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Head and Neck Neoplasms clinical trials

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NCT ID: NCT03700905 Active, not recruiting - Clinical trials for Head and Neck Cancer

Study of Nivolumab Alone or in Combination With Ipilimumab as Immunotherapy vs Standard Follow-up in Surgical Resectable HNSCC After Adjuvant Therapy

IMSTAR-HN
Start date: August 21, 2018
Phase: Phase 3
Study type: Interventional

Multicenter randomized controlled phase III study of nivolumab alone or in combination with ipilimumab as immunotherapy vs standard follow-up in surgical resectable HNSCC after adjuvant therapy

NCT ID: NCT03699969 Active, not recruiting - Clinical trials for Locally Advanced Head and Neck Cancer

A Study Comparing Hypofractionated Dose Escalated VMAT to Conventional CCRT in Locally Advanced Head and Neck Cancer

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

To compare efficacy and toxicity between hypofractionated dose escalated VMAT versus conventional concurrent chemoradiation in locally advanced head and neck cancer

NCT ID: NCT03691714 Active, not recruiting - Clinical trials for Head and Neck Cancer

Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Start date: October 23, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to test the combination of the anti-cancer drugs durvalumab, the study drug, and cetuximab as a treatment for metastatic or recurrent head and neck cancer. Participants will receive both durvalumab and cetuximab.

NCT ID: NCT03688646 Active, not recruiting - Clinical trials for Head and Neck Cancer

Efficacy of ONS Supplementation in HNC Outpatient Under Treatment

Start date: September 2016
Phase: N/A
Study type: Interventional

A RCT study to compare the efficacy of ONS supplementation with standard dietary advice on nutritional outcome inHNC outpatients undergoing treatment in radiotherapy clinic. IThe study population are all adult HNC outpatients receiving radiotherapy with or without chemotherapy treatments at Radiotherapy Clinic,NCI. Selected patient will be randomized into Control Group and Intervention Group until each group have 20 subjects, where the total of sample will be 40 patients (in consideration of 50% dropouts) and data will be collected at baseline (prior to treatment), week 2, 4, and the final data will be at week 6 or final day of cancer treatment. Study objectives are to determine the efficacy of ONS supplementation in outpatient HNC undergoing treatment in Radiotherapy Clinic, NCI, to determine nutritional outcome (weight loss and BMI, body composition, dietary intake, albumin and hemoglobin level), functional outcome (handgrip strength) and side effect outcome (nutrition impact symptoms) in HNC outpatients given intensive nutrition intervention with outpatients given routine care. This study also want to find association of Intensive nutrition intervention versus routine care in nutrition outcome, functional and side effect outcome in both group. Subjects in intervention group will received standardize ONS supplementation every day during treatments once daily with frequent dietary advice accordingly to the patients condition while control group will received standard routine care which includes frequent dietary advice without supplementation of ONS. Study hypothesis is there is no significant difference in nutritional outcome, functional outcome and side effect outcome between HNC outpatients receiving INI when compared to HNC outpatient receiving routine care undergoing radiotherapy treatment. There is also no association between these two groups in nutritional outcome, functional outcome and side effect outcome.

NCT ID: NCT03651570 Active, not recruiting - Clinical trials for Head and Neck Cancer

Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study

Start date: September 25, 2018
Phase: N/A
Study type: Interventional

Informed by a previous trial in general cancer patients, the investigators aim to conduct a multi-centre Phase III explanatory RCT to demonstrate a significant impact of PTSD Coach on levels of anxiety in head and neck cancer (HNC) patients, including saliva and hair cortisol as bio-immunological indicators for stress. However, prior to proposing a larger trial requiring 267 patients, the investigators aim to demonstrate feasibility of recruitment and compliance with protocol procedures in a Phase II Pilot of 60 newly diagnosed HNC patients. The EG will receive PTSD Coach + usual care, compared to two control groups (UC and AC). AC will be comprised of a game app (e.g., Tetris, Candy Crush, or Solitaire) and will be structurally equivalent to the EG to control for distraction (attention on something pleasant or a task) and the human factor involved in usage prompting (i.e., same exposure time + contacts with personnel), since either distraction or the human contact with staff may, alone, lower anxiety. From a resource allocation perspective, it is important to know if the positive effects of PTSD Coach are due to the intervention itself or to the use of an app and its usage prompting. The investigators believe that PTSD Coach will be even more effective at reducing anxiety in HNC patients, as it teaches specific CBT techniques and uses psychoeducation already found to be more effective than distraction alone.

NCT ID: NCT03612531 Active, not recruiting - Dysphagia Clinical Trials

Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors

MANTLE
Start date: August 6, 2018
Phase: N/A
Study type: Interventional

This trial studies how well manual therapy works in treating fibrosis-related late effect dysphagia in head and neck cancer survivors. Manual therapy is the use of massage and stretching exercises to increase blood flow and muscle movement in the neck, throat, jaw, and mouth, which may help to improve swallowing ability and range of motion in participants who have had treatment for head and neck cancer.

NCT ID: NCT03506451 Active, not recruiting - Clinical trials for Head and Neck Cancer

PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study

PaRTNer
Start date: June 19, 2018
Phase: N/A
Study type: Interventional

The purpose of this single institution, pilot study is to explore the out of pocket (OOP)costs and financial toxicity of cancer care for patients during definitive treatment of head and neck cancer with radiation therapy with or without chemotherapy and surgical resection. The study team will assess how the financial burden of cancer care impacts quality of life as well as treatment-related decision-making from a patient perspective.

NCT ID: NCT03494322 Active, not recruiting - Clinical trials for Head and Neck Cancer

EACH: Evaluating Avelumab in Combination With Cetuximab in Head and Neck Cancer

EACH
Start date: July 20, 2018
Phase: Phase 2
Study type: Interventional

Head & neck (H&N) cancer is the eighth most common cancer in the UK. Advanced H&N cancer which has come back after treatment or has spread to other parts of the body is incurable and the average life expectancy of these patients is less than a year. New drugs called immune checkpoint inhibitors work with the patient's own immune system to fight cancer. They are used in the clinic to treat a number of cancers, including H&N cancer. It may be possible to make immune checkpoint inhibitors more effective by combining drugs that work in different ways. In effect, attacking the cancer from different angles. Cetuximab is a well-established drug that works by blocking signals that tell cancer cells to grow and divide into more cells. It also engages with the immune system within the tumour. The trial aims to see if giving cetuximab along with an immune checkpoint inhibitor drug called avelumab is better at treating advanced H&N cancer than giving avelumab on its own. These two drugs have not been given together before, so to start with, the investigator plans to enrol a small number of patients and give the patients avelumab + cetuximab to make sure the combination is safe at the doses chosen. After this, the investigator plans to enrol 114 patients with advanced H&N cancer. Half the patients will be treated with avelumab alone and the other half with avelumab + cetuximab. Both drugs are given intravenously in the hospital once every 2 weeks. Treatment lasts for up to a year and patients will be followed up for up to 2 years from the time they enter the study. Patients will be recruited from around 15 hospitals in the UK. Recruitment would be expected to start in the second quarter of 2018 and it will take about 29 months (Safety run-in: 5 months; Phase II: 24 months) to recruit all the patients.

NCT ID: NCT03491176 Active, not recruiting - Clinical trials for Head and Neck Cancer

Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer

Start date: May 18, 2017
Phase: N/A
Study type: Interventional

The goal of this research study is to find out if using additional MRIs and biomarker testing can help researchers learn to predict how the tumor may change during radiation therapy. Biomarkers are found in the blood/tissue and may be related to participant's reaction to treatment. Biomarker testing in the study may include genetic biomarkers. This is an investigational study. MRIs on this study are performed using FDA-approved and commercially available methods. Having added scans and blood tests is investigational. Up to 100 participants will be enrolled in this study (up to 80 patients and up to 20 healthy volunteers in another part of the study). All will take part at MD Anderson.

NCT ID: NCT03461354 Active, not recruiting - Clinical trials for Head and Neck Cancer

MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

Start date: April 9, 2018
Phase: N/A
Study type: Interventional

This study will examine if the administration of prophylactic MucoLox formulation versus sodium bicarbonate mouthwash in subjects with head/neck cancer receiving radiation ± chemotherapy will result in significantly fewer subjects experiencing severe mucositis.