CDT Management for Head and Neck Cancer-Related Lymphedema

Recruiting at 6 trial locations

Overseen By Alicia Steinmetz, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Active infection, Carotid artery occlusion, Severe lymphedema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of Complete Decongestive Therapy (CDT) can assist individuals with lymphedema, which is swelling caused by a buildup of lymph fluid, following treatment for head and neck cancer. It compares clinic-based CDT with home-based CDT to determine which method better reduces swelling, eases symptoms, and enhances daily life. Suitable participants have undergone head and neck cancer treatment in the past two years, have lymphedema, and can perform self-therapy at home using an internet-connected device. As an unphased trial, this study provides a unique opportunity to contribute to understanding effective lymphedema treatments and improve the quality of life for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that these CDT methods are safe for managing lymphedema in head and neck cancer survivors?

Studies have shown that Complete Decongestive Therapy (CDT) is generally safe for people with head and neck cancer. Research involving 733 patients found that 60% improved after receiving CDT, suggesting the treatment is well-tolerated. Another study examined home-based CDT in socially vulnerable groups and found it both feasible and effective. These findings indicate that both clinic-based and home-based CDT options are safe and manageable for patients. While no treatment is without risks, these studies provide encouraging evidence about the safety of CDT for managing lymphedema in head and neck cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these new approaches to managing head and neck cancer-related lymphedema because they offer flexible treatment options that could fit better into patients' lifestyles. Unlike the traditional clinic-based Complete Decongestive Therapy (CDT) that requires frequent visits, the home-based and hybrid models provide more convenience, allowing patients to manage their condition effectively from home. This flexibility could lead to better adherence to treatment, potentially improving outcomes for patients who struggle with regular clinic visits. Additionally, by comparing these variations, researchers hope to determine which method is most effective and patient-friendly, potentially transforming the standard of care.

What evidence suggests that this trial's treatments could be effective for head and neck cancer-related lymphedema?

This trial will compare Clinic-Based Lymphedema Therapy with Home-Based (a hybrid model) Lymphedema Therapy for managing head and neck cancer-related lymphedema. Studies have shown that Complete Decongestive Therapy (CDT) effectively treats lymphedema in patients who have had head and neck cancer, with about 60% of patients experiencing symptom improvement. Home-based CDT is also effective; research indicates it can be successfully performed at home and helps those who can't easily visit a clinic. Both clinic-based and home-based methods reduce swelling and improve function in people with head and neck lymphedema. These therapies offer promising options for managing symptoms and enhancing the quality of life for survivors. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have head and neck lymphedema within 24 months after cancer treatment. They must be referred by their oncology providers, able to do self-manual lymph drainage, and have internet access plus a digital device at home. It's not for those with active infections in the area, carotid artery disease, or very severe lymphedema.

Inclusion Criteria

It has been 2 years or less since my head and neck cancer treatment.

I can perform lymphatic drainage on myself.

I have been diagnosed with head and neck lymphedema and referred by a cancer specialist.

Exclusion Criteria

I have severe swelling due to lymphedema.

I have had carotid artery disease.

I have no conditions that would make lymphedema therapy unsafe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive clinic-based or home-based CDT for lymphedema management

6 weeks

Follow-up

Participants are monitored for changes in lymphedema severity, symptom burden, and functional status

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Clinic-based CDT
• Home-based (a hybrid model) CDT
• Home-based CDT

Trial Overview The study compares two treatments for managing lymphedema: one where patients go to a clinic (Clinic-based CDT) and another they can do at home using a hybrid model (Home-based CDT). The goal is to see which method better reduces swelling severity, symptoms, impacts on daily life, and healthcare needs.

How Is the Trial Designed?

Group I: Clinic-Based Lymphedema Therapy Active Control 1 Intervention

Group II: Home-Based (a hybrid model) Lymphedema Therapy Active Control 1 Intervention

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A novel model of complex decongestive therapy (CDT) using a mobile application significantly reduced arm volume in breast cancer survivors with lymphedema, showing a decrease from 30.72% to 16.67% over three months.

Patients reported significant improvements in lymphedema symptoms and quality of life, with notable enhancements in general health and vitality scores after three months of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-administration of complex decongestive therapy facilitated by the mobile application WeChat improves lymphedema and quality of life in breast cancer survivors: an observational study. Liang, X., You, M., Wen, C., et al.[2022]

A study involving 55 patients who underwent lymphaticovenular anastomosis (LVA) combined with liposuction showed that adherence to complete decongestive therapy (CDT) significantly improved lymphedema symptoms and quality of life over 12 months.

Patients who adhered to CDT (Group B) experienced greater reductions in lymphedema severity and better health outcomes compared to those who did not adhere (Group A), highlighting the importance of ongoing CDT after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of complete decongestive therapy after lymphaticovenular anastomosis of the lower limb combined with liposuction-A retrospective study research. Zhou, X., Ma, G., Qi, X., et al.[2023]

Complex decongestive therapy (CDT) significantly reduced limb volume in advanced cancer patients with lymphedema, with notable improvements observed after three and six treatments, indicating its efficacy in this population.

Patients reported enhanced quality of life, including better limb function and reduced pain, alongside improvements in skin quality, suggesting that CDT can positively impact both physical and emotional well-being in palliative care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study: The Effectiveness of Complex Decongestive Therapy for Lymphedema in Palliative Care Patients with Advanced Cancer. Cobbe, S., Nugent, K., Real, S.[2019]

A 1-month training course for women to perform self-administered complex decongestive therapy (saCDT) significantly improved pain and arm asymmetry in breast cancer-related lymphedema (BCRL) patients compared to usual care, with only one participant worsening after 6 months.

The experimental group showed a median pain reduction of 2 points and an 8% decrease in arm volume, demonstrating that saCDT can effectively maintain and enhance the benefits of traditional CDT in managing BCRL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of self-administered complex decongestive therapy on breast cancer-related lymphedema: a single-blind randomized controlled trial. Ligabue, MB., Campanini, I., Veroni, P., et al.[2019]

Complete decongestive therapy (CDT) effectively reduces limb girth and volume in patients with lymphedema, with significant improvements observed after 2-4 weeks of treatment, leading to decreased pain levels.

While quality of life improvements were noted, they were not statistically significant; however, patients reported a consistent increase in quality of life throughout the treatment and follow-up period, with many experiencing no pain by the end of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective trial of complete decongestive therapy for upper extremity lymphedema after breast cancer therapy. Mondry, TE., Riffenburgh, RH., Johnstone, PA.[2019]

A six-step complex decongestive therapy (CDT) involving a foam granule bandage and air wave pressure therapy was found to be more effective than the conventional four-step CDT in reducing upper extremity lymphedema in 100 patients after breast cancer surgery.

Patients receiving the six-step CDT reported significantly reduced tightness and swelling in their limbs, indicating improved lymphatic circulation and overall quality of life after 20 treatment sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of six-step complex decongestive therapy for treating upper limb lymphedema after breast cancer surgery. Zhang, HZ., Zhong, QL., Zhang, HT., et al.[2022]

In a study of 57 breast cancer patients with lymphedema, complex decongestive therapy (CDT) significantly reduced arm swelling in those with higher initial edema (PEV≥20%) and maintained this reduction for 24 months.

Patients with lower initial edema (PEV<20%) did not experience significant changes in swelling, but their condition did not worsen, indicating that CDT can help prevent progression in less severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of complex decongestive therapy in breast cancer patients with arm lymphedema after axillary dissection. Hwang, JM., Hwang, JH., Kim, TW., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04045860

Complete Decongestive Therapy on Head and Neck ... 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 ...

2. archives-pmr.org archives-pmr.org/article/S0003-9993(16)30484-1/fulltext

Cancer-Related Head and Neck Lymphedema 60% (95% CI: 56.2-63.5%) had clinical improvement of HNL at their initial post-treatment assessment a median of 10 weeks (IQR: 6-38) after CDT. HNL results ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4397961/

Lymphedema Outcomes in Patients with Head and Neck ... Treatment response was evaluated in 733 patients after receiving therapy; 439 (60%) improved after complete decongestive therapy. Treatment adherence ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/hed.28265

The Management of Head and Neck Lymphoedema: A ... Most patients underwent Complete Decongestive Therapy (CDT) (69.25%), followed by pneumatic compression garment use (21.28%), with selenium ...

5. withpower.com withpower.com/trial/phase-lymphedema-11-2021-89091

CDT Management for Head and Neck Cancer-Related ... Research shows that complex decongestive therapy (CDT) is effective in reducing swelling in patients with lymphedema, particularly after breast cancer surgery.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0196070924003466

Feasibility and efficacy of home-based lymphedema ... This study evaluates the feasibility and effectiveness of home-based lymphedema therapy in a socially vulnerable patient population.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10147473/

Inpatient Decongestive Therapy for Lymphedema in Acute ... Acute postsurgical inpatient MDT was associated with reduced total composite measurements in patients after head and neck surgery.