valois B, Young T, Melsome E (2011) Acupuncture in lymphoedema management: a feasibility study. Journal of Lymphoedema. 6(2) 20-31.