Clinical trial NCT00495950: Prospective Measurement of Post-Treatment Lymphedema
Official title: Prospective Measurement of Post-Treatment Lymphedema in Patients With Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Melanoma
Lymphedema
Limb Swelling
Questionnaire
Quality of Life
Physical Function
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Clinical Oncology Research Development Program
name: National Cancer Institute (NCI)
First posted: 2007-07-03
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants with a confirmed diagnosis (M.D. Anderson pathology) of invasive cutaneous melanoma (stages I-III).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of incidences of lymphedema following surgical treatment of stage I, II, and III cutaneous malignant melanoma
timeFrame: 30 Month Period
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Janice N. Cormier, MD
role: PRINCIPAL_INVESTIGATOR
References: