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

NCT00951470 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-09-07

No results posted yet for this study

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 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.

Conditions

Interventions

OTHER

Follow -Up Visits

If CDT is declined, participants will have follow-up visits at 1, 3, and 6 months after study interview.

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

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jan S Lewin, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00951470 on ClinicalTrials.gov