Who is sponsoring NCT03332160?

NCT03332160 is sponsored by Tactile Medical.

What condition does NCT03332160 study?

NCT03332160 studies Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Lymphedema.

Is NCT03332160 still recruiting?

NCT03332160 is currently completed. Last updated 6 August 2020.

Are results published for NCT03332160?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-08-06 · How we verify

NCT03332160

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment

Completed NA Results posted Last updated 6 August 2020

What this trial tests

NA trial testing Flexitouch head and neck lymphedema treatment system in Head and Neck Neoplasms in 49 participants. Completed in 31 July 2019.

Timeline

2 January 2018

Primary endpoint
4 June 2019

31 July 2019

Quick facts

Lead sponsor	Tactile Medical
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	49
Start date	2 January 2018
Primary completion	4 June 2019
Estimated completion	31 July 2019
Sites	2 locations across United States

Drugs / interventions tested

Flexitouch head and neck lymphedema treatment system
Standard home lymphedema care

Conditions studied

Head and Neck Neoplasms — all drugs for Head and Neck Neoplasms →
Head and Neck Cancer — all drugs for Head and Neck Cancer →
Head and Neck Lymphedema — all drugs for Head and Neck Lymphedema →

Sponsor

Tactile Medical — full company profile →

Who can join

18 and older, any sex, with Head and Neck Neoplasms or Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fidelity/Adherence Via Subject Diary Primary · From baseline to end of treatment at 8 weeks

Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring fidelity/adherence using a subject diary. Values represent a count of participants who met the prescribed use criteria by week. The prescribed use was defined as two 30 minute sessions in a day.

Week 1

Group	Value	95% CI
Interventional Group	5
Interventional Group	1
Interventional Group	1
Interventional Group	2

Week 2

Group	Value	95% CI
Interventional Group	4
Interventional Group	1
Interventional Group	0
Interventional Group	1

Week 3

Group	Value	95% CI
Interventional Group	4
Interventional Group	0
Interventional Group	1
Interventional Group	2

Week 4

Group	Value	95% CI
Interventional Group	3
Interventional Group	1
Interventional Group	3
Interventional Group	2

Week 5

Group	Value	95% CI
Interventional Group	4
Interventional Group	2
Interventional Group	2
Interventional Group	0

Week 6

Group	Value	95% CI
Interventional Group	2
Interventional Group	2
Interventional Group	0
Interventional Group	2

Week 7

Group	Value	95% CI
Interventional Group	3
Interventional Group	1
Interventional Group	2
Interventional Group	3

Week 8

Group	Value	95% CI
Interventional Group	4
Interventional Group	2
Interventional Group	3
Interventional Group	2

Adverse Events Primary · From baseline to the end of treatment at 8 weeks

Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring adverse events using the CTCAE (v4.0). Values represent the count of events per adverse events category.

Cardiac disorders

Group	Value	95% CI
Wait-list Control Group	3
Interventional Group	0

Ear and labyrinth disorders

Group	Value	95% CI
Wait-list Control Group	1
Interventional Group	1

Endocrine disorders

Group	Value	95% CI
Wait-list Control Group	2
Interventional Group	2

Eye disorders

Group	Value	95% CI
Wait-list Control Group	1
Interventional Group	0

Gastrointestinal disorders

Group	Value	95% CI
Wait-list Control Group	3
Interventional Group	3

General disorders

Group	Value	95% CI
Wait-list Control Group	7
Interventional Group	2

Immune system disorders

Group	Value	95% CI
Wait-list Control Group	1
Interventional Group	0

Infections and infestations

Group	Value	95% CI
Wait-list Control Group	7
Interventional Group	1

Treatment Satisfaction Primary · From baseline to the end of treatment at 8 weeks

Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring treatment satisfaction using a satisfaction survey. A survey assessed participants' perceived ability to control their head and neck lymphedema before (at baseline) and after the usage of the Flexitouch at 8 weeks. Values represent a count of participants who indicated good, very good, or excellent.

Baseline (Good, Very Good, or Excellent)

Group	Value	95% CI
Interventional Group	5

8 Weeks (Good, Very Good, or Excellent)

Group	Value	95% CI
Interventional Group	16

Reduction in Swelling/Inflammation - Endoscopy Secondary · From baseline to the end of treatment at 8 weeks

The change in percent of sites with visible swelling and inflammation as assessed via endoscopy (using Modified Patterson Scale) from baseline to week 8. The range for each anatomical structure includes 1-4: Normal, Mild, Moderate, and Severe. A lower score means a better outcome. A greater negative value indicates a greater reduction in swelling. Total score range: 0-100%.

Group	Value	95% CI
Wait-list Control Group	-2.7778	-16.6667 – 5.5556
Interventional Group	-11.1111	-31.3725 – 8.0882

Reduction in Swelling/Inflammation - Cytokine Levels Secondary · From baseline to the end of treatment at 8 weeks

The presence of swelling and inflammation was assessed in all participants via the change in cytokine levels of Interleukin 6 (IL-6) at baseline to week 8. A lower score means a better outcome. A greater negative value indicates a greater reduction in cytokine levels.

Group	Value	95% CI
Wait-list Control Group	-836.47	-8411.52 – 1142.85
Interventional Group	-275.68	-3772.13 – 4367.30

Reduction in Swelling/Inflammation - Digital Photography Secondary · From baseline to the end of treatment at 8 weeks

The presence of swelling and inflammation was assessed in all participants by digital photography at baseline and 8 weeks. A lower value means a better outcome. A greater negative value indicates a greater reduction in swelling. Three views were scored each with 30 grids. The percentage of views with visible swelling was determined. The score ranged from 0-100%.

Front View Change

Group	Value	95% CI
Wait-list Control Group	4.924	-11.601 – 12.064
Interventional Group	-24.308	-29.167 – -7.143

Right View Change

Group	Value	95% CI
Wait-list Control Group	-7.279	-13.991 – 2.143
Interventional Group	-22.368	-27.273 – -14.286

Left View Change

Group	Value	95% CI
Wait-list Control Group	-4.4466	-17.2348 – 6.8062
Interventional Group	-16.5217	-21.7391 – -2.3810

Reduction in Swelling/Inflammation - Grading of External Lymphedema Secondary · From baseline to the end of treatment at 8 weeks

The presence of swelling and inflammation was assessed in all participants through grading of external lymphedema via the Head and Neck Lymphedema and Fibrosis Assessment criteria (HNLEF) during a physical examination at baseline and 8 weeks. A total of 9 sites were evaluated for the presence of lymphedema and graded from 1 (mild) to 3 (severe) at each site. The number of sites ranged from 0-9 with a total severity score ranging from 0-27. Results are the change in a total score between baseline and 8 weeks. A lower score indicates a better outcome. A greater negative value indicates a greater

Group	Value	95% CI
Wait-list Control Group	-0.5000	-1.0000 – 2.0000
Interventional Group	0.0000	-6.0000 – 2.0000

Function - Jaw Range of Motion Secondary · From baseline to the end of treatment at 8 weeks

The function was assessed in all participants at baseline and week 8 through the jaw range of motion measurements using the Therabite Jaw ROM Scale. The TheraBite Jaw ROM Scale was used to measure in millimeters the jaw opening of the maximum inter-incisal distance (upper right central to lower right central incisor). The values were categorized by grade change. The change of -1 indicates the severity improved by one grade. A value of zero indicates a participant remained stable. A value of 1 indicates a patient worsened by one grade.

Group	Value	95% CI
Wait-list Control Group	4
Interventional Group	1
Wait-list Control Group	18
Interventional Group	17
Wait-list Control Group	2
Interventional Group	1

Function - Neck Disability Index Secondary · From baseline to the end of treatment at 8 weeks

The function was assessed in all participants at baseline and week 8 by the Neck Disability Index (NDI). Values represent a change from baseline. Minimum score: 0 with a minimum disability of 0%. Maximum score: 50 with a maximal disability of 100%. 0 - 20% (minimal) - The patient can cope with most living activities. Usually, no treatment is indicated apart from advice on lifting sitting and exercise. 21 - 40% (moderate) - The patient experiences more pain and difficulty with sitting lifting and standing. Travel and social life are more difficult and they may be disabled from work. The patie

Group	Value	95% CI
Wait-list Control Group	1.00	-4.00 – 9.50
Interventional Group	0.00	-4.00 – 0.00

Function - Voice Handicap Index Secondary · From baseline to the end of treatment at 8 weeks

The function was assessed in all participants at baseline and week 8 by the Voice Handicap Index (VHI). Values represent a change from baseline. Max / Min Total Score: 0-120. A lower score indicates a better outcome.

Group	Value	95% CI
Wait-list Control Group	0.50	-1.94 – 2.75
Interventional Group	0.00	-3.00 – 3.00

Function - Cervical and Shoulder Range of Motion Secondary · From baseline to the end of treatment at 8 weeks

The function was assessed in all participants at baseline and week 8 through the cervical range of motion (CROM) and shoulder range of motion (SROM) measurements. A positive value indicates a better outcome. The greater the value, the greater the change from baseline.

CROM Forward Flexion

Group	Value	95% CI
Wait-list Control Group	-1.00	-8.75 – 8.50
Interventional Group	-2.00	-5.00 – 2.00

CROM Extension

Group	Value	95% CI
Wait-list Control Group	4.00	-5.75 – 12.75
Interventional Group	1.00	-6.00 – 6.00

CROM Left Lateral Rotation

Group	Value	95% CI
Wait-list Control Group	-1.00	-6.50 – 3.00
Interventional Group	-1.00	-6.00 – 6.00

CROM Right Lateral Rotation

Group	Value	95% CI
Wait-list Control Group	-0.50	-7.00 – 3.50
Interventional Group	1.00	-8.00 – 5.00

SROM Forward Flexion (Right Active)

Group	Value	95% CI
Wait-list Control Group	0.00	-3.50 – 6.75
Interventional Group	1.50	-1.00 – 11.00

SROM Forward Flexion (Left Active)

Group	Value	95% CI
Wait-list Control Group	-0.75	-6.37 – 9.13
Interventional Group	7.50	-1.50 – 9.50

SROM Abduction (Right Active)

Group	Value	95% CI
Wait-list Control Group	7.00	-9.00 – 17.00
Interventional Group	3.00	0.00 – 13.00

SROM Abduction (Left Active)

Group	Value	95% CI
Wait-list Control Group	5.50	-13.12 – 12.88
Interventional Group	5.00	-5.50 – 15.00

Symptoms - Vanderbilt Head and Neck Symptom Survey Secondary · From baseline to the end of treatment at 8 weeks

Symptoms were assessed in all participants at baseline and week 8 via the Vanderbilt Head and Neck Symptom Survey plus General Symptom Survey (VHNSS v2.0 plus GSS). Values represent a median score change from baseline. Score range: 0-10. A lower score indicates a better outcome. A more negative value indicates a greater change from baseline. Given this was a self-reported survey, responses were not mandatory and thus missing for some subjects.

Mouth Pain

Group	Value	95% CI
Wait-list Control Group	0.00	-1.29 – 0.50
Interventional Group	0.00	-1.50 – 0.00

General Pain

Group	Value	95% CI
Wait-list Control Group	0.67	-0.25 – 2.08
Interventional Group	0.00	-1.33 – 0.00

Swallowing Solids

Group	Value	95% CI
Wait-list Control Group	-0.06	-1.12 – 0.73
Interventional Group	-0.25	-2.25 – 0.00

Swallowing Liquids

Group	Value	95% CI
Wait-list Control Group	0.00	-1.00 – 1.00
Interventional Group	0.00	-.12 – 0.00

Nutrition

Group	Value	95% CI
Wait-list Control Group	0.00	-0.94 – 1.13
Interventional Group	0.00	-1.00 – 0.25

Mucous

Group	Value	95% CI
Wait-list Control Group	-0.12	-0.75 – 0.69
Interventional Group	-0.50	-1.75 – 0.00

Dry Mouth

Group	Value	95% CI
Wait-list Control Group	0.20	-0.55 – 0.90
Interventional Group	0.00	-0.20 – 0.40

Taste/Smell

Group	Value	95% CI
Wait-list Control Group	-0.25	-1.83 – 0.71
Interventional Group	-0.17	-1.42 – 0.45

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 weeks; and an additional 8 weeks for the Wait-List Control participants who participated in the optional follow-up period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Wait-list Control Group

Serious: 2/24 (8%)

Deaths: 1/24

Interventional Group

Serious: 2/19 (11%)

Deaths: 0/19

Serious adverse events (4 terms)

Reaction	System	Wait-list Control Group	Interventional Group
Cellulitis	Infections and infestations	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—
Stroke	Nervous system disorders	—	—
Sudden death NOS	General disorders	—	—

Other adverse events (42 terms — click to expand)

Reaction	System	Wait-list Control Group	Interventional Group
Pain	General disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Postnasal drip	Respiratory, thoracic and mediastinal disorders	—	—
Surgical and medical procedures - Other, specify	Surgical and medical procedures	—	—
Hypothyroidism	Endocrine disorders	—	—
Upper respiratory infection	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—
Depression	Psychiatric disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Skin infection	Skin and subcutaneous tissue disorders	—	—
Chest Pain - Cardiac	Cardiac disorders	—	—
Hypertension	Cardiac disorders	—	—
Hearing impaired	Ear and labyrinth disorders	—	—
Corneal ulcer	Eye disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Flatulence	Gastrointestinal disorders	—	—
Gastroesophageal reflux disease	Gastrointestinal disorders	—	—
Aphonia	General disorders	—	—
General disorders and administration site conditions - other specify	General disorders	—	—
Neck pain	General disorders	—	—
Oral pain	General disorders	—	—
Allergic reaction	Immune system disorders	—	—
Bladder infection	Infections and infestations	—	—
Eye infection	Infections and infestations	—	—
Middle ear inflammation	Infections and infestations	—	—
Pneumonitis	Infections and infestations	—	—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Dizziness	Nervous system disorders	—	—
Myelitis	Nervous system disorders	—	—
Spasiticity	Nervous system disorders	—	—
Skin and subcutaneous tissue disorders - Other, specify	Skin and subcutaneous tissue disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Hoarseness	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory, thoracic and mediastinal disorders - Other, specify	Respiratory, thoracic and mediastinal disorders	—	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—	—
Hyperthyroidism	Endocrine disorders	—	—
Gastrointestinal fistula	Gastrointestinal disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Presyncope	Nervous system disorders	—	—

Most-reported serious reactions: Cellulitis, Hyponatremia, Stroke, Sudden death NOS.

Data from ClinicalTrials.gov NCT03332160 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial.
Ridner SH, Dietrich MS, Deng J, Ettema SL, et al · · 2021 · cited 23× · PMID 32488435 · DOI 10.1007/s00520-020-05540-8
Implications and Emerging Therapeutic Avenues of Inflammatory Response in HPV+ Head and Neck Squamous Cell Carcinoma.
Castellano LRC, Cruz SBSC, Hier M, Bonan PRF, et al · · 2022 · cited 6× · PMID 36358823 · DOI 10.3390/cancers14215406

Verify or expand the search:

Other recruiting trials for Head and Neck Neoplasms

Currently open trials in the same condition.

NCT07491536 — Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis · NA · recruiting
NCT06912087 — Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC · Phase 1 · recruiting
NCT06998069 — Head and Neck Cancer Study Project in the Geriatric Population · Phase 3 · recruiting
NCT07158164 — DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment · Phase 4 · recruiting
NCT06303180 — NIDCD Otolaryngology Clinical Protocol Biospecimen Bank · recruiting

Other Tactile Medical trials

Trials by the same sponsor.

NCT04797390 — A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema · NA · completed
NCT04335981 — Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression · NA · terminated
NCT04432727 — Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema. · NA · completed
NCT04073823 — A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients · NA · terminated
NCT04116099 — CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03332160 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tactile Medical
Last refreshed: 6 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03332160.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing