Lymphedema Clinical Trials

Members of our lymphedema groups are always asking “What research is being done on lymphemdema?” Historically, this condition has been a step-child in terms of medical research. Indeed, monies spent on research are minute compared to other conditions, despite the fact that millions of people are afflicted with it.

Listed below are trials that are currently open and need recruits. Links that follow will take you to listings of all lymphedema trials—open and closed—and will take you directly to the NIH page on how to apply for a research grant.

Pat O'Connor

June 7, 2008

Lymphedema Open Studies

Recruiting Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study

Conditions: Breast cancer; lymphedema
Intervention: Device: High risk lymphedema education and device intervention
Inclusion Criteria: Age of 18 years or older, biopsy proven breast cancer with no known metastatic cancer, surgical management of breast cancer with node evaluation to be completed at Johns Hopkins Hospital, ability to speak and read English, willing and able to continue follow-up at Johns Hopkins Avon foundation Breast Center
Exclusion Criteria: Known psychiatric illness, unwillingness to be followed for two years, functional arm deficits, prior radiation therapy to the breast or axilla, any prior diagnosis of cancer except basal cell cancer

Recruiting Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients with Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer

Conditions: Cervical cancer; endometrial cancer; lymphedema; vulvar cancer
Intervention: Procedure: Management of therapy complications
Criteria
- Disease Characteristics:
  - Diagnosis of unilateral lower-extremity lymphedema as a result of surgery, chemotherapy, and/or radiation therapy for cervical, vulvar, or endometrial cancer
  - Prior to acute clinic therapy, the affected limb edema must have been greater than stage I and must have had at least a 10% excess volume over the unaffected limb
  - No clinic therapy for lower-extremity lymphedema for 6 months prior to the start of the patient's acute clinic therapy
  - Must be within 3 years from the completion of therapy for original gynecologic cancer diagnosis
  - At the time of completion of acute clinic therapy, patients must have reached their nadir limb volume for two consecutive measurements each 7-10 days apart
  - No known active or recurrent cancer
- Patient Characteristics:
  - GOG performance status 0-2
  - Not pregnant
  - No history of peripheral vascular disease (venous or arterial), pulmonary edema, congestive heart failure, or chronic renal disease
  - No current diagnosis of deep-vein thrombosis or phlebitis in the affected limb
  - No open wound(s) or active infection of the affected limb
  - No history of chronic lower-extremity lymphoma that predates cancer diagnosis
  - No poorly controlled asthma
- Prior Concurrent Therapy:
  - See Disease Characteristics
  - More than 3 months since prior cancer treatment

Recruiting Education with or without Exercise and Counseling in Preventing Lymphedema in Women with Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection

Conditions: Breast cancer; lymphedema; perioperative/postoperative complications
Interventions: Procedure: Conventional surgery; Procedure: Counseling; Procedure: Educational intervention; Procedure: Exercise intervention; Procedure: Management of therapy complications; Procedure: Quality-of-life assessment
Criteria
- Disease Characteristics:
  - Diagnosis of breast cancer
    - Newly diagnosed disease
    - Stage I-III disease
  - No diagnosed lymphedema
  - Arm circumference ≤ 17 inches
  - Scheduled to undergo axillary node dissection with ≥ 10 nodes removed
    - No sentinel axillary node dissection only
  - Hormone receptor status not specified
- Patient Characteristics:
  - Female
  - Menopausal status not specified
  - No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease that, in the opinion of the investigator, significantly reduces mortality over the next 2 years
  - May not be currently homebound or dependent upon a walker or wheelchair for mobility
  - Able to participate in a mild exercise program
  - No prior history of carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer
    - Patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis
    - Patients with basal cell and squamous cell carcinoma of the skin are eligible
- Prior Concurrent Therapy:
  - See Disease Characteristics
  - No prior double mastectomy with axillary node dissection involving both arms
  - May be enrolled on other treatment trials except surgery trials where one treatment arm involves full axillary node dissection
  - Any type of radiotherapy to the breast or axilla allowed
  - Neoadjuvant treatment for this cancer allowed

Not yet recruiting Prospective Evaluation of Lymphoedema Among Patients with Gynaecological Cancer

Conditions: Benign gynaecological diseases; malignant gynaecological diseases
Inclusion Criteria:
- Patients scheduled for surgery of benign or malignant gynaecological diseases as determined jointly by the surgeon and the patient
- Non-pregnant female patients
- Over 18 years of age at time of surgery
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up
- Patients who are capable of, and have given, informed consent to their participation in the study
Exclusion Criteria:
- Patients with a pacemaker
- Allergies against adhesive electrodes and extensive internal metal plates are ineligible for BIS measurement

Recruiting Trial of Decongestive Lymphatic Therapy for Lymphedema in Women with Breast Cancer "DELTA STUDY"

Conditions: Breast cancer; lymphedema
Intervention: Procedure: Decongestive lymphatic therapy
Inclusion Criteria:
- Women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 15% increase in arm volume over the opposite arm
- Patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization. This is to ensure that scheduling difficulties with daily treatments do not arise. Patients may be currently taking tamoxifen or similar hormonal treatment.
Exclusion Criteria:
- Clinical or radiological evidence of active disease, either local or metastatic
- History of contralateral cancer, axillary surgery, radiation or bilateral arm edema. (Edema volume will be taken as the increase in volume compared to the unaffected arm; previous therapy in the opposite arm will reduce the accuracy of measuring excess volume related to lymphedema.)
- Previous surgery involving nodal dissection or radiotherapy to other major node-bearing areas in the body such as the mediastinum or pelvis. Disruption of lymphatic flow in these potentially alternate routes may be compromised by such interventions. Patients are eligible after a simple hysterectomy (+/- oophorectomy).
- Previously undergone massage therapy for arm edema, or has used compression sleeve within the last month
- Serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow up
- Patients for whom massage is contraindicated, such as those with untreated infections or thromboses in the affected arm
- Unable to commence therapy within 7 days of randomization
- Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol

Recruiting The Impact of Lymphedema on Overall and Local Functioning

Conditions: Lymphedema; breast cancer; quality of life
Inclusion Criteria:
- Women
- 18 years and older
- Completed active treatment for breast cancer at least 6 months previously
- Mentally and physically able
Exclusion Criteria:
- Bilateral breast cancer
- Had bilateral or contralateral breast surgery
- Current infection or lymphangitis in the affected arm
- Prior neuromuscular conditions that would affect local or overall functioning
- Recurrence of breast cancer
- Pre-existing lymphedema
- Medical contraindications to BIS testing
- Contraindications to exercise testing
- Body weight exceeding maximum weight limit for treadmill machine

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Recruiting Predictors of Lymphedema Following Breast Cancer Surgery
Conditions: Breast cancer; lymphedema

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Recruiting Expressive Writing in Improving Quality of Life in Patients with Breast Cancer and Lymphedema
Conditions: Breast cancer; fatigue; lymphedema
Interventions: Procedure: Behavioral intervention; Procedure: Psychosocial assessment and care; Procedure: Quality-of-life assessment

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Not yet recruiting Safety Study of Bevacizumab to Treat Women with a History of Breast Cancer and Suffering from Upper Extremity Lymphedema
Condition: Lymphedema
Intervention: Drug: Bevacizumab

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Recruiting Aquatic Exercise Study for Breast Cancer Patients with Lymphedema
Condition: Lymphedema
Intervention: Behavioral: Exercise

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Recruiting Treatment Trial for Post-Thrombotic Syndrome
Condition: Post Thrombotic Syndrome
Intervention: Other: Complex lymphedema therapy

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Recruiting Self-Care for Lymphedema in Patients with Breast Cancer
Condition: Breast cancer
Interventions: Procedure: Quality-of-life assessment; Procedure: Questionnaire administration; Procedure: Survey administration

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Recruiting Prospective Measurement of Post-Treatment Lymphedema
Condition: Melanoma
Intervention: Behavioral: Questionnaire

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Recruiting A Pilot Study of VEGF Inhibition in Patients with Lymphedema Following Breast Cancer Treatment
Conditions: Breast cancer; lymphedema
Intervention: Drug: Bevacizumab

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Recruiting Comparative Trial in Compression Therapy in Leg Lymphedema
Condition: Leg Lymphedema
Interventions: Other: Regular compression therapy (Trico bandages); Other: New compression therapy (C2L bandages)

Recruiting [Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-Risk Status
Conditions: Breast cancer; lymphedema
Intervention: Device: Flexitouch®

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Recruiting The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer
Conditions: Breast neoplasms; lymphedema
Intervention: Drug: Sodium selenite

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Recruiting Breast Cancer Lymphedema: Role of Insulin Resistance/FOXC2
Conditions: Breast cancer; lymphedema

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Not yet recruiting Image-Guided Radiation Therapy in Treating Patients with Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg
Conditions: Lymphedema; musculoskeletal complications; radiation fibrosis; radiation toxicity; sarcoma
Interventions: Procedure: 3-dimensional conformal radiation therapy; Procedure: Chemotherapy; Procedure: Intensity-modulated radiation therapy

Recruiting Treatment of Lymphedema: Application of the Kinesio Taping
Condition: Lymphedema
Intervention: Device: Low stretch bandage and Kinesio Tape

Recruiting Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms
Condition: Lymphedema
Interventions: Procedure: Manual lymph drainage; Procedure: Combined physiotherapy; Procedure: Compression bandaging

Recruiting Axillary Reverse Mapping
Condition: Cancer of the Breast
Intervention: Procedure: Axillary reverse mapping

Recruiting Immediate Radiotherapy or Observation after Surgery for Melanoma Involving Lymph Nodes
Conditions: Malignant melanoma; lymph node disease
Intervention: Radiation: Radiotherapy

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Recruiting RCT to Investigate If Prophylactic Antibiotics Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg
Condition: Cellulitis/erysipelas of the leg
Interventions: Drug: Penicillin VK; Other: Placebo

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Recruiting Flexitouch® Compression System for Venous Stasis Ulcer
Condition: Venous Stasis Ulcer
Interventions: Procedure: Compression wrapping; Procedure: Flexitouch® compression pump

Recruiting Effect of Albendazole Dose on Treatment of Lymphatic Filariasis
Conditions: Lymphatic filariasis; Brugia Malayi infection
Interventions: Drug: Albendazole; Drug: Diethylcarbamazine

Recruiting Research for Elimination of Lymphatic Filariasis (ICIDR)
Condition: Lymphatic Filariasis

Not yet recruiting Effect of Albendazole Dose on Clearance of Filarial Worms
Conditions: Lymphatic Filariasis; Wuchereria Bancrofti infection
Intervention: Drug: DEC/Albendazole

Not yet recruiting Acupuncture for the Treatment of Chronic Lymphedema

Clinical Trials.gov Lymphedema