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Head and Neck Neoplasms clinical trials

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NCT ID: NCT03455608 Active, not recruiting - Dysphagia Clinical Trials

PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer

PRO-ACTIVE
Start date: September 27, 2018
Phase: N/A
Study type: Interventional

Dysphagia (difficulty swallowing) is a common and potentially life-threatening toxicity of radiotherapy (RT) for patients with head and neck cancer (HNC). HNC survivors have a 20-24 percent lifetime risk of pneumonia after RT, which is associated with a 42 percent excess risk of death in survivorship. Moreover, dysphagia predisposes individuals to malnutrition, and at least half of HNC patients require feeding tubes during RT. Patients are commonly referred for swallowing therapy with a speech pathologist. Some patients receive early intervention, before a swallowing problem begins-PRO-ACTIVE therapy. Other patients are monitored and prescribed dysphagia interventions only if and when a swallowing problem occurs-RE-ACTIVE therapy. Thus, REACTIVE therapy aims to reverse an already impaired swallowing ability, whereas PRO-ACTIVE therapy aims to prevent or reduce severity of dysphagia. These two broad categories of therapy represent the most common types of intervention offered to HNC patients across North America. Although there is single-institution evidence to support each practice, it is yet unknown which is most effective. To address this gap, the primary aim of this international, multi-site 3-arm pragmatic randomized clinical trial is to compare the effectiveness of PRO-ACTIVE (high and low intensity) versus RE-ACTIVE swallowing therapy among 952 patients with HNC planning to undergo RT, using duration of feeding tube dependence after RT as the primary outcome. Our secondary aim proposes to compare the relative benefit or harm of these swallowing interventions on secondary outcomes considered relevant to our stakeholder partners.

NCT ID: NCT03401840 Active, not recruiting - Clinical trials for Head and Neck Neoplasms

STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03

STEREOPOSTOP
Start date: January 23, 2018
Phase: N/A
Study type: Interventional

The main objective of this national, open-label, non-randomized phase II trial is to evaluate severe late toxicity of postoperative hypofractionated stereotactic radiotherapy (SBRT) in the treatment of early stage oropharyngeal and oral cavity cancer with high risk margins.

NCT ID: NCT03355560 Active, not recruiting - Clinical trials for Head and Neck Cancer

Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy

Start date: December 6, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to test the safety and efficacy of nivolumab after salvage resection in head and neck cancer in patients that have previously received definitive radiation with or without chemotherapy.

NCT ID: NCT03258554 Active, not recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin

Start date: April 3, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This phase II/III trial studies how well radiation therapy works with durvalumab or cetuximab in treating patients with head and neck cancer that has spread to a local and/or regional area of the body who cannot take cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. It is not known if radiation therapy with durvalumab will work better than the usual therapy of radiation therapy with cetuximab in treating patients with head and neck cancer.

NCT ID: NCT03247712 Active, not recruiting - Clinical trials for Head and Neck Cancer

Neoadjuvant Immunoradiotherapy in Head & Neck Cancer

Start date: January 15, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the safety of neoadjuvant immunoradiotherapy as a safe means of down-staging Head and Neck Squamous Cell Carcinoma (HNSCC) prior to surgical resection.

NCT ID: NCT03217188 Active, not recruiting - Clinical trials for Head and Neck Cancer

Proton Re-Irradiation for Recurrent Head and Neck Cancer

Start date: July 10, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the tumor control and the side effects of using proton therapy for head and neck cancer that has come back.

NCT ID: NCT03194061 Active, not recruiting - Clinical trials for Radiotherapy; Complications

Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer

HIPOCP
Start date: January 1, 2015
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the feasibility of hypofractionated radiation therapy and concomitant chemotherapy with cisplatin for locally advanced head and neck cancer in a high volume brazilian center.

NCT ID: NCT03146338 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

Prophylaxis of Magnesium-rich Mineral Water to Prevent Hypomagnesemia Induced by an Anti-EGFR (OPTIMAG)

OPTIMAG
Start date: July 4, 2017
Phase: N/A
Study type: Interventional

Anti-EGFR (Epidermal Growth Factor Receptor) therapies, namely cetuximab and panitumumab, have become standards in the management of metastatic colorectal and head and neck cancers. These therapies are used in daily practice, that requiring to manage their skin and digestive toxicities. However, anti-EGFR are also frequently responsible for hypomagnesemia often neglected and under-treated. Hypomagnesemia may manifest as asthenia, cramps, muscle weakness, mood disorders. She is often underestimated because they are difficult to identify and accountable by clinicians in the context of cancer under chemotherapy. There is currently no national or international recommendation on the management of hypomagnesaemia in oncology and medicine in general. There are, however, on the market many nutritional supplements rich in magnesium in the form of tablets or oral solution, in multiple dosages. These food supplements rich in magnesium are sold without proof of effectiveness. Moreover, the prescription of oral magnesium supplementation adds to the oncology patient an over-medicalization, which can be poorly tolerated at the digestive level, and responsible for diarrhea and a lack of compliance. The European Food Safety Authority (EFSA) recommends in its opinion on "Dietary reference values for water" to consume 2 liters for women and 2.5 liters for men every day, all sources combined (food and beverages). The drink represent 80% of the water intake, that is about 1.5 Liter per day excluding food. However, there are multiple water marketed or distributed freely, with different compositions. Thus the quantity and quality of the mineral water consumed can influence the metabolism. Rozana® mineral water, has the double advantage of being the French water the most concentrated in magnesium (160 mg / L) and of being lowly concentrated in sulphate, responsible of the laxative power of certain waters. Instead of adding magnesium supplements with a poor digestive tolerance, to patients with metastatic cancer and often with a heavy treatment , the aim of this study is to evaluate whether a change in oral hydration in quantitative and qualitative terms can decrease the rate of hypomagnesemia in patients treated with anti-EGFR.

NCT ID: NCT03114501 Active, not recruiting - Clinical trials for Head and Neck Cancer

Dyadic Yoga Intervention for Patient With Head and Neck Cancer Undergoing Radiotherapy and Their Family Caregivers

Start date: April 11, 2017
Phase: N/A
Study type: Interventional

Objectives: Primary Aim: Examine the feasibility of a dyadic yoga program in 40 Head and Neck Cancer (HNC) patients undergoing radiotherapy (RT) and their family caregivers. Secondary Aims: 1. Establish the initial efficacy of the yoga program in patients and their caregivers regarding quality of life (QOL) outcomes (i.e., fatigue, sleep disturbance, depressive symptoms, and overall QOL) and objective performance outcomes (i.e, sit to stand test and grip strength).

NCT ID: NCT03096184 Active, not recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

A Study of Apatinib Plus Tegafur Gimeracil Oteracil in Recurrent/Metastatic Head and Neck Cancers

Start date: December 23, 2016
Phase: Phase 2
Study type: Interventional

This is a non-randomized, phase II, open label study of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules in recurrent/metastatic squamous cell carcinoma of head and neck. The primary purpose of this study is to evaluate the efficacy of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules in recurrent/metastatic squamous cell carcinoma of head and neck