Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Dyspnea

Respiratory Aspiration

Hematologic Diseases

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Vasoconstrictor Agents

Central Nervous System Depressants

Dexamethasone

Dexamethasone acetate

BB 1101

Cocaine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Dexamethasone 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days. In the open label phase, patients assigned to either arm asked to take Dexamethasone 4 mg orally twice a day for 7 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.

Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.

Two placebo capsules taken twice a day for 4 days, followed by one capsule twice a day for 3 days. Patient to blow into spirometry machine 1 time a day to test lung function. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires. Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.

Participants randomized to either dexamethasone or placebo for 7 days in a blinded fashion; this will be followed by an open label phase in which patients in both arms would take dexamethasone for 7 days.

Group 1 Blinded Phase: 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days.

Open Label Phase Groups 1 and 2: 4 mg by mouth twice a day for 7 days.

Group 2 Blinded Phase: Two capsules by mouth twice a day for 4 days, followed by one capsule twice a day for 3 days.

Placebo

Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.

Questionnaires

Patient to blow into spirometry machine 1 time a day to test lung function.

Spirometer

Patient called by phone 1 time each day to ask about level of shortness of breath and to remind patient to take capsules. These calls should last about 5 minutes.

Phone Calls

David Hui, MD

The goal of this clinical research study is to learn if dexamethasone can help reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve lung function and quality of life. In this study, dexamethasone will be compared to a placebo.

Dexamethasone is commonly used for treatment of nausea, tiredness, and pain. It may help patients with shortness of breath.

A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Baseline Tests:

If you are found to be eligible to take part in this study, you will have baseline tests after completing the screening questionnaires. The following tests and procedures will be performed:

* Information will be collected from your medical record about your age, sex, race, disease type, how well you are able to perform the normal activities of daily living, any drugs you are taking, and possible causes of shortness of breath.
* Your breathing rate will be measured.
* The amount of oxygen in your body will be measured using a machine that clips on your finger.
* You will blow into a device called a spirometer a few times to measure your lung function.
* You will be asked to answer 4 questionnaires. The first questionnaire asks you to rate your level of symptoms, such as pain, tiredness, sleep, appetite, depression, anxiety, and drowsiness. The second questionnaire asks about your sensation of breathing. The third questionnaire asks you to rate the intensity of your shortness of breath. The last questionnaire asks about your quality of life. These questionnaires should take a total of about 40 minutes to complete.

Study Groups:

You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:

* If you are in Group 1, you will receive dexamethasone.
* If you are in Group 2, you will receive a placebo for 7 days, then dexamethasone for 7 days.

You will have an equal chance of being assigned to either group. Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Drug/Placebo Administration:

After your baseline tests, you will be given a supply of either the study drug or the placebo to bring home.

Starting the next morning, you will take 2 dexamethasone or placebo capsules twice a day by mouth for 4 days. Then, you will take 1 tablet twice a day for 3 more days.

After the first 7 days, no matter which group you have been assigned to, you will only take 1 dexamethasone capsule twice a day for 7 more days

You should take the capsules around 8 o'clock in the morning and 4 o'clock in the afternoon. You should take the capsules with food and 8 ounces of water.

You will also receive a portable spirometer to test your lung function. You should blow into the machine 1 time a day.

Study Visits/Calls:

On Days 7 and 14, you will return to the clinic or be called by phone. You should bring your capsule boxes with you if you come to the clinic, or have them with you if you are called so the study staff can count the number of capsules. The following tests and procedures will be performed:

* You will be asked to complete the same 4 questionnaires you completed during your baseline tests.
* You will also be asked about any side effects you may be having and if you think the study drug is helping your shortness of breath.
* You will blow into a spirometer to measure your lung function.

During the 14 days you will be taking either the study drug or the placebo on the study, you will be called by phone 1 time each day to ask you about your level of shortness of breath and to remind you to take the capsules. These calls should last about 5 minutes.

Length of Study:

You may continue taking the study drug for up to 14 days, as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if intolerable side effects occur or if you are unable to follow study directions.

Your participation on the study will be over when you have completed the follow-up calls and visit.

This is an investigational study. Dexamethasone is FDA approved and commercially available for the treatment of pain, nausea and tiredness. Its use to help control shortness of breath is investigational.

Up to 40 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Dexamethasone Dyspnea Study

A Preliminary Study of Dexamethasone for Dyspnea in Cancer Patients

Number of participants who completed the dyspnea numeric rating scale on Day 7

The Secondary outcome is the Edmonton Symptom Assessment System dyspnea intensity which is measured with a single 11-point numeric rating score that ranges between 0 and 10, with 0 being no symptom at all and 10 being worst possible. We measured the change in Edmonton Symptom Assessment System dyspnea numeric rating score (average 24 h) form baseline to Day 4, Day 7 and Day 14.

Secondary outcome was dyspnea intensity 'now' using a dyspnea numeric rating scale that ranges from 0 (no shortness of breath) to 10 (worst possible shortness of breath). We measured the change in Dyspnea numeric rating score form baseline to Day 4, Day 7 and Day 14.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, consists of 30 items that encompasses three symptom scales (pain, fatigue, nausea/vomiting), six single-item symptom items, five functional scales (physical, cognitive, role, emotional, and social), and one scale assessing global health status/quality of life. Each scale comprises 2-5 items. All items have four response categories (1=not at all, 2=a little, 3=quite a bit, 4=very much), except for two items assessing overall health status/quality of life, which use a seven-point scale. This questionnaire includes one item to assess dyspnea during the past week ("Were you short of breath?). The four-point ordinal scale was transformed to 0-100 points using a formula, higher scores indicate worse dyspnea. We measured the change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea score form baseline to Day 4, Day 7 and Day 14.

M.D. Anderson Cancer Center

As open label medication (Dexamethasone capsules 4 mg twice daily for 7 days) was given to both 'Intervention group' and 'Controlled group' after the initial study medication, we did not measure or looked for the adverse events for open label medication (the last 7 days). We measured the adverse events only for the first 7 days when the intervention and controlled group received 2 different study medications.

Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.

Intervention Group (Dexamethasone)

Received Placebo for 7 days, It was followed by dexamethasone capsule 4 mg twice daily for 7 days.

Controlled Group (Placebo)

Received Dexamethasone capsule 8 mg twice daily for 4 days, then 4 mg capsule twice daily for 3 days. It was followed by dexamethasone capsule 4 mg twice daily for 7 days.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

High School or less

College and above

Education

Mesothelioma

Non-small cell lung cancer

Small cell lung cancer

Other

Cancer Type

Localized

Locally advanced

Metastatic/recurrent

Cancer Stage

COPD

Asthma

Comorbidities

Data included all participants who were randomized.

David Hui, MD/ Associate Professor, Palliative Care Medicine

Baseline Analysis included all randomized participants, 20 participants in intervention arm and 21 participants in control arm

Number of Participants Who Completed the Dyspnea Numeric Rating Scale

Day 4

Day 7

Day 14

The number of participants varied by milestone study days (Baseline (38 participants) , Day 4 (30 participants) , Day 7 (30 participants) and Day 14 (28 participants) who completed the Edmonton Symptom Assessment Questionnaire.

Edmonton Symptom Assessment System Dyspnea Score

The number of participants varied by milestone study days (Baseline (38 participants), Day 4, (35 participants) Day 7 (35 participants), and Day 14 (26 participants) who completed the Dyspnea Numeric Rating Score Questionnaire.

Dyspnea Numeric Rating Score (Now)

The number of participants varied by milestone study days (Baseline (38 participants), Day 4 (30 participants), Day 7 (29 participants), and Day 14 (28 participants) who completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-20 Dyspnea.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core- 30 Dyspnea

Overall Study

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

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.

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

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)

Neoplasms

Skin and Connective Tissue Diseases

Lung Neoplasms

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Acupuncture

The purpose of this study is to determine whether acupuncture is effective in relieving shortness of breath among breast and lung cancer patients.

Acupuncture for Shortness of Breath in Cancer Patients

National Cancer Institute (NCI)

National Center for Complementary and Integrative Health (NCCIH)

Recurrence

Participants receive air through VapoTherm for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through bilevel positive airway pressure (BiPAP) for up to 30 minutes, followed by 30 minutes using non-rebreather mask.

Participants receive air through bilevel positive airway pressure (BiPAP) for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through VapoTherm for up to 30 minutes, followed by 30 minutes using non-rebreather mask.

Participants receive air through Non-Rebreather Mask for 1 hour, and then on an "as needed" basis for up to 4 hours. Participants then receive air through VapoTherm for up to 30 minutes, followed by 30 minutes using bilevel positive airway pressure (BiPAP).

Oxygen Delivery Devices

2 Questionnaires completed at baseline taking about 10 minutes to complete. At end of visit, questionnaire completion taking about 5 minutes to complete.

The goal of this clinical research study is to learn if 3 breathing devices reduce feeling short of breath in cancer patients. Researchers also want to learn if these devices can help to control shortness of breath.

Device A is designed to 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.

Device B is 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.

Device C is designed to deliver air in and out of the lungs. The air is given through a mask, and the amount of air can be set to different levels.

Study Groups and Device Use:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups:

* If you are in Group 1, you will receive air through Device A for 1 hour, and then on an "as needed" basis for up to 4 hours. Then you will receive air through Device B for up to 30 minutes, followed by 30 minutes using Device C.
* If you are in Group 2, you will receive air through Device B for 1 hour, and then on an as needed basis for up to 4 hours. Then you will receive air through Device A for up to 30 minutes, followed by 30 minutes using Device C.
* If you are in Group 3, you will receive air through Device C for 1 hour, and then on an as needed basis for up to 4 hours. Then you will receive air through Device A for up to 30 minutes, followed by 30 minutes using Device B.

The study staff will help you use the devices. The maximum time allowed using the 3 devices is 6 hours total.

During the "as needed" use period (4 hours), you will switch between the device you were assigned to and the same air delivery device and oxygen level that you were using just before you started the study.

Study Visit:

During your study visit, the following tests and procedures will be performed:

* From your medical record, the study staff will collect information about your age, sex, race, disease type, how well you are able to perform the normal activities of daily living, any drugs you are taking, and possible causes of shortness of breath.
* You will complete 2 questionnaires. The first asks about breathing symptoms, and the second asks about other symptoms you may be having. It should take about 15 minutes to complete these questionnaires.
* Your heart rate, breathing rate, and blood pressure will be recorded.
* The level of air you breathe out will be recorded using a measuring device on your chest.
* Before and after using the devices, you will be asked how hard it is to catch your breath and about any side effects you may be having.
* At the end of the visit, you will fill out a questionnaire that asks about which device you prefer. It should take about 5 minutes to complete this questionnaire.

Length of Study:

You will be on this study for up to 6 hours. You will be taken off study and the device will be stopped if intolerable side effects occur while using a study device.

This is an investigational study. The 3 breathing devices are commercially available and FDA approved for delivering oxygen when medically needed, including in cancer patients. It is investigational to collect information from patients to rate how well the study devices may affect shortness of breath.

Up to 90 patients will be enrolled in this study. All will be enrolled at MD Anderson.

BiPAP-Vapotherm RCT

Novel Oxygen Delivery Modalities for Refractory Dyspnea in Patients With Advanced Cancer

Maximal inspiratory pressure measured at baseline, at end of the first hour, and after 4 hours of as-needed intervention using the NS 120-TRR negative inspiratory force monitor. Five consecutive efforts will be recorded, with a 1-minute pause between each effort (Ha-rik-Khan et al. 1998). Participants asked to rank the breathing devices based on their (1) efficacy in helping them to breathe, (2) comfort, and (3) ease of use on a numeric rating scale from 0 (best) to 10 (worst).

Behaviors and Mental Disorders

Anxiety Disorders

Depression

Depressive Disorder

Pain

Participants will be given a list of VR applications to choose from. They will then be given instructions by a research assistant (approximately 10 minutes) on how to use the selected application they have chosen, as well as time for any questions they may have before starting their VR experience. They will then have an approximately 30-minute session of that VR experience. They may or may not be accompanied by a family member or significant other and will also have a research assistant available to aid them in any difficulties experienced during the VR experience.

The intervention is a Virtual Reality experience within a selected application using an Oculus Quest 2 ©, as previously in the relevant intervention arm.

Virtual Reality

Patricia Valcke, MD

Natan Veinberg, MD

Patricia Valcke

Natan Veinberg

The objective of this study is to determine whether VR can ameliorate symptoms for palliative care patients within a hospice setting. We also aim to verify the efficacy with a larger sample size than previously shown, as well as extend the population to include non-cancer patients receiving Hospice care. We will further attempt to delineate whether there is a sustainability of symptomatic improvement one week after VR experiences.

Potential candidates will be provided with our assent and consent information form and the study will be explained to them in detail prior to gaining consent. As per standard practice at The Hospice of Windsor \& Essex County, palliative care ESAS symptoms will be measured at baseline during the week prior to the VR experience. The mean of these pre-VR scores will be calculated as a baseline, optimally 3 separate ESAS scores in the preceding week. ESAS symptoms and expectations/satisfaction will then be measured immediately before and after the VR experience. An average set of ESAS scores will then be calculated in the same manner for one week post VR as per baseline pre-VR scores above.

We expect to find a decrease in Palliative Care symptoms after the intervention of a VR experience.

ESAS scores for 5 key symptoms (pain, shortness of breath, depression, anxiety, and well-being) and qualitative question(s) will be asked verbally by one of the investigators and recorded on an ipad directly into the Qualtrics form, before and after the VR session. Vital signs (blood pressure, heart rate, respiratory rate) will also be measured before and after the VR session. Participants will be given a list of VR applications to choose from. They will then be given instructions by a research assistant (approximately 10 minutes) on how to use the selected application using Oculus Quest 2 they have chosen, as well as time for any questions they may have before starting their VR experience. They will then have an approximately 30-minute session of that VR experience. They may or may not be accompanied by a family member or significant other and will also have a research assistant available to aid them in any difficulties experienced during the VR experience.

Virtual Reality for Improving Symptoms in Palliative Care

Currently, there is no plan to make individual participant data (IPD) available to other researchers.

The primary outcome of this study will be a significant difference in change of ESAS score for 5 key symptoms (pain, shortness of breath, depression, anxiety, and well-being) immediately before and after a VR experience.

The first secondary outcome of this study will be a significant difference between the mean of the 1-week pre-VR and the mean of the 1-week post-VR ESAS scores for 5 key symptoms (pain, shortness of breath, depression, anxiety, and well-being). For more objective evaluation of pain and distress we will also be measuring vitals immediately before and immediately after each VR experience.

For more objective evaluation of pain and distress, the investigators will be measuring blood pressure to compare the Mean Arterial Pressure (MAP; mmHg) immediately before and immediately after each VR experience.

For more objective evaluation of pain and distress, the investigators will be measuring Heart Rate (HR; beats per minute \[bpm\]) immediately before and immediately after each VR experience.

For more objective evaluation of pain and distress, the investigators will be measuring Respiratory Rate (RR; breaths per minute \[brpm\]) immediately before and immediately after each VR experience.

Western University, Canada

Adjunct Professor, Specialist Palliative Care Consultant, Western University, Schulich School of Medicine and Dentistry

Adjuvants, Anesthesia

Analgesics

Fentanyl

Morphine

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Fentanyl subcutaneously (SQ) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test, and 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete.

Normal saline 0.9% preservative free SQ 15 minutes before walk test, and 6 minute walk test at baseline and 15 minutes after Placebo. Two (2) Questionnaires completed at baseline taking about 10 minutes to complete, and one completed after study visit taking about 5 minutes to complete.

Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before 6 minute walk test.

Normal saline 0.9% preservative free SQ 15 minutes before walk test.

6 minute walk test at baseline and 15 minutes after Fentanyl or Placebo.

Walking Tests

Questionnaires completed at baseline (two) and after study visit (one) taking about 5 ot 10 minutes to complete.

The goal of this clinical research study is to learn if fentanyl given under the skin can reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve your physical function. In this study, fentanyl will be compared to a placebo.

Fentanyl is commonly used for treatment of cancer pain. It is believed to help patients with their shortness of breath as well.

A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

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 either receive fentanyl or placebo. You will have an equal chance of being assigned to either group.

Study Drug/Placebo Administration:

Before you receive the study drug/placebo, you will walk back and forth in an indoor corridor for up to 6 minutes. You may feel out of breath or become exhausted. You may slow down, stop, and rest at any time you need to.

After that, you will sit down and rest (for up to 1 hour). During this time, the study drug/placebo will be prepared.

You will then be given a study drug/placebo shot under the skin in your arms or legs. You will then wait for another 15 minutes and repeat the walking test.

Study Visit:

During your study visit, the study staff will collect information from your medical record about your age, sex, race, disease type, how well you are able to perform the normal activities of daily living, any drugs you are taking, and possible causes of shortness of breath.

You will also complete 2 walking tests. Before the walk tests, you will complete 2 questionnaires. One (1) of them asks about any breathing symptoms you may be having, and the other asks about any other symptoms you may be having. It should take about 10 minutes to complete these questionnaires.

Before and after each walk test, the study staff will record your heart rate, breathing rate, and the level of air breathed out using a measuring device that will be clipped onto your finger. The study staff will also ask you questions about how hard it is to catch your breath and your level of tiredness.

During each walk test, you will be asked about how hard it is to catch your breath. The distance you walked and how often and for how long you stopped will be recorded. Before and after the second walk test, the study staff will ask you about any side effects from the study drug/placebo that you may be having.

During the rest period between the 2 walk tests, you may be asked how hard it is to catch your breath several times.

At the end of the study visit, you will fill out 1 questionnaire that asks if you think the study drug/placebo is helping you, and how satisfied you are with the study. It should take about 5 minutes to complete the questionnaire.

Length of Study:

You will be on this study for up to 100 minutes.You will be taken off study if intolerable side effects occur during the study.

This is an investigational study. Fentanyl is FDA approved and commercially available for the treatment of pain. It's use to help with shortness of breath is investigational.

Up to 20 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Breakthrough Dyspnea Fentanyl Study in Cancer Patients

Effects of Prophylactic Subcutaneous Fentanyl on Exercise-Induced Breakthrough Dyspnea in Cancer Patients: A Preliminary Double-Blind, Randomized Controlled Trial

Retention rate is defined as the percentage of subjects able to complete the study.

Participants receive either Fentanyl subcutaneous (SQ) 15 minutes before walking test, or Placebo (SQ) 15 minutes before walking test. During the study, trained research staff perform study assessments and monitor participant carefully throughout the study period. Six-minute walk tests were carried out following guidelines from the American Thoracic Society. The intensity of dyspnea at 0, 1, 2, 3, 4, 5 and 6 minute of each walk test were assessed using a validated numeric rating scale (NRS) ranging from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath") and every 5 minutes during the rest period.

Ambulatory patients with breakthrough dyspnea performed a baseline 6 minute walk test (6MWT), and then received either subcutaneous fentanyl or placebo 15 minutes before a second 6MWT. The change in walk distance was documented between the first and second 6MWT.

Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Fentanyl.

Normal saline 0.9% preservative free SQ 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Placebo.

Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.

Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.

Age, Categorical

The small sample size means findings are susceptible to random errors and regression to the mean.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dexamethasone Dyspnea Study	NCT01670097	Advanced Cancer... Hematologic Dis... Solid Tumors	Dexamethasone Placebo Questionnaires Spirometer Phone Calls	18 Years -	M.D. Anderson Cancer Center
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
Acupuncture for Shortness of Breath in Cancer Patients	NCT00067691	Lung Neoplasms Breast Neoplasm...	Acupuncture	18 Years -	National Center for Complementary and Integrative Health (NCCIH)
BiPAP-Vapotherm RCT	NCT01518140	Advanced Cancer...	Oxygen Delivery... Questionnaires	18 Years -	M.D. Anderson Cancer Center
BiPAP-Vapotherm RCT	NCT01518140	Advanced Cancer...	Oxygen Delivery... Questionnaires	18 Years -	M.D. Anderson Cancer Center
Virtual Reality for Improving Symptoms in Palliative Care	NCT05197894	Cancer and Non-...	Virtual Reality	18 Years -	Western University, Canada
Breakthrough Dyspnea Fentanyl Study in Cancer Patients	NCT01515566	Advanced Cancer... Dyspnea	Fentanyl Placebo Walking Tests Questionnaires	18 Years -	M.D. Anderson Cancer Center
High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients	NCT02932332	Cancer	High-flow Oxyge... Low-flow Oxygen High-flow Air Low-flow Air	18 Years -	M.D. Anderson Cancer Center
Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea	NCT01832402	Advanced Cancer...	Fentanyl Pectin... Placebo Nasal S... Walk Test Questionnaires Mental Ability ...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for shortness of breath