N/A
Completed N=49
A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment
Head and Neck Cancer · Head and Neck Lymphedema
Source: ClinicalTrials.gov NCT03332160 ↗
Enrolled (actual)
49
Serious AEs
9.3%
Results posted
Aug 2020
Primary outcomePrimary: Fidelity/Adherence Via Subject Diary — 5; 1; 1; 2 Participants
Summary
The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fidelity/Adherence Via Subject Diary |
5; 1; 1; 2; 1; 3 | — |
| PRIMARY Adverse Events |
3; 0; 1; 1; 2; 2 | — |
| PRIMARY Treatment Satisfaction |
5; 16 | — |
| SECONDARY Reduction in Swelling/Inflammation - Endoscopy |
-2.7778; -11.1111 | — |
| SECONDARY Reduction in Swelling/Inflammation - Cytokine Levels |
-836.47; -275.68 | — |
| SECONDARY Reduction in Swelling/Inflammation - Digital Photography |
4.924; -24.308; -7.279; -22.368; -4.4466; -16.5217 | — |
| SECONDARY Reduction in Swelling/Inflammation - Grading of External Lymphedema |
-0.5000; 0.0000 | — |
| SECONDARY Function - Jaw Range of Motion |
4; 1; 18; 17; 2; 1 | — |
| SECONDARY Function - Neck Disability Index |
1.00; 0.00 | — |
| SECONDARY Function - Voice Handicap Index |
0.50; 0.00 | — |
| SECONDARY Function - Cervical and Shoulder Range of Motion |
-1.00; -2.00; 4.00; 1.00; -1.00; -1.00 | — |
| SECONDARY Symptoms - Vanderbilt Head and Neck Symptom Survey |
0.00; 0.00; 0.67; 0.00; -0.06; -0.25 | — |
| SECONDARY Quality of Life - Linear Analog Self-Assessment |
1; 0; 1; 0; 5; 3 | — |
| SECONDARY Symptoms - Lymphedema Symptom Intensity and Distress Survey |
0.00; -2.00; 0.00; 0.00; 0.00; 0.00 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years.
- A previous diagnosis of histologically defined head and neck cancer.
- A diagnosis of head and neck lymphedema.
- Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation.
- Completed cancer treatment with no evidence of active cancer; all post-surgical swelling must be resolved.
- The head and neck garments must fit appropriately. For patients with a tracheostomy, the fit will be assessed to ensure that the garments do not interfere with their tracheostomy.
- The subject must have experienced at least one of the following:
- Completion of phase 1 lymphedema care in the past 8 weeks;
- The inability to participate/complete phase 1 care due to:
- Lack of available therapist/clinic,
- Lack of insurance coverage or funding to support cost of care.
Exclusion Criteria
- Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression).
- Carotid sinus hypersensitivity syndrome.
- Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness).
- Symptomatic bradycardia in the absence of a pacemaker.
- Internal jugular venous thrombosis, acute or within 3 months.
- Increased intracranial pressure or other contraindications to internal or external jugular venous compression.
- Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6-8 weeks post-operative.
- Facial or head and neck dermal metastasis.
- Acute facial infection (e.g., facial or parotid gland abscess).
- Any condition in which increased venous and lymphatic return is undesirable.
- History of pulmonary edema or decompensated congestive heart failure with in six (6) week of enrollment.
- Subject is pregnant or trying to become pregnant.
Data sourced from ClinicalTrials.gov (NCT03332160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.