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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Shaum S Sridharan, M.D.
- 電話番号：412-647-2130
- メール：sridharans2@upmc.edu
研究連絡先のバックアップ
- 名前：Sridharan
- 電話番号：5126989399
- メール：sridharans2@upmc.edu
研究場所
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- UPMC Presbyterian Hospital and UPMC Shadyside Hospital
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コンタクト：
- Shaum S Sridharan, M.D.
- 電話番号：412-647-2130
- メール：sridharans2@upmc.edu
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Lymphedema Staging
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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internal lymphedema
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Shaum Sridharan, M.D.、Shaum Sridharan, Associate Professor, University of Pittsburgh Medical Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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