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

Trial Summary

What is the purpose of this trial?

This randomized clinical trial aims to compare clinic-based CDT and home-based (a hybrid model) CDT on changes in the severity of lymphedema, symptom burden, functional status, and healthcare utilization in HNC survivors with lymphedema.

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 data supports the effectiveness of the treatment CDT Management for Head and Neck Cancer-Related Lymphedema?

Research shows that complex decongestive therapy (CDT) is effective in reducing swelling in patients with lymphedema, particularly after breast cancer surgery. Studies have found that both professionally administered and self-administered CDT can improve lymphedema and enhance quality of life. ^{1 2 3 4 5}

Is complex decongestive therapy (CDT) safe for humans?

Complex decongestive therapy (CDT) is considered non-invasive, painless, and without side effects, making it generally safe for humans. ^{1 2 3 4 6}

How is CDT different from other treatments for head and neck cancer-related lymphedema?

Complex decongestive therapy (CDT) is unique because it is a non-invasive, painless treatment that combines multiple physical therapy techniques to reduce swelling, and it is already considered the standard treatment for lymphedema in other conditions like breast cancer. Unlike some treatments that may involve medication or surgery, CDT focuses on physical methods to manage lymphedema without side effects. ^{1 2 3 4 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pilot Study: The Effectiveness of Complex Decongestive Therapy for Lymphedema in Palliative Care Patients with Advanced Cancer. [2019]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Long-term effects of complex decongestive therapy in breast cancer patients with arm lymphedema after axillary dissection. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of six-step complex decongestive therapy for treating upper limb lymphedema after breast cancer surgery. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of self-administered complex decongestive therapy on breast cancer-related lymphedema: a single-blind randomized controlled trial. [2019]

5. China 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Application of complete decongestive therapy after lymphaticovenular anastomosis of the lower limb combined with liposuction-A retrospective study research. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Prospective trial of complete decongestive therapy for upper extremity lymphedema after breast cancer therapy. [2019]