MDACC Study Summary 2004-0787

Study Summary
No. 2004-0787:.......Melanoma......Janice N. Cormier......Surgical Oncology

Study Summary Title



Study Summary Number:	2004-0787

Study Title:	Prospective Measurement of Post-treatment Lymphedema in Patients with Melanoma

Physician

New Patient Referral



Name:	Janice N. Cormier	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Surgical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-9640 Contact us about clinical trials

General Information



Disease Group:	Melanoma	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Patients will return to MDACC for limb measurements 3-6, 9-12, 15-18, 21-24, 27-30 months for a total of 30 months. When possible, we will schedule these 6-month intervals to coincide with regularly scheduled clinic visits.

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	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.

Study Objectives / Outcomes

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 funtion.

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).

Study Status Information



Study Activation / Registration Date:	05/30/2006

IRB Review and Approval Date:	11/17/2004

Study Type:	Behavioral

Recruitment Status:	Open

Projected Accrual:	250

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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, dated and witnessed.

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.

Links

Registration Number: NCT00495950
Study Information on Clinical Trials Registry (clinicaltrials.gov)