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

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Brief Title

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

Official Title

Lymphedema in Patients With Oral Cavity and Oropharyngeal Cancer: Prevalence, Functional Effects, and Treatment Outcomes

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
      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.
    

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 radiation and/or surgery
      (with or without chemotherapy) for mouth or throat cancer and it has been at least 1 month
      since your last treatment.

      Part 1 of the Study:

      If you choose to participate in Part 1 of this study, you will complete questionnaires. The
      questionnaires ask about your ability to swallow, eat, and speak, and about your quality of
      life, your satisfaction with your body, and any head and neck cancer symptoms. In total, the
      questionnaires should take less than 30 minutes to complete. You will also be asked about any
      symptoms of lymphedema. Your answers will be compared to the answers of patients who do and
      do not have lymphedema.

      If you do not join Part 2 of this study, your participation in this study will be over after
      you complete the questionnaires.

      Screening for Part 2 of the Study:

      If you have head and neck lymphedema, you may also be eligible for Part 2 of the study. You
      will have "screening tests" to help the doctor decide if you are eligible for Part 2 of the
      study:

        -  The answers you provide to a questionnaire during Part 1 of the study will help the
           doctor find out if you may have lymphedema.

        -  Blood (about 1/2 teaspoon) will be drawn to check your thyroid function.

        -  Your doctor will also check your face and neck for signs of lymphedema during your
           regular clinic visit.

      The research staff will discuss the Part 2 screening test results with you, if applicable.
      Signing this consent form does not mean that you will be able to participate in Part 2 of
      this study. If the screening tests show that you are not eligible for Part 2, you will only
      be enrolled in Part 1.

      Part 2 of the Study:

      If you are found to be eligible to take part in Part 2 of this study, you will first meet
      with a certified lymphedema therapist in the Head and Neck Center. During this visit, the
      therapist will perform a lymphedema exam. This involves checking your neck, face, and mouth
      for swelling, and looking at your skin to check for any open wounds or infection. The
      therapist will also interview you about how well you are able to swallow, eat, speak, and
      perform other normal activities of daily living (performance status). This visit should last
      about 1 hour.

      All Part 2 participants will be offered CDT. It will be your choice if you would like to
      receive a "full" CDT program or a "modified" CDT program. You may also choose to decline both
      of these CDT options and stay on study for follow-up.

      CDT has 4 steps that are designed to help the lymph fluids flow:

        -  Soft tissue of the face and neck is gently massaged, from inside or outside the mouth.
           This lasts for about 30-45 minutes.

        -  Bandages are placed on the face and neck in order to apply gentle pressure to the
           affected areas. The bandages stay in place for about 2-3 hours, before and/or after the
           massage.

        -  The face and neck muscles are exercised a certain way for about 15 minutes or less,
           while the bandages are in place.

        -  The face and neck is washed a certain way for about 5 minutes or less.

      All 4 steps are done in both the full and modified CDT programs. The difference between the
      full and modified programs is that the full program includes 10 CDT sessions at the clinic,
      in addition to a self-managed CDT program at home. Otherwise, the 4 steps of CDT are the same
      in both the clinic sessions and home sessions.

      Full CDT Program:

      If you choose to receive the full CDT program, you will come to the clinic and receive CDT as
      described above, Monday through Friday for 2 weeks of intensive outpatient therapy. The CDT
      will be done by the lymphedema therapist. Each session will last about 1 hour.

      During your last 2 treatment visits (Visits 9 and 10), you will be taught how to do the CDT
      steps at home. You will then perform the CDT steps at home, every day for the next 3 months.

      Modified CDT Program:

      If you choose to receive the modified CDT program, you will come to the clinic for 1-2
      training sessions taught by the lymphedema therapist. Each training session will last about 1
      hour, and you will be taught how to do the CDT steps at home. You will then perform the CDT
      steps at home, every day for the next 3 months.

      Option for No CDT:

      If you decline both study treatment options, you will not receive CDT. You will stay on study
      to receive follow-up as described below.

      Follow-Up in Part 2 of the Study:

      All Part 2 study participants will have 3 follow-up visits. If you received the full or
      modified CDT program, the visits will be at 1, 3, and 6 months after your first lymphedema
      training session. If you declined the CDT, the visits will be at 1, 3, and 6 months after
      your study interview.

      At these visits, you will complete the same questionnaires as you did for screening in Part 1
      of the study. You will also have a lymphedema exam and interview by the lymphedema therapist,
      like you did at the beginning of Part 2 of the study.

      If you received the full or modified CDT program, a study staff member will also call you at
      2, 6, and 9 weeks after your first lymphedema training session, to ask how the home CDT
      program is going.

      Length of Part 2:

      If you are in Part 2, your participation in this study will be over after your 6-month
      follow-up visit.

      This is an investigational study. CDT is commonly used to treat all types of lymphedema,
      including head and neck lymphedema. This study (Part 2) is designed to collect more data on
      whether CDT can help to control head and neck lymphedema and its symptoms. Part 1 is also
      designed to collect data related to head and neck lymphedema.

      Up to 500 patients will take part in this study. All will be enrolled at M. D. Anderson.
    


Study Type

Interventional


Primary Outcome

Head & Neck Lymphedema Occurence


Condition

Lymphedema

Intervention

Follow -Up Visits

Study Arms / Comparison Groups

 No CDT
Description:  CDT=complete decongestive therapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

0

Start Date

October 2012


Primary Completion Date

October 2016

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jan S Lewin, PhD, , 



Administrative Informations


NCT ID

NCT00951470

Organization ID

2009-0363


Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center


Study Sponsor

Jan S Lewin, PhD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

September 2012