Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema
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Purpose
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 oropharyngeal cancer.
Compare functional outcomes in patients with and without lymphedema using cross-sectional survey methods.
Specific Aim 2: Evaluate the effect of Complete Decongestive Therapy (CDT) provided in an outpatient setting or a home-based program in reducing lymphedema in patients previously treated with surgery and/or radiation therapy (± chemotherapy) for oral cavity and oropharyngeal cancer at 1, 3 and 6 months follow-up. Patient characteristics, treatment variables, and the health care environment will be analyzed as possible explanatory variables that influence the effect of lymphedema treatment.
Specific Aim 3: Evaluate the effect of lymphedema treatment on symptom burden, self-image, and functional performance status in patients previously treated with surgery and/or radiation therapy (± chemotherapy) for oral cavity and oropharyngeal cancer.
| Condition | Intervention |
|---|---|
|
Lymphedema Oropharyngeal Cancer Head and Neck Cancer Oral Cancer |
Other: Follow -Up Visits Other: Full CDT Other: Modified CDT Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Lymphedema in Patients With Oral Cavity and Oropharyngeal Cancer: Prevalence, Functional Effects, and Treatment Outcomes |
- Head & Neck Lymphedema Occurence [ Time Frame: 30 minutes to complete questionnaires ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | October 2012 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No CDT
CDT=complete decongestive therapy
|
Other: Follow -Up Visits
If CDT is declined, participants will have follow-up visits at 1, 3, and 6 months after study interview.
|
|
Modified CDT Program
CDT=complete decongestive therapy
|
Other: Modified CDT Program
The participant will come to the clinic for 1-2 training sessions taught by the lymphedema therapist. Each training session will last about 1 hour, and the participant will be taught how to do the CDT steps at home. Then, the CDT steps will be performed at home, every day for the next 3 months.
Other Name: complete decongestive therapy
|
|
Full CDT Program
CDT=complete decongestive therapy
|
Other: Full CDT
Monday through Friday visits to the clinic for 2 weeks of intensive outpatient therapy. The CDT will be done by the lymphedema therapist. Each session will last about 1 hour. During the last 2 treatment visits (Visits 9 and 10), the participant will be taught how to do the CDT steps at home. Then, the CDT steps will be performed at home, every day for the next 3 months. Other Name: complete decongestive therapy
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00951470 History of Changes |
| Other Study ID Numbers: | 2009-0363 |
| Study First Received: | July 31, 2009 |
| Last Updated: | September 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Head and neck lymphedema Complete Decongestive Therapy CDT Oral cavity cancer Oropharyngeal cancer |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Lymphedema Mouth Neoplasms Oropharyngeal Neoplasms Neoplasms by Site Neoplasms Lymphatic Diseases |
Mouth Diseases Stomatognathic Diseases Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013