Preventing Lymphedema in Patients Undergoing Surgical Treatment for Head and Neck Cancer Through Vein Reconstruction
Lymphedema Prevention With Facial Vein Preservation or Reconstruction During Neck Dissection for Operable Head & Neck Cancer
* The goal of this clinical trial is to learn if facial vein reconstruction after neck dissection works to reduce rates of lymphedema in adults getting surgical treatment for head and neck cancer.
This is a trial which aims to improve the rate of lymphedema for patients undergoing treatment for head and neck cancer. Our aim is to re-establish venous flow across the facial vein to improve lymphatic drainage after neck dissection.
- The investigators will also evaluate lymphatic flow before and after facial vein reconstruction to determine if there is evidence of lymphedema.
The main questions this study aims to answer are:
- Does facial vein reconstruction after neck dissection improved lymphatic flow in head and neck cancer patients?
- Determine if there are changes in lymphatic flow before and after facial vein reconstruction?
After the study is completed, the investigators will compare rates of lymphedema and quality of life in patients with facial vein preservation/reconstruction as compared to previous patients treated for head and neck cancer without facial vein reconstruction.
Participants will undergo the following:
- Oncologic and reconstructive surgery as normal. No changes in cancer treatment will occur due to the study.
- When necessary, participants will undergo facial vein reconstruction immediately after neck dissection
- Visit the clinic once every 3 months for routine checkups and tests. This is typical for most patients treated for head and neck cancer including those not enrolled in the trial.
- Fill out short questionnaires to help understand quality of life after head and neck cancer treatment
- Undergo lymphography in the OR and at the 1-year mark in the office. This is a simple test performed without radiation exposure. It requires 3 very small skin injections to perform the test.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Shaum S Sridharan, M.D.
- Telefonnummer: 412-647-2130
- E-post: sridharans2@upmc.edu
Studer Kontakt Backup
- Navn: Sridharan
- Telefonnummer: 5126989399
- E-post: sridharans2@upmc.edu
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15213
- UPMC Presbyterian Hospital and UPMC Shadyside Hospital
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Ta kontakt med:
- Shaum S Sridharan, M.D.
- Telefonnummer: 412-647-2130
- E-post: sridharans2@upmc.edu
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Ability to comply with the study protocol, including follow up visits and additional requirements for data collection
- Ability to provide informed consent
- Patients requiring unilateral or bilateral neck dissection. Patients must undergo at least three level neck dissection which must include level 1B
- Patients will undergo radiotherapy +/-chemotherapy after surgery for HNC. Patients will be required to have adjuvant therapy after surgery to have similar risk of development of lymphedema.
- No history of allergy to indocyanine green.
Exclusion Criteria:
- Shellfish Allergy
- Contraindication to surgery under general anesthesia
- Prior head and neck surgery, radiation, or chemotherapy for HNC
- Patients requiring sacrifice of the internal jugular vein or resection of neck skin for oncologic care
- Anticipated partial or total laryngectomy
- Pregnancy or lactation
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Facial Vein Reconstruction Group
When necessary, participants will get facial vein reconstruction immediately after neck dissection.
Participants will also undergo lymphography before and after vein reconstruction.
If the facial vein is intact, no intervention is needed, but the patient may still participate in the study.
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Immediately after neck dissection, the facial vein will be assessed.
If the vein has been ligated for the neck dissection, then the vein will be repaired.
This may require vein graft and the use of a venous coupler.
If the vein is intact after neck dissection, we can proceed without surgical intervention.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Lymphedema Staging
Tidsramme: before surgery and every three months after surgery up to 1 year
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The primary endpoint is the presence or absence of head and neck lymphedema (HNL) at follow-up, assessed using the MD Anderson Cancer Center Head and Neck Lymphedema (MDACC HNL) Scale. This scale is measured from 0 to 2. As the numbers increase, the severity of lymphedema increases. A score of 0 means there was no lymphedema present |
before surgery and every three months after surgery up to 1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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internal lymphedema
Tidsramme: before surgery and every 3 months after surgery up to 1 year
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We will utilize the Patterson Internal lymphedema scale to assess lymphedema during routine flexible laryngoscopy in the clinic. Patient will be undergoing flexible laryngoscopy as part of routine surveillance. Several sites within the larynx and hypopharynx are graded as to the severity of edema(swelling). Each site is rated as none, mild, moderate, or severe edema. |
before surgery and every 3 months after surgery up to 1 year
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Head and Neck Lymphedema and Fibrosis Symptom Inventory
Tidsramme: These will be performed before surgery and every 3 months after surgery up to 1 year
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The Head and Neck Lymphedema and Fibrosis Symptom Inventory (HNLEF) is the only validated symptom scale specific for HNL. HNLEF represents a 33 item survey around 7 domains of survivorship including soft tissue and neurologic toxicity, social functioning, oral dysfunction, body image, taste and swallowing, mucosal irritation, and communication. HNLEF has been shown to capture HNL-related symptom burden and functional impairments. Quality of life in regards to head and neck lymphedema are deemed worse with higher scores. This tool contains 33 items (symptoms), which are answered in a "yes" or "no" format. If patients answer "yes" to any given item, they are then asked to rate the intensity of the respective symptom on a five-point scales. Each item then receives a score ranging from "0" (Does not experience the symptom) to "5" (Experiences the symptom with severe intensity). Scores can be examined with individual symptoms or based on average score for each subscale. |
These will be performed before surgery and every 3 months after surgery up to 1 year
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Indocyanine Green Near-infrared imaging
Tidsramme: intraoperatively and at 1 year following surgery
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We will identify quality of head and neck lymphatic flow including disruption of lymphatic pathways and areas of pooling of indocyanine green. Several observations will be recorded based on imaging. These will be deemed as present or absent without scale.
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intraoperatively and at 1 year following surgery
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The University of Washington Quality of Life
Tidsramme: Before surgery and every 3 months up to 1 year after treatment.
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The University of Washington Quality of Life (UW-QOL Version 4) is a validated and reliable measure of physical and social-emotional QOL widely used in head and neck cancer.
Twelve items assessing appearance, swallowing, chewing, speech, taste, saliva, pain, activity, recreation, shoulder function, mood, and anxiety are scored on a scale from 0 (worst possible response) to 100 (best possible response).
Physical and social-emotional subscale scores range from 0 to 100, with higher scores indicating better QOL.
A minimal clinically important difference (MCID) on the UW-QOL v4 subscales is generally considered to be approximately 5 points, representing a change that patients are likely to perceive as meaningful.
A moderate clinically important change has been estimated at approximately 10 points, reflecting a more substantial improvement in patient-reported outcomes.
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Before surgery and every 3 months up to 1 year after treatment.
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The Functional Oral Intake Scale
Tidsramme: Before surgery and every 3 months up to 1 year after treatment
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The Functional Oral Intake Scale (FOIS) can be utilized to measure oral intake ability before and after treatment.
FOIS has been used across specialties and utilized a grading symptoms from 1-5.
Level 1 indicates nothing taken orally; Level 2 indicates tube reliance with few attempts to take food or drinks orally; Level 3 indicates tube dependence with regular oral intake of food or liquids; Level 4 indicates a total oral diet but requires special preparations, compensations, or not expanded from whole-bottle feeding; and Level 5 indicates a total oral diet without special preparation.
A higher score represents more swallowing disability
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Before surgery and every 3 months up to 1 year after treatment
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Shaum Sridharan, M.D., Shaum Sridharan, Associate Professor, University of Pittsburgh Medical Center
Publikasjoner og nyttige lenker
Studierekorddatoer
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Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
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Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY26010093
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