Prospective Measurement of Post-Treatment Lymphedema
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Purpose
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.
Objectives:
Primary Objective:
The primary objective is to estimate the incidence of lymphedema (LE), over time following the surgical treatment of stage I, II, and III cutaneous malignant melanoma.
Secondary Objectives:
Beginning at pre-op with follow-up over 30 months, we will examine how changes in LE affect quality of life (QOL) and physical function.
We will conduct pilot testing and validation of the Coping Efficacy with Lymphedema (CEL) questionnaire, the Lymphedema and Melanoma Questionnaire (LEMEQ), and the Lymphedema Interference Questionnaire (LIQ).
| Condition | Intervention |
|---|---|
|
Melanoma |
Behavioral: Questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Prospective Measurement of Post-Treatment Lymphedema in Patients With Melanoma |
- Number of incidences of lymphedema following surgical treatment of stage I, II, and III cutaneous malignant melanoma [ Time Frame: 30 Month Period ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | May 2006 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Questionnaire |
Behavioral: Questionnaire
Questionnaires relating to symptoms experienced during and following standard cancer treatment.
Other Name: Survey
|
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.
This is an investigational study. About 250 patients will take part in this study. All patients will be enrolled at MD Anderson.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study participants with a confirmed diagnosis (M.D. Anderson pathology) of invasive cutaneous melanoma (stages I-III).
Inclusion Criteria:
- 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.
- Prior to surgical treatment
- Patients who can knowledgeably and voluntarily provide an informed consent to participate. The informed consent will be signed and dated.
- Fluent in English.
- At least 18 years of age.
Exclusion Criteria:
- Patients with a prior history of lymphedema or melanoma prior to treatment.
- Patients who are unable to consent due to other medical illnesses or disorientation to person, place or time.
- Patients with known distant metastatic disease (Stage IV).
- Patients with implanted device (pace maker), orthopedic implants, and metal frames.
- Presence of concurrent malignancy that requires active treatment, such as chemotherapy or biotherapy, prior to enrollment.
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Janice N. Cormier, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00495950 History of Changes |
| Other Study ID Numbers: | 2004-0787 |
| Study First Received: | July 2, 2007 |
| Last Updated: | November 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Melanoma Lymphedema Limb Swelling Questionnaire |
Quality of Life Physical Function Survey |
Additional relevant MeSH terms:
|
Lymphedema Melanoma Lymphatic Diseases Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 22, 2013