Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Dyspnea

Respiratory Aspiration

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.

Deliver air in and out of the lungs, warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils.

Vapotherm

Air given through a mask, and amount can be set to different levels allowing more air in and out of lungs without using as much effort as regular breathing.

BIPAP

David Hui, MD

The goal of this clinical research study is to learn if specialized breathing devices reduce the sensation of shortness of breath in patients with advanced cancer who are experiencing shortness of breath. Researchers want to learn if these devices can help to control shortness of breath.

The 2 devices being tested and compared are called BiPAP (bilevel positive airway pressure) and Vapotherm.

Study Devices:

The BiPAP device is designed to help people get more air in and out of their lungs without using as much effort as regular breathing. The air is given through a mask, and the amount of air can be set to different levels.

The Vapotherm device is also designed to deliver air in and out of the lungs. The air is warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.

* Group 1 will receive air through BiPAP for up to 2 hours and then air through Vapotherm for up to 2 hours.
* Group 2 will receive air through Vapotherm for up to 2 hours and then air through BiPAP for up to 2 hours.

The study staff will help you use the devices.

If you have trouble with one of the devices, you can be switched to the other device before the 2-hour period is over.

After using the first device, you will wait for up to 60 minutes before switching over to the other device. This waiting period will occur no matter if you used the first device for the full 2 hours or not.

During the waiting period, you will return to the same air delivery device and oxygen level that you were using just before you started the study. The study staff will also be checking to see if you are still eligible to use the second device.

Study Tests:

During the study period, your vital signs and level of air breathed out will be recorded using a measuring device on your chest.

Before and after using the devices, you will rate how hard it is to catch your breath.

After using the second device, you will fill out a questionnaire that has questions about which device you prefer. This should take less than 5 minutes.

Length of Study:

You will be on this study for up to 5 hours. You will be taken off study and the device will be stopped if intolerable side effects occur while using a study device.

Use of Other Drugs:

During the 4-5 hour study period, you will not be allowed to take certain drugs for standard care that may affect the study tests. These drugs include certain pain-killer drugs (such as morphine and hydromorphone), steroids (such as prednisone and dexamethasone), and inhaled drugs (such as ipratropium and salbutamol).

Any doses of inhaled drugs (regularly scheduled doses and "as needed" doses) and any "as needed" doses of pain-killer drugs and steroids that fall within the 4-5 hour study period will be put on hold and will be given to you right after the study is complete.

You may, however, choose to take these drugs, either because your shortness of breath is not controlled, or because these drugs are needed to treat other problems (such as pain). If you and your doctor decide that you should take these drugs during the study period, you will be taken off study so you can receive these drugs. The reason for stopping your study participation is that these drugs may affect how you rate your shortness of breath.

This is an investigational study. The BIPAP and Vapotherm devices are commercially available and FDA approved for delivering oxygen when medically needed, including in patients with advanced cancer. The investigational part of this study is to collect information from asking patients to rate how well the study devices may affect shortness of breath.

Up to 50 patients will be enrolled in this study. All will be enrolled at MD Anderson.

High Flow Oxygen and Bilevel Airway Pressure for Persistent Dyspnea in Patients With Advanced Cancer

An Exploratory Trial of Bilevel Positive Airway Pressure Device and High Flow Oxygen for Persistent Dyspnea in Advanced Cancer Patients

Retention rate defined as the percentage of subjects able to complete the first phase (washout) of study.

A variable washout/follow-up period after the first intervention was used to determine the optimal duration required for participants to return to baseline dyspnea level. After participants completed the first intervention by one hour, they were able to proceed to the second intervention if (1) their dyspnea level was \>/= baseline dyspnea level-1, or (2) their dyspnea level was \>/= 3/10 after one hour.

Dyspnea, a subjective sensation experienced by participants, was assessed with the numeric rating scale (NRS) before and after each 2 hour intervention. The NRS is a validated 11-point scale ranging from 0 (no dyspnea) to 10 (worst dyspnea). Participants received either (1) 2 hours of HFO followed by a variable washout period and then 2 hours of BiPAP or (2) 2 hours of BiPAP followed by a variable wash-out period and then 2 hours of HFO.

M.D. Anderson Cancer Center

Adverse events were recorded at enrollment before measurements/interventions were completed while participants were on baseline oxygen. No adverse events were reported/associated with device use during treatment periods therefore reporting was provided by group assignment rather than treatment received.

Bilevel positive airway pressure device (BiPAP) air delivery then Vapotherm device air delivery.

Group1: BiPAP Then Vapotherm

Vapotherm device air delivery then Bilevel positive airway pressure device (BiPAP) air delivery.

Group 2: Vapotherm Then BiPAP

Group 1: BiPAP Then Vapotherm

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

David Hui, MD, MSc, FRCPC

Completed washout period

Completed second intervention

Number of Participants Completing Study Intervention

Dyspnea NRS at the time of enrollment

Dyspnea NRS after intervention

One participant assigned to receive BiPAP was mistakenly started on Vapotherm (High Flow Oxygen = HFO), and was reported here in the HFO group.

Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale

Bilevel positive airway pressure device (BiPAP) then high flow oxygen (HFO) delivery using Vapotherm device.

First Intervention (2 Hours)

Washout Period (1 Hour)

Second Intervention (2 Hours)

Cancer Pain

Pain

Breakthrough Pain

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Fentanyl

Morphine

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

* Baseline period: 7-15 episodes of breakthrough cancer pain treated with prior IR opioid medication
* Treatment period: Conversion to SL Fentanyl at a Fentanyl:Prior opioid conversion factor of 1:50 (using the estimated Morphine Sulphate Equivalent dose for the prior opioid). SL Fentanyl use was followed for 8-15 episodes of breakthrough cancer pain. SL Fentanyl dose could be titrated between episodes.

SL fentanyl will be administered during 7- 15 BTcP episodes during a maximum period of 21 days, following a baseline period with standard BTcP treatment. The start dose of SL fentanyl is selected individually according to a standardized conversion ratio. The maximum start dose is limited to 400 μg. For a single BTcP episode no more than two (2) tablets or a maximum dose of 800 μg should be given.

SL fentanyl

Anders Pettersson, MD, PhD

The purpose of this study is to evaluate safety and efficacy when using a novel dose conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).

The study aims to show that in the advanced stage of cancer the individual patient already on high doses of BTcP medication will benefit from starting treatment on a higher first dose of SL fentanyl thus reducing the number of dosing steps with insufficient pain relief.

Conversion From Fast Acting Oral Opioids to Abstral®

Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain

A subject is defined as responder if the change of Pain Intensity (PI) on the Numerical Rating Scale (NRS) rated from 0 to 10, at 30 minutes (PID30) is similar or higher after the conversion to SL fentanyl compared to baseline PID30 as assessed by standard care rescue treatment of BTcP episodes.

Orexo AB

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Anemia

Hematologic Neoplasms

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Hematinics

Epoetin Alfa

Patient with AML de novo or secondary myelodysplasia, in Complete Remission (CR) after induction and / or salvage therapy and candidate to receive a consolidation therapy

Patient with hematologic malignancies (ALL, AML, chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma, myeloma, myeloproliferative syndrome (MDS)) and candidate for blood marrow or stem cell or placental blood transplantation.

Jeremy MONFRAY, MD-PHD

Mauricette Michallet, Prof.

Anemia concerns a lot of patients with cancer and affects their quality of life (QOL). Numerous studies in oncology have demonstrated the benefit of erythropoiesis-stimulating agents (ESA) in the treatment of anemia. ESAs allow the improvement of QOL,of the hemoglobin level (Hb) and is a validated alternative to transfusion.

However, in hematology, if there are some specific recommendations for the use of ESAs in lymphoid pathology, there are none for myeloid disorders and in the context of autografts and allogeneic hematopoietic stem-cell transplantation (HSCT). Thus, the investigators are in particular interested in both indications: treatment of anemia in acute myeloid leukemia (AML) patients treated with chemotherapy, and the in patients receiving a myeloablative or a non-myeloablative conditioning before allogeneic HSCT, whatever type of donor and cell source.

In this context, a prospective observatory was conducted from 2006 to 2009 in the hematology department of Prof. Michallet to assess the impact of prescribing ESAs (epoetin beta and darbepoetin) for these two distinct patient populations. A significant improvement in QOL during the six-month follow- up was observed in both groups. The effectiveness of the ESA on the red cell recovery and the reduction of red blood cell transfusions was established by comparing the evolution of Hb and transfusion needs of the population under ESA to a matched population. Moreover, no significant difference in the occurrence of thromboembolic events in survival and progression-free survival was observed between the ESA group and the control group.

Observatory of the Prescription of Erythropoietin as Treatment of Anemia Induced by Chemotherapy or Allograft Conditioning Among the Patients With a Haematological Malignancy

Clinical Observatory of the Prescription of Erythropoietin as Treatment of Anemia Induced by Chemotherapy or Allograft Conditioning Among the Patients With a Haematological Malignancy

Patient's quality of life: Fact-An questionnaire

Patient's quality of life: Fact-An subscales

Patient's quality of life: Fact-G questionnaire (including physical well-being, social well-being, emotional well-being and functional well-being)

Patient's quality of life: Fact-Anemia (including Fact-Fatigue)

Hospices Civils de Lyon

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

In the research, Specialist Palliative Care was provided according to the guidelines established by Mid-Western Health Board in a Report of the National Advisory Committee on Palliative Care as well as according to recommendations of Polish Society of Palliative Medicine and Polish National Healthcare Fund. In order to ensure interdisciplinary and integrated palliative care, a team of specialists was appointed. Team members were engaged in the process of treatment of each patient during the time of the study and applied their specialist skills according to the needs of the patients

Specialist Palliative Care

Jadwiga Jośko-Ochojska, prof

Łukasz Pietrzyńsi

The aim of this prospective, observational study is the evaluation of the effectiveness of a 14-day Specialist Palliative Care therapy in participants with advanced breast cancer carried out in a stationary palliative care unit in Poland. The length of the entire study will be 36 months.

The Impact of SPC on Advanced Breast Cancer Patients

The Influence of Specialist Palliative Care on the Exacerbation of Negative Symptoms, Life Quality and Performance Status of Patients With Advanced Breast Cancer

intensification of patients negative symptoms was assessed by Edmonton Symptom Assessment System (esas)

performance status of patients was assessed by ECOG scale (Eastern Cooperative Oncology Group)

quality of life of patients of patients was assessed by quality of life uniscale (QoLU)

Silesian University of Medicine

Principal Investigator

Recurrence

Participants complete the symptom questionnaire alone. It is then counterchecked by health care professional (HCP).

Participants complete the symptom questionnaire with the help of the research nurse or assistant.

Participants complete the symptom survey alone, or with the help of a research nurse or assistant.

Edmonton Symptom Assessment Scale

After completion of the symptom questionnaire, participants asked if they preferred completing the questionnaire alone, or if they preferred to have a nurse help them answer the questions.

Interview

Eduardo Bruera, MD

The goal of this research study is to learn how easy participants think it is to complete a symptom questionnaire.

If participant agrees to take part in the study, basic information about them will be collected from their medical record (such as their age, gender, ethnicity, religion, diagnosis, marital status, educational level, performance status, and any drugs they may have taken in the past or are currently taking).

Participant will also be given a list of words and asked to read them out loud. The research nurse or assistant will write down if participant pronounced the words correctly. This should take up to 7 minutes.

Participant will then be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

* If participant is enrolled in Group 1, they will complete the symptom questionnaire alone and then a research nurse or assistant will go over their answers with them.
* If participant is enrolled in Group 2, they will complete the symptom questionnaire with the help of the research nurse or assistant.

After participant has completed the symptom questionnaire, they will be asked if they preferred completing the questionnaire alone or if they preferred to have a nurse help them answer the questions. This should take about 1 minute to answer.

Length of Study:

It should take about 15 minutes total to complete the study. Patient's participation on this study will end after they have completed the symptom questionnaire.

Additional Information:

Participant is taking part in this study alone. Participant's family members will not be in the room with them.

This is an investigational study.

Up to 128 participants will be enrolled in the study. All will take part at MD Anderson.

Edmonton Symptom Assessment Scale: Self-Completion vs. Assisted-Completion

Edmonton Symptom Assessment Scale: Time Duration of Self-Completion Versus Assisted-Completion in Advanced Cancer Patient: a Randomized Controlled Trial

Two group t-test used with significance level of 5%, a total of 128 patients (64 patients/group) will give 80% power to detect the difference of 1.5 minutes (4 minutes in Group A vs 5.5 minutes in Group B) in overall time, given a common standard deviation of 3, which corresponds to an effect size of 0.5.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High Flow Oxygen and Bilevel Airway Pressure for Persistent Dyspnea in Patients With Advanced Cancer	NCT00934128	Advanced Cancer...	Vapotherm BIPAP	18 Years -	M.D. Anderson Cancer Center
Conversion From Fast Acting Oral Opioids to Abstral®	NCT01315886	Pain	SL fentanyl	18 Years -	Orexo AB
Observatory of the Prescription of Erythropoietin as Treatment of Anemia Induced by Chemotherapy or Allograft Conditioning Among the Patients With a Haematological Malignancy	NCT02860598	Anemia Acute Myeloid L...		18 Years -	Hospices Civils de Lyon
The Impact of SPC on Advanced Breast Cancer Patients	NCT03612934	Breast Cancer Palliative Care Quality of Life Cancer, Breast	Specialist Pall...	33 Years - 91 Years	Silesian University of Medicine
The Impact of SPC on Advanced Breast Cancer Patients	NCT03612934	Breast Cancer Palliative Care Quality of Life Cancer, Breast	Specialist Pall...	33 Years - 91 Years	Silesian University of Medicine
Edmonton Symptom Assessment Scale: Self-Completion vs. Assisted-Completion	NCT02523378	Advanced Cancer...	Edmonton Sympto... Interview	18 Years -	M.D. Anderson Cancer Center
Conversion From Fast Acting Oral Opioids to Abstral®	NCT01315886	Pain	SL fentanyl	18 Years -	Orexo AB
The Impact of SPC on Advanced Breast Cancer Patients	NCT03612934	Breast Cancer Palliative Care Quality of Life Cancer, Breast	Specialist Pall...	33 Years - 91 Years	Silesian University of Medicine
Observatory of the Prescription of Erythropoietin as Treatment of Anemia Induced by Chemotherapy or Allograft Conditioning Among the Patients With a Haematological Malignancy	NCT02860598	Anemia Acute Myeloid L...		18 Years -	Hospices Civils de Lyon

Spots Global Cancer Trial Database for esas

Every month we try and update this database with for esas cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for esas

Every month we try and update this database with for esas cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for esas cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.