Status:
WITHDRAWN
Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Lymphedema
Oropharyngeal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Objectives: Specific Aim 1: Estimate the prevalence of head and neck lymphedema in patients who have been treated with surgery and/or radiation therapy (± chemotherapy) for oral cavity and oropharyng...
Detailed Description
Screening for Part 1 of the Study: The research staff will review your medical record to find out if you are possibly eligible to join Part 1 of this study. You will be eligible if you have had radia...
Eligibility Criteria
Inclusion
- Adult (greater than or equal to 18 years of age) patients previously treated with definitive surgical resection and/or radiation therapy with or without chemotherapy for oral and/or oropharyngeal cancer who are at least 1 month posttreatment will be eligible for enrollment.
- Patients who meet the above requirement and are also diagnosed with head and neck lymphedema by their physician will be eligible for participation in the prospective phase of the study.
- Patients will be free of acute tissue reactions including oral mucositis, skin breakdown, and fistula prior to inclusion in the prospective phase of the study.
- Patients will have baseline Thyroid Stimulating Hormone testing prior to inclusion in the prospective phase of the study.
Exclusion
- Patients who are actively being treated for head and neck cancer.
- Patients whose cancer treatment was administered with palliative intent.
- Patients with recurrent or second primary head and neck cancer, or persistent disease. Patients who have a persistent neck mass at completion of primary radiotherapy that necessitates salvage neck dissection will be ineligible for enrollment until 1 month (6 weeks) following neck dissection.
- Patients with any of the following contraindications to lymphedema therapy: acute infection, active cancer, congestive heart failure, renal failure, cardiac or pulmonary edema, sensitive carotid sinus, severe carotid blockage, and uncontrolled hypertension.
- Patients with edema related to hypothyroidism.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00951470
Start Date
October 1 2012
Last Update
September 7 2012
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