Prospective Measurement of Post-Treatment Lymphedema

November 23, 2016 updated by: M.D. Anderson Cancer Center

Prospective Measurement of Post-Treatment Lymphedema in Patients With Melanoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study participants with a confirmed diagnosis (M.D. Anderson pathology) of invasive cutaneous melanoma (stages I-III).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of incidences of lymphedema following surgical treatment of stage I, II, and III cutaneous malignant melanoma
Time Frame: 30 Month Period
30 Month Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)
Clinical Oncology Research Development Program

Investigators

  • Principal Investigator: Janice N. Cormier, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

July 2, 2007

First Submitted That Met QC Criteria

July 2, 2007

First Posted (Estimate)

July 3, 2007

Study Record Updates

Last Update Posted (Estimate)

November 25, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-0787
  • 5K12CA088084 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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