Working... Menu

Prospective Measurement of Post-Treatment Lymphedema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00495950
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : November 25, 2016
Clinical Oncology Research Development Program
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this study is to measure the amount of limb swelling (lymphedema) that sometimes occurs after melanoma treatment, and to find out how people feel and react to the diagnosis and treatment of melanoma.

Condition or disease Intervention/treatment
Melanoma Behavioral: Questionnaire

Detailed Description:

If you choose to take part in this study, you will have measurements taken of your arms or legs using a Perometer and a bioimpedance machine. The Perometer is a machine that painlessly measures the fluid in your limb using two-directional infrared lights. These lights are located in the frame of the machine that encircles the arm or leg during the measurement. The bioimpedance is a machine that measures the fluid in your arm or leg by passing a very small current through the body similar to an electrocardiogram (EKG). These very small currents are located in electrodes that are placed on the hands and feet during the measurement. Both machines are able to pick up changes in limb size.

You will also be asked to complete a set of questionnaires relating to any symptoms that you may experience in your limbs and/or trunk (chest, stomach, and hip areas) during and following your standard cancer treatment.

Additional questionnaires, along with your limb measurements, will be done at your regularly-scheduled follow-up clinic visits, 3-6 months, 9-12 months, 15-18 months, 21-24 months and 27- 30 months. You will complete the additional questionnaires using a laptop computer or a hardcopy. The measurements and questionnaires will take 45-60 minutes to complete each time.

Some of the data from this study may be sent to the University of Missouri for analysis. The data that is sent will not have any personal identifiers. Researchers at University of Missouri will not be able to link the data to the protected health information or personal identity of any individual participant.

This is an investigational study. Up to 350 patients will take part in this study. All patients will be enrolled at MD Anderson.

Layout table for study information
Study Type : Observational
Actual Enrollment : 350 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Measurement of Post-Treatment Lymphedema in Patients With Melanoma
Study Start Date : May 2006
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Group/Cohort Intervention/treatment
Questionnaire Behavioral: Questionnaire
Questionnaires relating to symptoms experienced during and following standard cancer treatment.
Other Name: Survey

Primary Outcome Measures :
  1. Number of incidences of lymphedema following surgical treatment of stage I, II, and III cutaneous malignant melanoma [ Time Frame: 30 Month Period ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study participants with a confirmed diagnosis (M.D. Anderson pathology) of invasive cutaneous melanoma (stages I-III).

Inclusion Criteria:

  1. Patients with a confirmed diagnosis (M.D. Anderson pathology) of invasive cutaneous melanoma (stages I-III) will be recruited for participation as they present for their initial clinical evaluation to the University of Texas M.D. Anderson Melanoma and Skin Center.
  2. Prior to surgical treatment
  3. Patients who can knowledgeably and voluntarily provide an informed consent to participate. The informed consent will be signed and dated.
  4. Fluent in English.
  5. At least 18 years of age.

Exclusion Criteria:

  1. Patients with a prior history of lymphedema or melanoma prior to treatment.
  2. Patients who are unable to consent due to other medical illnesses or disorientation to person, place or time.
  3. Patients with known distant metastatic disease (Stage IV).
  4. Patients with implanted device (pace maker), orthopedic implants, and metal frames.
  5. Presence of concurrent malignancy that requires active treatment, such as chemotherapy or biotherapy, prior to enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00495950

Layout table for location information
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Clinical Oncology Research Development Program
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Janice N. Cormier, MD M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00495950     History of Changes
Other Study ID Numbers: 2004-0787
5K12CA088084 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by M.D. Anderson Cancer Center:
Limb Swelling
Quality of Life
Physical Function

Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Lymphatic Diseases