Breast Cancer, Head and Neck Cancer, Lymphedema
Conditions
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
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.
Interventions
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.
Sponsors
Mount Vernon Cancer Centre at Mount Vernon Hospital
International Lymphoedema Framework
Lymphoedema Support Network
University of Exeter
East and North Hertfordshire NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP) | Before 7th acupuncture treatment | 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. |
| Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile | Before the 13th acupuncture treatment | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Recruitment: June 2008 though May 2009. Participants recruited via the Mount Vernon Hospital Lymphoedema Service.
Participants by arm
| Arm | Count |
|---|---|
| Clinical Phase Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Clinical Phase: Series 1 | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Clinical Phase |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age Continuous | 57.5 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment United Kingdom | 35 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
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.
Time frame: Before the 13th acupuncture treatment
Population: This was the number of participants who continued to, and completed, Series 2 of the treatments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Plus Traditional Acupuncture | Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile | 1.32 units on a scale | Standard Deviation 0.94 |
p-value: <0.001t-test, 2 sided
Primary
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.
Time frame: Before 7th acupuncture treatment
Population: All participants completing 6 acupuncture treatments were analysed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Plus Traditional Acupuncture | Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP) | 1.51 units on a scale | Standard Deviation 0.96 |
Comparison: There will be no improvement in MYMOP profile score after 6 acupuncture treatments.p-value: <0.001t-test, 2 sided