Symptoms and General Pathology

All Conditions

Nervous System Diseases

Recurrence

Pain

Breakthrough Pain

Neurologic Manifestations

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Fentanyl

Morphine

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Hospitalized participants asked to complete a number of surveys at baseline. Participants then receive one single dose of intravenous opioid rescue for their first episode of breakthrough pain, and then receive up to 4 doses of FSS for subsequent episodes of breakthrough pain. Initial FSS starting dose is proportional to the patient's morphine equivalent daily dose (MEDD). Symptom questionnaire completed at baseline and after last dose of FSS while hospitalized. Mental ability tests given while hospitalized 30 minutes after first dose of current pain medication, and 30 minutes after each FSS dose. At the time of discharge, if FSS was helpful in controlling participant's pain, they are then able to continue with FSS use for 1 month. Participants given study diary to document pain level, how many times FSS used, and any side effects experienced each day.

Stage 1: First Pain Episode - Single dose of breakthrough opioid given from existing PCA pump equivalent to 10% of their MEDD.

Second Pain Episode - Single dose of FSS equivalent to 16-32% of MEDD. If not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum.

Third Pain Episode (at least 4 hours after second episode) - Participant required 2 breakthrough FSS doses for the last episode of breakthrough pain, or if the effective dose has not been identified, he/she will double the last administered dose. If breakthrough pain not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum).

Stage 2: If FSS successful in hospital, upon discharge, FSS used as first choice of pain medication instead of oral pain medication for pain for up to 4 weeks.

Fentanyl Sublingual Spray (FSS)

Symptom questionnaire completed at baseline and after last dose of FSS while hospitalized. After Day 28, questionnaire completed over the phone about participant's opinion of research study.

Questionnaires

Mental ability tests given while hospitalized 30 minutes after first dose of current pain medication, and 30 minutes after each FSS dose.

Mental Ability Tests

Participants given study diary to document pain level, how many times FSS used, and any side effects experienced each day.

Study Diary

Suresh Reddy, MD

The goal of this clinical research study is to learn if an investigational dose of fentanyl sublingual spray (FSS) can help to control pain in patients with advanced cancer when given in an outpatient and inpatient setting.

Study Visits and Study Drug Administration:

This study has 2 stages. Stage 1 will be completed while you are in the inpatient unit of the hospital and Stage 2 will be completed after you are discharged from the hospital.

Stage 1:

While you are in the hospital, if you have a pain episode, the research nurse will give you a single dose of your current pain medication from your existing infusion pump. You will then be asked to rate your current level of pain . You will also be asked if you are having any side effects at 15 minutes and at 30 minutes after the dose has been administered. You will also complete the 4 tests of mental abilities after about 30 minutes.

If after 1-4 hours you have another episode of pain, you will be given a single dose of FSS. You will spray FSS under your tongue and hold it there for about 30-60 seconds before swallowing. You will be asked about your current level of pain at about 15 minutes and 30 minutes after your dose of FSS. You will also complete the 4 tests of mental abilities after about 30 minutes. If you do not feel any pain relief after 30 minutes, you will spray FSS 1 more time under your tongue and you will repeat the pain and mental ability tests.

If you still do not feel any pain relief after about 4 hours from the last dose of FSS, you will spray a double dose of FSS under your tongue up to 2 times and your pain level and mental abilities will be tested at 15 and 30 minutes after each dose.

You may receive FSS up to 4 times total while you are in the hospital.

After your last dose of FSS, you will complete a questionnaire about how your symptoms are after receiving FSS. This should take about 2 minutes to complete.

End of Stage 1:

If FSS was able to help you control your pain, you will stop taking FSS and go back to receiving your regular pain medication for the rest of your hospital stay. When you are discharged from the hospital, you will continue on to Stage 2 of the study (described below) to receive FSS for up to 4 weeks at home. Before you are sent home, you will also be prescribed pain medication to take in addition to the FSS, if needed. Your doctor will explain how to take this medication before you are discharged.

If FSS was not able to help control your pain, your participation in this study will end and you will continue to be treated with standard pain medications.

Stage 2:

If you are taking part in Stage 2, you will use FSS as your first choice of pain medication instead of oral pain medication for pain for up to 4 weeks. At any time that you have a pain episode, you will spray FSS under your tongue.

You will always have the choice of using the pain medication your doctor prescribed to you as a backup every 2 hours as needed for pain. However, it is very important that you do NOT use the oral pain medications at the same time as FSS. If you still have pain after taking FSS, you must wait at least 2 hours before using your pain medications. After 2 more hours if you have another episode of pain, you may use another dose of FSS for pain relief.

Do not take more than 4 doses of FSS each day.

You will be given a patient diary to write down each day your pain level, how many times you used FSS, and any side effects you may have. You will be called at least 2 times each week by a member of the study staff to discuss your diary and to answer any questions you may have. The study staff will also ask you which pain medication you are using besides FSS, how easy you think it is to use FSS, how effective you think FSS is, and how satisfied you are with your current pain medications. Each phone call should last about 10 minutes.

After Day 28, you will complete a questionnaire over the phone about your opinion of this research study. This should take about 5 minutes to complete.

Length of Study:

Your active participation in this study is over after you complete the last questionnaire. You will be taken off study if intolerable side effects occur or if you are unable to follow study directions.

Follow-Up:

About 30 days after your study visit, you will be called by the study staff and asked how you are feeling and about any side effects you may be having. This call should last about 10 minutes.

This is an investigational study. FSS is FDA approved and commercially available for the treatment of pain in cancer patients. It is considered investigational to use the dose of FSS used in this study and to use FSS both in inpatient and outpatient settings.

About 30 participants will be enrolled in this study. All will take part at MD Anderson.

Sublingual Fentanyl for the Management of Breakthrough Pain

A Preliminary Study of Sublingual Fentanyl for the Management of Breakthrough Pain Analgesia in Patients With Advanced Cancer

To determine the effective dose of Fentanyl sublingual spray in the management of breakthrough pain (4 episodes) in hospitalized patients with advanced cancer receiving continuous opioid infusion in which the first starting dose would be proportional to the patients Morphine Equivalent Daily Dose. It will use Alberta Breakthrough Pain assessment tool with 15 questions.

To estimate the differences in the pain response between intravenous opioid breakthrough and fentanyl sublingual spray at effective dose. Pain will be assessed in a 0-10 numeric rating scale that assesses pain intensity now, where 0=no pain at all, and 10=worst possible.

To determine the safety, tolerability, pattern of use and efficacy of Fentanyl sublingual spray in patients with advanced cancer

INSYS Therapeutics Inc

M.D. Anderson Cancer Center

Fentanyl sublingual spray was administered with a starting dose of 100 mcg up to 1600 mcg maximum for each breakthrough pain.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Married

Separated/Divorced

Marital status

Some high School

Some College

Completed College

Did not answer

Education

Colon

Gastric

Melanoma

Cholangiocarcinoma

Lymphoma

Cancer Type

Suresh K. Reddy, MD/Professor, Palliative Care Med

Data was not collected due to low accrual and early termination.

Effective Dose of Fentanyl Sublingual Spray (FSS)

Difference Between Intravenous Opioid and Fentanyl Sublingual Spray

Safety, Tolerability, Pattern of Use and Efficacy

Overall Study

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Inflammatory Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.

Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.

Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.

Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.

Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.

Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.

Residential Program

Questionnaires completed about mood, sleep, fatigue, how participant has been feeling, and their general quality of life at baseline visit, 1 month after baseline, 7 days after residential program ends, and again about 3 months later.

EEG performed at baseline with simultaneous computer testing consisting of 3 tests to check attention, short-term memory, and levels of emotions. EEG repeated 7 days after the residential program ends, and then again about 3 months later.

Electroencephalogram (EEG)

Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. Saliva testing repeated 7 days after the residential program ends, and then again about 3 months later.

Saliva Testing

For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.

Study Diary plus Actigraph

Lorenzo Cohen, PHD

The goal of this behavioral research study is to compare 2 different types of residential group programs to help researchers learn if and how well these groups may help to improve physical and emotional well-being in patients with stage IV breast cancer.

Baseline Visit:

Signing this consent form does not mean that you will be able to take part in this study. The following baseline tests will help the doctor decide if you are eligible:

* You will complete 7 questionnaires about your mood, sleep, fatigue, how you have been feeling, and your general quality of life. The questionnaires should take about 60-80 minutes to complete.
* You will have an electroencephalogram (EEG) to check your brain's electrical activity. During the EEG, a snug cap with small electrodes will be placed on your head to measure the electrical patterns coming from the brain. This is like the way a doctor listens to your heart from the surface of your skin. During the EEG, you will complete 3 tests to check your attention, short-term memory, and levels of emotions on the computer. The study staff will discuss each test in more detail with you. The EEG and tests will take about 45-60 minutes total.
* If you have not had a computed tomography (CT) scan in the last 2 months, you will have one performed to check the status of the disease. If you have had one in the last 2 months, the results will be collected from your medical records.
* You will have an electrocardiogram (EKG) to check your heart function.
* Blood (about 6 tablespoons) will be drawn for tests to measure hormones and your immune system responses. You will need to fast (not eat or drink anything except water) for 12 hours before this blood draw. You will be provided with healthy snacks after your blood draw.

The day after your baseline visit, saliva will be collected to measure the level of cortisol (a type of stress hormone) in your body. These saliva samples will be collected 4 times each day for 3 days in a row. You will collect these samples at home when you first wake up, about 45 minutes later, about 10 hours after waking up, and then at bedtime. To collect each saliva sample, you will chew on a cotton ball for a few seconds and then put the cotton in a small plastic tube. You will write down the times you took these samples. You will mail these samples back to MD Anderson in postage-paid envelopes that will be provided to you. The tubes will also be provided at no cost to you. These saliva samples will be destroyed after being studied.

Every day for the next 7 days after your baseline visit, you will fill out a diary about your sleeping habits. You will also wear a special type of wrist watch for these 7 days. The watch will collect data about your physical activity and sleeping habits. After you have worn it for 7 days, you will mail the watch and the sleep diary back to MD Anderson in postage-paid envelopes that will be provided to you.

Extended Baseline:

You will be asked to complete and provide all the same measures again 1 month after the first baseline visit.

Study Groups:

If you are found to be eligible to take part in this study and you agree, you will be randomly assigned (as in the roll of dice) to 1 of 3 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

* If you are assigned to Groups 1 or 2, you will take part in 1 of 2 types of residential group programs.
* If you are assigned to Group 3, you will receive standard cancer care without any participation in a residential group program.

If you are assigned to Groups 1 or 2, neither you nor the study staff will know what kind of residential group program you are in.

Residential Support Program Sessions (Groups 1 and 2 only):

You will take part in a 7-day offsite, residential support program in groups of about 10 participants each. On Day 5 of the retreat, you will be joined by your spouse or caregiver.

During the 7 days, you will take part in group activities, learn relaxation skills, do different cognitive activities (for example, reading, watching movies, and having group discussions), and learn about mind-body connections. You will spend 7 days and 6 nights at the residential retreat. Activities at the retreat will last about 12 hours per day with breaks, group meals, and free time to rest in the morning, afternoon and evening, or as needed.

At least 1 week before the retreat, you will be given a detailed agenda and schedule of all activities that will occur during the retreat.

Follow-Up Sessions (All Groups):

You will complete the same tests/procedures that were performed at the baseline visit within 7 days after the residential program ends and then again about 3 months later. If you are in Group 3, you will complete the same tests/procedures on the same schedule.

Length of Participation:

Your participation on this study will be over after you complete the follow-up sessions.

Depending on which study group you were assigned to, you may be able to take part in a residential program that you did NOT previously take part in. The study chair or research staff will discuss this option with you.

This is an investigational study.

Up to 100 participants and their caregivers will take part in this multicenter study. Up to 74 will be enrolled at MD Anderson.

Effects of a Group Residential Retreat on Cancer Outcomes

Participant compliance with assessments monitored as well as participation in all aspects of the intervention program. Intervention deemed feasible if ≥ 60% of enrolled couples complete all assessments and attend the assigned retreat.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sublingual Fentanyl for the Management of Breakthrough Pain	NCT02514252	Advanced Cancer...	Fentanyl Sublin... Questionnaires Mental Ability ... Study Diary	18 Years -	M.D. Anderson Cancer Center
Effects of a Group Residential Retreat on Cancer Outcomes	NCT02429544	Breast Cancer	Residential Pro... Questionnaires Electroencephal... Saliva Testing Study Diary plu...	50 Years -	M.D. Anderson Cancer Center
Effects of a Group Residential Retreat on Cancer Outcomes	NCT02429544	Breast Cancer	Residential Pro... Questionnaires Electroencephal... Saliva Testing Study Diary plu...	50 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for study diary

Every month we try and update this database with for study diary cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for study diary

Every month we try and update this database with for study diary 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 study diary 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.