Prospective Measurement of Post-Treatment Lymphedema in Patients With Melanoma
18 Years
N/A
Both
Melanoma
Trial Information
Prospective Measurement of Post-Treatment Lymphedema in Patients With Melanoma
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.
This is an investigational study. About 250 patients will take part in this study. All
patients will be enrolled at MD Anderson.
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Number of incidences of lymphedema following surgical treatment of stage I, II, and III cutaneous malignant melanoma
Outcome Time Frame:
30 Month Period
Safety Issue:
No
Principal Investigator
Janice N. Cormier, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2004-0787
NCT ID:
NCT00495950
Start Date:
May 2006
Completion Date:
Related Keywords:
- Melanoma
- Melanoma
- Lymphedema
- Limb Swelling
- Questionnaire
- Quality of Life
- Physical Function
- Survey
- Lymphedema
- Melanoma
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
