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Prospective Measurement of Post-Treatment Lymphedema

NCT ID: NCT00495950

Last Updated: 2016-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Melanoma

Keywords

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Melanoma Lymphedema Limb Swelling Questionnaire Quality of Life Physical Function Survey

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Questionnaire

Questionnaire

Intervention Type BEHAVIORAL

Questionnaires relating to symptoms experienced during and following standard cancer treatment.

Interventions

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Questionnaire

Questionnaires relating to symptoms experienced during and following standard cancer treatment.

Intervention Type BEHAVIORAL

Other Intervention Names

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Survey

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Oncology Research Development Program

UNKNOWN

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janice N. Cormier, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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5K12CA088084

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2004-0787

Identifier Type: -

Identifier Source: org_study_id