Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Oral Squamous Cell Carcinoma

Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.

Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a high level.

Resection for primary lesion and cervical lymph node dissection (CLND) are performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.

Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma which tumor budding is a low level.

Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.

Resection for primary lesion and cervical lymph node dissection

Only resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.

Resection for primary lesion only

Jinsong Hou, PhD

Cheng Wang, PhD

The purpose of this study is to determine whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma.

Oral squamous cell carcinoma is the most common malignant tumor of oral and maxillofacial region, and prone to early cervical lymph node metastases. Lymphatic spread is associated with increased risk of loco-regional recurrence, therefore, the identification of lymph node metastases preoperatively is very important for the optimal surgical therapy. Recently, cervical lymph node dissection(CLND) is performed in the presence of oral squamous cell carcinoma. However, whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma is still controversial. CLND will represent over-treatment in some case of early-stage oral squamous cell carcinoma. Therefore, How to accurately predict whether a patient should be performed CLND is important. Our previous study show that tumor budding is closely related to lymphatic spread in the oral squamous cell carcinoma. The purpose of this study is to find that whether the tumor budding guide the individualized surgical planning of early-stage oral squamous cell carcinoma.

A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.

A Randomized，Multicenter，Prospectie，Controlled Clinical Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.

The time from the first operation to death was recorded

The time from the start of surgery to the discovery of the first cervical lymphatic metastases

To investigate the local recurrence rate and the recurrence rate of cervical lymphatic metastasis.

Complete the University of Washington Quality of Life Form (UW-QOL) To understand the quality of life of patients after surgery.

First Affiliated Hospital, Sun Yat-Sen University

Second Affiliated Hospital, Sun Yat-Sen University

Hospital of Stomatology, Sun Yat-Sen University

Jinsong Hou

Vice Director

3 sessions of shoulder rehabilitation per week for 3 months (36 sessions)

sessions of shoulder rehabilitation

A prospective, monocentric, controlled, randomized study of systematic early shoulder rehabilitation following cervical lymph node dissection for the prevention and treatment of shoulder dysfunction.

Pre-inclusion: information, collection of consent, collection of antecedents and biometric data, clinical examination (goniometric measurement and visual analogic scale of pain), collection of DASH, EORTC QLQ-C30 and H\&N35 questionnaires.

Surgical intervention (J0) and randomization into 2 groups:

Group 1 - systematic early rehabilitation Group 2 - without systematic rehabilitation

M3, M6, M12: collection of complications, adjuvant treatments, number of physiotherapy sessions performed, clinical examination (goniometric measurement and visual analogic scale of pain), collection of DASH, EORTC QLQ- C30 and H\&N35 questionnaires.

Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection

The total score is reported. The score is between 0 and 100. The higher the score, the higher the disability.

The reported score is between 0 and 10. The higher the score, the higher the pain.

Goniometric measurement will be performed using a Rippstein's Plurimeter, with standardized position and movement for each measurement:

* Sitting on a chair, the bust is straight, arm hanging down the body.
* The plurimeter is placed on the distal part of the arm.
* The flexion is in the sagittal plane around a transverse axis in the frontal plane.
* The abduction is in the frontal plane around an anteroposterior axis contained in the sagittal plane.

EORTC QLQ-C30 questionnaire has 30 questions and includes the following scale:

- health and overall quality of life, scale have a score between 0 and 100. A high score indicates the preservation of a good quality of life.

EORTC QLQ-C30 questionnaire has 30 questions and includes the following scale:

- operating scale, scale have a score between 0 and 100. A high score for this scale indicates the preservation of a good quality of life.

EORTC QLQ-C30 questionnaire has 30 questions and includes the following scale:

- scale of generic symptoms. scale have a score between 0 and 100. A high score for this scale indicates the presence of symptoms acting as factors of deterioration of certain aspects of the quality of life.

EORTC QLQ-H\&N35 questionnaire evaluates the specific symptoms of patients with head and neck cancers. It consists of 35 items including 7 subscales .

subscale scores are reported, All items and scales give a score between 0 and 100.

For each subscale, a high score indicates the presence of a large number of specific symptoms, acting as factors of deterioration of certain aspects of the quality of life.

(% of rehabilitation sessions performed over 36 sessions)

Nantes University Hospital

Symptoms and General Pathology

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Nervous System Diseases

Pain

Shoulder Pain

Ganglion Cysts

Synovial Cyst

Arthralgia

Joint Diseases

Neurologic Manifestations

A treatment with therapeutic strength exercises, twice a week, for two months, with a total of 10 exercises, with 20 repetitions each, aimed at improving the strength of the trapezius and sternocleidomastoid muscles mainly, as well as improving mobility in flexion, abduction and rotation of the affected upper limb. The protocol will be carried out in approximately 30 minutes.

A treatment with passive kinesitherapy, where the physiotherapist will perform the movements of flexion, abduction and rotation of the shoulder, without the patient's intervention; active kinesitherapy, where the patient will perform specifically prescribed movements, without weight, to improve the articular and muscular balance of the scapulohumeral complex and neurodynamics, where mobilisations of the accessory spinal nerve will be performed through therapeutic exercise and manual neurodynamic therapy. This treatment will be carried out once a week for two months in 30-minute sessions.

A treatment with therapeutic strength exercises, twice a week, for two months, with a total of 10 exercises, with 20 repetitions each, aimed at improving the strength of the trapezius and sternocleidomastoid muscles mainly, as well as improving mobility in flexion, abduction and rotation of the affected upper limb. It will take approximately 30 minutes.

Therapeutic upper limb strength exercise treatment

A treatment with passive kinesitherapy, where the physiotherapist will perform the movements of flexion, abduction and rotation of the shoulder, without the patient's intervention; active kinesitherapy, where the patient will perform specifically prescribed movements, without weight, to improve the articular and muscular balance of the scapulo-humeral complex and neurodynamics, where mobilizations of the accessory spinal nerve will be performed through therapeutic exercise and manual neurodynamic therapy. This treatment will be carried out once a week for two months in 30-minute sessions.

Treatment with passive and active mobilization of the upper limb.

Patricia Martinez-Merinero, PhD

Laura Cabellos

Patricia Martínez-Merinero, PhD

Patricia M Martinez-Merinero, PhD

Objective: To estimate whether oncological physiotherapy treatment with neurodynamic and kinesitherapy (passive and active) in patients with "painful shoulder due to accessory spinal nerve dissection" operated on for head and neck cancer is more effective than standard therapeutic exercise therapy with strength.

Design: Randomized Clinical Trial (intervention study, no drugs). Two branches of rehabilitative treatment applied by oncological physiotherapist.

GROUP I: Treatment of passive and active mobilizations together with neurodynamics techniques.

GROUP II (or control group) Current treatment applied as gold standard, consisting of therapeutic strength exercise, which the patient will carry out under the supervision of the physiotherapist.

The frequency of both will be twice a week for two months.

Study subjects: Participants who underwent cervical ganglion dissection surgery for head and neck cancer, and who have, as a surgical sequela, a painful shoulder due to accessory spinal nerve injury.

Determinations: At baseline (t0), at one month (t1m) and at the end (t6m) will be measured, (1) the degree of pain of the participants through the pain scale (EVA), (2) the functionality of the shoulder, with the DASH scale and goniometry, (3) the quality of life with the QLQ H\&N35 questionnaire, (4) the strength with a hand dynamometer and (5) the degree of neurodynamics of the accessory spinal nerve with the neurodynamic test for this nerve.

Incident cases of painful shoulder due to accessory spinal nerve injury after cervical lymph node dissection in patients with head and neck cancer. Given that clinical data indicate that at least 60% of patients with cervical lymph node dissection have iatrogenic accessory spinal nerve damage, and that the sequelae significantly impair the patient's quality of life, an improvement in quality of life of up to 30% of the QLQ H\&N35 score is considered to be significant.

Participants will be selected through the Spanish Association Against Cancer's needs assessment and first impact service, which receives patients from different hospitals. The investigators will make a first appointment with patients likely to be included in the study to check whether they meet the inclusion/exclusion criteria and collect the necessary data.

The investigators will then proceed to randomization to one of the treatment arms. The planned time for the application of the therapy is 2 months. During the course of the clinical trial the participants will attend treatment twice or once a week with a session duration of approximately 30 minutes.

Participants will be seen three times at the oncological physiotherapy service of the AECC during the course of the study \[t0, t1 and 6tf\]. A first one as mentioned above, an intermediate one after one month and a last one at the end of the clinical trial 2 months after inclusion.

At each of the 3 visits, data on the different variables will be collected: the VAS scale, the QLQ H\&N35 quality of life questionnaire and the DASH questionnaire.

Effectiveness of Oncological Physiotherapy on Painful Shoulder Cervical Ganglion in Head and Neck Cancer

Effectiveness of Oncological Physiotherapy With Neurodynamics and Kinesitherapy (Active+Passive) on Painful Shoulder Cervical Ganglion Post Cervical Evacuation in Head and Neck Cancer Due to Accessory Spinal Nerve of the Accessory Spinal Nerve

The visual analogue scale (VAS) is a 10cm long line where 0 indicates no pain at all and 10 the worst pain imaginable. It is a tool that has shown good reliability values (r = 0.94).

The EORTC Quality of Life questionnaires are developed to assess the quality of life of cancer patients, includes 35 items and scales employ a 4-point response format (''not at all" to ''very much"). A higher score indicates better health

It is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.	NCT02743832	Carcinoma, Squa...	Resection for p... Resection for p...	20 Years - 70 Years	Sun Yat-sen University
Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection	NCT03961802	Rehabilitation	sessions of sho...	18 Years -	Nantes University Hospital
Effectiveness of Oncological Physiotherapy on Painful Shoulder Cervical Ganglion in Head and Neck Cancer	NCT05604235	Cancer Shoulder Pain Rehabilitation	Therapeutic upp... Treatment with ...	18 Years - 80 Years	University of Alcala

Spots Global Cancer Trial Database for cervical lymph node dissection