Prospective Measurement of Post-Treatment Lymphedema

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Clinical Oncology Research Development Program
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00495950
First received: July 2, 2007
Last updated: July 22, 2014
Last verified: July 2014
  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.


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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 2016 (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.

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

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Clinical Oncology Research Development Program
Investigators
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, 5-K12-CA088084
Study First Received: July 2, 2007
Last Updated: July 22, 2014
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 August 28, 2014