Behaviors and Mental Disorders

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Anxiety Disorders

Breast Neoplasms

Head and Neck Neoplasms

Mental Disorders

Psychotic Disorders

Virtual reality exposure just before an oncological procedure (invasive act or a chemotherapy)

Patients will be exposed to a 10-20 min virtual reality session just before an oncological procedure (invasive act or chemotherapy).

Patients will be able to choose between 4 virtual universes (beach, underwater, forest, space) and seven musical content.

Virtual reality exposure

The aim of the REV clinical trial is to evaluate the impact of a virtual reality exposure to decrease patient anxiety before chemotherapy or an invasive act. If positive, the access to virtual reality exposure is aimed to be used as standard of care at Lyon's hospital to improve cancer patient well-being in a drug-free manner.

The majority of cancer patients lives with high level of anxiety as soon as diagnosed. This level anxiety is particularly high before invasive acts but also before chemotherapy by side effects anticipation.

Hypnosis is a highly interesting drug-free approach to decrease patient's anxiety. It however requires on site specialists to be available whenever needed.

Virtual reality provides a distractive environment enabled to shift patient focus. It can support a switch of patient mindset by providing positive emotions.

Since 5 years, this disruptive technology is being more and more used as medical support thanks to a new generation of headsets enabling improved performance at cheaper prices.

Many publications have now demonstrated the positive impact of virtual reality to take in charge patients' pain or pre-operational anxiety.

The primary objective of the REV study is to demonstrate the difference of anxiety before and after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y) before patients undergo an oncological procedure (invasive act or chemotherapy (C1D1).

The investigator's REV study aims to recruit 66 patients among three cohorts (22 patients per cohort) in 12 months.

* Breast cancer cohort (patient receiving an adjuvant or neoadjuvant chemotherapy with doxorubicin and cyclophosphamide)
* Head or neck cancer cohort (patient treated by concomitant radiochemotherapy)
* Cancer patient for which an invasive act inducing anxiety is planned (lumbar puncture, ascites puncture, thoracocentesis, myelogram, bone marrow biopsy, urinary catheterization, ..)

The REV study aims to impact Lyon's hospital patients' quality of life and well-being by decreasing their anxiety level during oncological treatments thanks to innovative supportive cares.

44 patients for the cohort " chemotherapy " and 22 patients for the cohort " invasive act ".

Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act

Difference of anxiety before and after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y; A-State Scale) before patients undergo an oncologic procedure (invasive act or chemotherapy (C1D1).

Difference of anxiety before and after a virtual reality exposure using a self-evaluation anxiety inventory before patients undergo an oncologic procedure (invasive act or chemotherapy (C1D1).

Comparison of responses between self-evaluation anxiety inventory before and after virtual reality exposure just before an oncologic procedure (invasive act or a chemotherapy)

Difference of anxiety before and after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y; A-State Scale) or the Self-evaluation anxiety inventory before patients undergo chemotherapy (C1D1, C2D1, C3D1).

Comparison of responses between the STAI-Y; A-State Scale or the Self-evaluation anxiety inventory before and after virtual reality exposure just before chemotherapy

Difference of anxiety before and after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y; A-State Scale) or the Self-evaluation anxiety inventory before patients undergo an invasive act.

Comparison of responses between the STAI-Y; A-State Scale or the Self-evaluation anxiety inventory before and after virtual reality exposure just before an invasive act

Patient basal anxiety level using STAI-Y; A-State Scale, STAI-Y; Trait-State Scale or the Self-evaluation anxiety inventory just before an oncologic procedure (invasive act or a chemotherapy).

Quotation of patient basal anxiety level using STAI-Y; A-State Scale, STAI-Y; Trait-State Scale or the Self-evaluation anxiety inventory just before an oncological procedure (invasive act or a chemotherapy)

Determination of patient anxiety level evolution through 3 cycles of chemotherapy using the STAI-Y; A-State Scale and the Self-evaluation anxiety inventory (just before virtual reality exposure, after virtual reality exposure, after 1 hour of chemotherapy).

Comparison of responses between the STAI-Y; A-State Scale and the Self-evaluation anxiety inventory before virtual reality exposure, after virtual reality exposure and after 1 hour of chemotherapy

Hospices Civils de Lyon

Symptoms and General Pathology

Recurrence

Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data only

Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional biobank sampling

Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional quality of life data

Patients undergoing treatment for histologically proven or suspected recurrent cancer of the head and neck - clinical data and optional quality of life data and optional biobank sampling

IReC is the world's first centre for recurrent head and neck cancers. We have the ambitious aim to create a centre of international excellence and set international standards in the curative treatment of recurrent head and neck cancers.

One of IReC's key objectives is to develop a national research tissue bank to support laboratory and translational research. The cornerstone of translational research is a well-annotated biobank of cancer samples to explore and validate key research findings.

The purpose of IReC-Bio is to support research into recurrent head and neck cancers. A central repository for the rarer recurrent cancers will allow the concentration of cases required in order to support translational research programmes. The overall aim is to facilitate research into understanding disease biology, identifying potentially curative treatments, and allow detailed investigations into the relationships between clinical, pathological and molecular characteristics and clinical outcomes.

Combining the IReC Registry and Biobank gives us a comprehensive data and sample set which has never been created before for recurrent head and neck cancer. The aim is to have a national, and in the future international, resource of the study of recurrent head and neck cancer on a molecular and clinical level to support novel ways of treating rHNC.

There are currently only a limited number of proven treatments for use in cancers of the head and neck, and a better understanding of the biology of different HNCs could lead to improved therapies. Although many patients with head and neck cancer can be offered potentially curative treatment, we do not understand why some people are cured and others are not. There has been an explosion in molecular research in many cancers, but this remains an understudied area in head and neck cancer. There are currently no treatments available to patients with head and neck cancer based on molecular characteristics.

The purpose of IReC-BIO is to support research into rHNCs. A central repository for the rarer recurrent cancers will allow the concentration of cases required in order to support translational research programmes. The overall aim is to facilitate research into understanding disease biology, identifying potentially curative treatments, and allow detailed investigations into the relationships between clinical, pathological and molecular characteristics and clinical outcomes.

Cancer registries store large quantities of data from defined cancer populations. Registry aims vary, but include analysing cancer trends over time and supplying data for research studies5-7. The NCDB and SEER are extensively studied registries, producing \>200 publications per year6. Both provide a broad overview of all major cancers; however, they have notable datapoint gaps, in particular, recurrence and patient reported outcome measures (PROMs).

Establishing a cancer registry necessitates a balance of clinical, informatic, and financial influences. Cancer registry development is subject to numerous pitfalls, ranging from excessive datapoints to inadequate quality assurance7. These can be mitigated through adherence to best practice recommendations, for example the NAACCR and ENCR, which provide guidelines that standardise registry datasets8,9. However, not all recommendations are practical across all cancer diagnoses. In particular, rHNC requires a tailored approach to document the treatment and functional implications unique to this cohort, necessitating development of a registry specific to this disease.

Surplus tumour tissue and an optional EDTA blood sample will be collected

IReC-Bio and IReC Registry

Protocol for The International Centre for Recurrent Head and Neck Cancer (IReC) Tissue Biobank and Data Registry

2-year overall survival from date of diagnosis

2 year disease free survival, disease specific and local recurrence free survival rates in all patients with rHNC

1 and 2-year gastrostomy and tracheostomy status from date of diagnosis

Entry, 6, 12 and 24-month PSS-HN NOD scores

Royal Marsden NHS Foundation Trust

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Endometrial Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Allergic Agents

Antiemetics

Central Nervous System Depressants

Gastrointestinal Agents

Dermatologic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Diphenhydramine

Promethazine

Famotidine

Cetirizine

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Histamine H1 Antagonists, Non-Sedating

Diphenhydramine 50 mg intravenous given in a 50 milliliters bag of sodium chloride 0.9 percent, with famotidine, 30 minutes before the paclitaxel infusion. 15 minutes infusion.

Lactose tablet 100 mg per os given 30 minutes before the paclitaxel infusion.with a 180 milliliters glass of water.

Cetirizine tablet 10 mg per os given 30 minutes before the paclitaxel infusion.with a 180 milliliters glass of water.

1 milliliter of sodium chloride 0,9 percent intravenous given in a 50 milliliters bag of sodium chloride 0.9 percent, with famotidine, 30 minutes before the paclitaxel infusion. 15 minutes infusion.

Lactose pill

Sodium chloride 0.9%

Matthieu Picard, M.D.

Explore the randomized, controlled, double-blind design targeted for the final clinical trial to assess the acceptability of interventions and clinical outcome measures and to provide data making it possible to estimate the parameters necessary for the preparation, modification or even abandonment of the final study.

Paclitaxel is known to cause 30 to 40% of infusion-related reactions when no premedication is administered. It is agreed that all patients should receive premedication with dexamethasone, an H1 antagonist, such as diphenhydramine, and an H2 antagonist before the administration of paclitaxel. There are several cases where undesirable effects (eg. drowsiness, dry mouth, motor impatience) have been reported following the administration of this conventional premedication. Diphenhydramine is often accused because of its pharmacological properties.

A definitive, randomized, double-blind, non-inferiority study can assess whether cetirizine, a non-sedating H1 antagonist, can be used as an effective and safe alternative to diphenhydramine in the prevention of paclitaxel infusion-related reactions.

In the current proposed feasibility study, patients will be followed for the first two doses of paclitaxel. The goal is to explore the randomized, controlled, double-blind design targeted for the final clinical trial to assess the acceptability of interventions and clinical outcome measures and to provide data making it possible to estimate the parameters necessary for the preparation, modification or even abandonment of the final study.

Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel

Feasibility of a Randomized Controlled Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel

Number of participants who will have completed the study in each group divided by the number of participants recruited in each group

At the end of paclitaxel infusion of treatment 2

At the end of paclitaxel infusion of treatment 1 and 2

Focus on drowsiness, dry mouth, eyes or nose, dizziness and restlessness/excitement. For treatment 1 and treatment 2.

Number of participants per month recruited for which a first dose of paclitaxel was administered

Number of participants recruited, randomized and having received the first treatment of paclitaxel planned in the study divided by the number of participants eligible to participate in the study

Stopping the infusion and using rescue medication defined by the medical choice of the attending physician. For treatment 1 and treatment 2.

Grades will be determined using nurses notes. For treatment 1 and treatment 2

Ciusss de L'Est de l'Île de Montréal

Assitant clinical professor

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

IK-175 + nivolumab

Katherine Kim, MD

Karim Malek, MD

This is a phase 1b study in adult patients diagnosed with resistant or recurrent head and neck squamous cell carcinoma (HNSCC) designed to assess the safety and tolerability of IK-175 in combination with nivolumab. Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed.

This is an open-label, multicenter, phase 1b dose-expansion study to evaluate the safety, tolerability, preliminary antitumor activity, PK, and pharmacodynamics of 2 dose levels of IK-175, administered PO in combination with nivolumab, in patients with primary PD-1-resistant metastatic or locally incurable, recurrent HNSCC for which standard therapy is no longer effective or is intolerable.

Oral AHR Antagonist in Combination With Nivolumab in Patients With PD-1 Resistant Metastatic or Recurrent Head and Neck Cancer

A Phase 1b, Open-Label, Single-Arm Dose-Expansion Study of IK-175, an Oral Aryl Hydrocarbon Receptor Inhibitor, in Combination With Nivolumab in Patients With Primary PD-1 Inhibitor Resistant Metastatic or Locally Incurable, Recurrent HNSCC

Number and severity of TEAEs as assessed by CTCAE 5.0

Number and severity of TRAEs as assessed by CTCAE 5.0

Number and severity of SAEs as assessed by CTCAE 5.0

Number and severity of adverse events leading to dose modifications and/or treatment discontinuation as assessed by CTCAE 5.0

ORR is defined as the percentage of participants with confirmed complete response (cCR) or confirmed partial response (cPR) per RECIST 1.1

DCR is defined as the percentage of participants with no occurrence of progressive disease with either cCR, cPR, or stable disease \[SD\] ≥ 16 weeks per RECIST 1.1 from the beginning of study therapy

DOR is defined as the time from the first documented CR or PR per RECIST 1.1 until disease progression or death from any cause

PFS is defined as the length of time from the beginning of study treatment to the first observed disease progression or death due to any cause

OS is defined as the length of time from the beginning of study treatment to the date of death due to any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act	NCT04419077	Anxiety Chemotherapy Ef... Breast Cancer Head Cancer Nec...	Virtual reality...	18 Years -	Hospices Civils de Lyon
IReC-Bio and IReC Registry	NCT05885490	Head Cancer Nec...		-	Royal Marsden NHS Foundation Trust
Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel	NCT04237090	Breast Cancer Lung Cancer Ovarian Cancer Oesophageal Can... Head Cancer Nec... Cervical Cancer Endometrial Can...	Diphenhydramine Cetirizine Lactose pill Sodium chloride...	18 Years -	Ciusss de L'Est de l'Île de Montréal
Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel	NCT04237090	Breast Cancer Lung Cancer Ovarian Cancer Oesophageal Can... Head Cancer Nec... Cervical Cancer Endometrial Can...	Diphenhydramine Cetirizine Lactose pill Sodium chloride...	18 Years -	Ciusss de L'Est de l'Île de Montréal
IReC-Bio and IReC Registry	NCT05885490	Head Cancer Nec...		-	Royal Marsden NHS Foundation Trust
Oral AHR Antagonist in Combination With Nivolumab in Patients With PD-1 Resistant Metastatic or Recurrent Head and Neck Cancer	NCT05472506	Head and Neck S... Head and Neck C... Head Cancer Neck Cancer Head Cancer Nec... Neck Carcinoma	IK-175 + nivolu...	18 Years -	Ikena Oncology

Spots Global Cancer Trial Database for head cancer neck