Blood and Lymph Conditions

All Conditions

Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Lymphedema

Head and Neck Neoplasms

Mouth Neoplasms

Oropharyngeal Neoplasms

Lymphatic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Mouth Diseases

Oral Cancer

Lip and Oral Cavity Cancer

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

Follow -Up Visits

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.

Full CDT

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.

Modified CDT Program

Jan S Lewin, PhD

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.

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.

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

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

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Breast Neoplasms

Respiratory Tract Infections

Breast Cancer Lymphedema

Postoperative Complications

Dermatologic Agents

All Drugs and Chemicals

Emollients

The M6 therapy laser is a robotized multi-target device designed to treat patients suffering pathologies affecting a wide area, and to perform automatic applications.

Multi-waved Locked System Laser

The BioCryo Cold Compression System is a cold therapy pneumatic compression device that safely administers sequential, gradient pneumatic compression and CryoTherapy combined.

Cold Compression therapy

Complete decongestive therapy consists of:

* Meticulous skin care with the use of emollients
* Using short stretch bandages or continuous wearing of a pressure garment
* Manual lymphatic drainage therapy
* Remedial exercises (e.g., aerobic exercise, strength training, and stretching exercises)

complete decongestive therapy

Mohamed H El-Gendy, professor

This study was conducted:

* To investigate the effect of MLS Laser in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.
* To investigate the effect of CCT in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.
* To compare the effect of MLS Laser versus CCT in the management of patients with unilateral BCRL regarding lymphatic flow, volumetric measurement and HRQL assessment.

Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema

Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema: Randomized Controlled Trial

Interpretation of the results of the lymphoscintigraphy and using the contralateral limb as a healthy control with normal lymphatic function can differentiate the lymphatic flow abnormalities into 7 stages

Precise arm volume measurement is capital in the follow-up of breast cancer patients, as an early detection of BCRL can reduce the incidence of irreversible stages

The Lymphedema Life Impact Scale is a lymphedema-specific tool which measures physical (pain, heaviness, tightness, strength...), psychosocial (body image, socializing, intimate relations...) and functional (duties at home, duties at work, recreational activities...) impact upon the patients' lives, the maximum score is 68 while the minimum score is 0, where a higher score indicates a worse outcome.

Cairo University

assistant lecturer

Respiratory Aspiration

Breast Diseases

Skin Diseases

Patients in this group will receive "Complete Decongestive Therapy" for 6 weeks. 1 session each week will be supervised in a clinic. Rest of the sessions will be performed at home.

Patients in this group will receive "Complete Decongestive Therapy" combined with diaphragmatic breathing exercises for 6 weeks. 1 session each week will be supervised in a clinic. Rest of the sessions will be performed at home.

Complete Decongestive Therapy will include manual lymphedema drainage (self) for 20 min everyday, skin care everyday, wearing compression garment or bandages everyday and upper-extremity exercises twice a day.

Complete Decongestive Therapy

"Upper-extremity exercises" component of Complete Decongestive Therapy will be performed combined with diaphragmatic breathing exercises.

Upper extremity exercises combined with diaphragmatic breathing exercises

Alis Kostanoglu, assoc.prof.

Complete decongestive therapy is proven to be effective in reducing lymphedema related symptoms such as swelling and pain. Breathing exercises, on the other hand, may also help managing lymphedema symptoms. Deep breathing creates a pressure change in the abdomen, which creates a vacuum effect in the thoracic cavity and helps to empty the lymphatic vessels. Thus, we aimed to investigate whether addition of diaphragmatic breathing exercises to physical exercise component of complete decongestive therapy provides further benefits on lymphedema volume, pain and quality of life in patients with breast cancer related lymphedema.

Does Inclusion of Diaphragmatic Breathing Exercises in Complete Decongestive Therapy Provide Further Benefits in Patients With Breast Cancer Related Lymphedema

Arm volume will be measured using water displacement method.

Visual analog scale will be used for for quantifying pain.

Quality of life will be evaluated using Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema.

Bezmialem Vakif University

Istanbul Kent University

Izmir Bakircay University

asst. prof.

Neoplasm Metastasis

Facies

A combination of manual lymph drainage , compression bandaging, physical exercise and a skin care regimen

Standard of care is currently observation

Observation

Ashley Mays, MD

This will be a prospective, randomized controlled study of \~60 adult patients who have undergone a laryngectomy, neck dissection, maxillectomy or mandibulectomy surgical procedure for the treatment of head and neck cancer at Our Lady of the Lake Hospital and have been referred by their physician for evaluation of head and neck lymphedema while serving as an inpatient. Consenting patients will be evaluated by certified speech and language pathologists trained to ascertain lymphedema severity using a series of visual and tangible measurements immediately following surgery and randomized into two cohorts, one receiving the complete decongestive therapy regimen and the other not receiving this specific combination treatment for their edema. Facial and neck measurements will be taken at baseline following surgery and at several points prior to and at discharge as well as at the 2 week follow up visit to the clinic. Measurements and overall change/reduction in edema will be compared between the cohorts.

BACKGROUND:

Head and neck lymphedema (HNL) is a common and sometimes debilitating complication of head and neck cancer (HNC) treatment. It occurs when the lymphatic system is either overloaded or damaged and cannot clear the high protein lymphatic fluid within the interstitial tissues. This in turn causes inflammation, connective tissue proliferation and overall functional impairment of the lymph system and bodily extremities. The long-term effects that edema can have in the cranio-facial region are not simply a cosmetic nuisance, but can lead to severe functional and psycho-social issues when affecting the lips, tongue, throat, eyes, mouth and neck. The ability to communicate, swallow, breath and see can be greatly impeded by the lymphatic swelling, which clearly affects the quality of life for many patients. Additional deficits may include dysfunction of the arms and shoulders with reduced cervical range of motion. Although lymphedema is well recognized in patients within the fields of urinary, breast and gynecologic cancer, it has only recently been addressed in the area of head and neck cancer.

The therapeutic management of HNL in HNC patients is a growing topic of research, as this condition pushes to the forefront and crosses over multi-disciplinary departments from otolaryngology to cancer therapy to speech and language therapy and rehabilitation. Historically, the technique of manual lymph drainage (MLD), a series of gentle circular massage strokes applied to the skin to increase lymphatic flow has been used. Decades later, the MLD technique was combined with compression bandaging, physical exercises and a skin care regiment to create a complete decongestive therapy (CDT) in the outpatient setting and is now considered to be best practice for outpatient lymphedema treatment at some institutions. The HNL program at M.D. Anderson Cancer Center has also created a series of formal evaluation and treatment techniques which include patient interviews/survey, visual assessment of the cranio-facial, neck and shoulder areas, functional assessments of communication and swallowing, photography, tape measurements and staging scales of edema to characterize the appearance and severity of the swelling.

Herein, investigators propose to examine the effects of complete decongestive therapy on head and neck cancer patients at Our Lady of the Lake Regional Medical Center who experience post-surgical head and neck lymphedema after total laryngectomy, neck dissection, maxillectomy or mandibulectomy compared to a control cohort. Investigators aim to assess the improvement of patient outcomes through the use of this technique to reduce cranio-facial edema and compare to those who do not receive CDT in an in-patient setting. Our study is novel in that there is minimal data on the effect of CDT in the acute care setting and in the areas of the head and neck, hence contributing to the growing body of knowledge about this therapy in this acute patient population.

OBJECTIVES:

The objective of of this research study is to assess physical improvements in visual, measureable and functional outcomes in head and neck cancer patients with head and neck lymphedema who have undergone Complete Decongestive Therapy (CDT) as a part of in-patient care at Our Lady of the Lake Hospital and compare this to patients in a control group who do not receive CDT.

STUDY DESIGN:

This will be a prospective, randomized controlled study of \~60 adult patients who have undergone a laryngectomy, neck dissection, maxillectomy or mandibulectomy surgical procedure for the treatment of head and neck cancer and have been referred by their physician for evaluation of head and neck lymphedema while admitted to inpatient care at Our Lady of the Lake Regional Medical Center following surgery. Patients will be evaluated by certified speech and language pathologists trained to ascertain lymphedema severity using a series of visual and tangible measurements immediately following surgery. Specific therapies for speech and language performance are provided beginning 24-72 hours post op per standard of care. At the time of speech therapy, patients will be informed and consented at the hospital bedside about this study. Those that agree to participate will be randomized into a CDT treatment arm or a control arm. The CDT therapy arm will be a combination of manual lymph drainage (MLD), tissue compression or kinesio tape bandaging, remedial exercises and a skin care regiment. This therapy will be administered every time the patient is seen by the speech pathologist, which is typically on a daily basis until discharge. Patients who are randomized into the control arm will not receive the specific CDT, but will still receive any speech or language therapy or other medical treatment services that are standard for their care management plan. Cranio-facial measurements will be taken of both cohorts by a blinded measurer prior to therapy and prior to hospital discharge, after several rounds of CDT have been administered to the patient. Those in the non-CDT cohort will be measured at the day of inpatient consult and again on day of discharge. Changes in the measurements will determine if the CDT has a positive effect on the edema symptoms.

One speech pathologist on the study team will perform the CDT or control therapy and will only be aware of the participant's cohort arm at the time of random assignment. A second speech pathologist will be blinded to the cohort arm and will be responsible for taking the cranio facial measurements for all participants.

Patients will be randomized into one of two groups. Group A will receive the CDT during their inpatient stay. Group B will not receive the CDT. The randomization of the patients into these 2 cohorts will be predetermined by pulling 15 permuted blocks of 4 (Ex. AABB, ABAB, BABB, ABBA, etc) pre-drawn by an individual not involved in the therapy. The permuted blocks will be lined up sequentially (Ex. AABBABABBABBABBA.....) and each letter placed in one of 60 envelopes. The speech pathologist assigned to the patient will pull the next envelope in order to determine if the patient will be in Group A (CDT) or Group B (no CDT) post-surgery. The principal investigator and the individual who will perform the measurements will be completely blinded to the patient's cohort assignment and in this way, minimize investigator bias.

A medical chart review will also be conducted to gather additional variables such as age, gender, race and any prior head and neck cancer medical history.

Double Blind randomization of patients and investigator outcome assessor. Patients that agree to participate will be randomized into a CDT treatment arm or a control arm that does not receive CDT. One speech pathologist on the study team will perform the CDT and will only be aware of the participant's cohort arm at the time of random assignment. The second speech pathologist will be blinded to the cohort arm and will be responsible for taking the cranio facial measurements for all participants to minimize investigator bias.

Complete Decongestive Therapy on Head and Neck Lymphedema

The Effects of Complete Decongestive Therapy on Head and Neck Lymphedema in Post-surgical Head and Neck Cancer Patients (Randomized Control Trial)

Data will be de-identified upon collection

2 % percent change of composite facial measurement

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema	NCT00951470	Lymphedema Oropharyngeal C... Head and Neck C... Oral Cancer	Follow -Up Visi... Full CDT Modified CDT Pr...	18 Years -	M.D. Anderson Cancer Center
Efficacy of Multi-waved Locked System Laser Versus Cold Compression Therapy on Breast Cancer-related Lymphoedema	NCT05911854	Lymphedema	Multi-waved Loc... Cold Compressio... complete decong...	18 Years -	Cairo University
Does Inclusion of Diaphragmatic Breathing Exercises in Complete Decongestive Therapy Provide Further Benefits in Patients With Breast Cancer Related Lymphedema	NCT05754346	Lymphedema, Bre... Lymphedema of U...	Complete Decong... Upper extremity...	25 Years - 65 Years	Izmir Bakircay University
Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema	NCT00951470	Lymphedema Oropharyngeal C... Head and Neck C... Oral Cancer	Follow -Up Visi... Full CDT Modified CDT Pr...	18 Years -	M.D. Anderson Cancer Center
Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema	NCT00951470	Lymphedema Oropharyngeal C... Head and Neck C... Oral Cancer	Follow -Up Visi... Full CDT Modified CDT Pr...	18 Years -	M.D. Anderson Cancer Center
Complete Decongestive Therapy on Head and Neck Lymphedema	NCT04045860	Lymphedema of F... Secondary Lymph...	Complete Decong... Observation	18 Years -	Our Lady of the Lake Hospital

Spots Global Cancer Trial Database for complete decongestive therapy