Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00951470
First received: July 31, 2009
Last updated: September 5, 2012
Last verified: September 2012
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Patients will have baseline Thyroid Stimulating Hormone testing prior to inclusion in the prospective phase of the study.

Exclusion Criteria:

  1. Patients who are actively being treated for head and neck cancer.
  2. Patients whose cancer treatment was administered with palliative intent.
  3. 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.
  4. 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.
  5. Patients with edema related to hypothyroidism.
  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: NCT00951470

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jan S Lewin, PhD M.D. Anderson Cancer Center
  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:
Lymphedema
Head and Neck Neoplasms
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 July 24, 2014