Prospective Measurement of Post-Treatment Lymphedema - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00495950

Purpose

Primary Objective:

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, examine how changes in LE affect quality of life (QOL) and physical function.
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

Genetics Home Reference related topics: lymphedema-distichiasis syndrome

MedlinePlus related topics: Cancer Edema Lymphedema Melanoma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Prospective Measurement of Post-Treatment Lymphedema in Patients With Melanoma

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To measure the amount of limb swelling (lymphedema) that sometimes occurs after melanoma treatment, [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To find out how people feel and react to the diagnosis and treatment of melanoma. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	250
Study Start Date:	May 2006
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Questionnaire	Behavioral: Questionnaire Questionnaires relating to symptoms experienced during and following standard cancer 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.

This is an investigational study. About 250 patients will take part in this study. All patients will be enrolled at M. D. 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 Population

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

Criteria

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, dated and witnessed.
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) and metal frames.
Presence of concurrent malignancy that requires active treatment prior to enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495950

Contacts

Contact: Janice N. Cormier, MD

713-792-9640

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Janice N. Cormier, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Janice N. Cormier, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Janice N. Cormier, MD/Associate Professor )
Study ID Numbers:	2004-0787
Study First Received:	July 2, 2007
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00495950 History of Changes
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

Study placed in the following topic categories:

Lymphedema
Neuroectodermal Tumors
Lymphatic Diseases
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Quality of Life
Edema
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Lymphedema
Neuroectodermal Tumors
Lymphatic Diseases
Neoplasms
Neoplasms by Histologic Type

Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on May 06, 2009