Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Behaviors and Mental Disorders

Lung Neoplasms

Pleural Effusion, Malignant

Pleural Effusion

Pleural Diseases

Respiratory Tract Diseases

Quality of Life

19 question M. D. Anderson Symptom Inventory (MDASI) before pleural effusion treatment and at each follow-up visit, takes about 5 minutes to complete each time.

MDASI Questionnaire

David Ost, MD

The goal of this clinical research study is to compare 2 different methods for treating a pleural effusion. Researchers also want to learn how the treatment you receive effects your quality of life (your ability to do the things you like to do and how happy you feel.

If you agree to take part in this study, you may be asked to fill out a questionnaire called the MD Anderson Symptom Inventory (MDASI) before your scheduled pleural effusion treatment procedure, 24 hours after your procedure, and then weekly for the next 4 months. During this time, a member of the study staff or a computer system will call you at home on your desired day and time to complete the questionnaire. The MDASI for lung-related symptoms has 22 questions about the possible symptoms caused by the disease, and how the symptoms may affect the activities of your daily life, which you will rate on a scale of 0-10. The MDASI will take about 5 minutes to complete each time.

You will also complete 2 questionnaires called the SF6D Patient Self Assessment and Borg Scale before your scheduled pleural effusion treatment procedure, 2 weeks later, and then 1 time a month for 1 year. These questionnaires are part of your standard of care. There are 7 questions total about how the symptoms may affect the activities of your daily life. If you are not in the clinic, a member of the study staff will call you at home on your desired day and time to complete the questionnaires. The questionnaires should take about 5 minutes total to complete each time.

Your information will be stored in a password-protected database for use in future research related to cancer for up to 5 years after the study is completed.

Before any of your information that is stored in the database can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your data from this bank, must first be approved by the IRB.

Your information will be given a code number so that none of your personal identifying information will be directly linked to your information. Only the researcher in charge of the database will have access to the code numbers and be able to link the information in the database back to you. Other researchers who use the database will not be able to link your information or file back to you.

This is an investigational study. Up to 445 participants will be enrolled at MD Anderson.

Pleural Catheters Versus Thoracoscopic Pleurodesis

Comparative Effectiveness of Indwelling Pleural Catheters Versus Thoracoscopic Pleurodesis for Treatment of Malignant Pleural Effusions

Quality-adjusted time to death (measured as QALYs) for two patient groups (indwelling pleural catheters and thoracoscopy), calculated using Brazier's SF-6D utility measure described to determine utilities, then integrating utilities over time to arrive at quality-adjusted survival for each patient.

M. D. Anderson Symptom Inventory (MDASI) symptoms questionnaire: 19 questions about symptoms rated on a scale of 1-10.

M.D. Anderson Cancer Center

Pleural Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Fentanyl

Doxycycline

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Anti-Bacterial Agents

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter.

After the IPC is removed, participant is called one time each month by study staff to check on their status.

Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter.

After the IPC is removed, participant is called one time each month by study staff to check on their status

Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.

Questionnaires

Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.

Fentanyl Patch

Fentanyl 50 mcg given by vein prior to catheter draining.

Fentanyl (IV)

Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.

Saline

Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.

After the IPC is removed, participant is called one time each month by study staff to check on their status.

Phone Calls

The goal of this clinical research study is to compare indwelling pleural catheters (IPC) in combination with saline (the current standard of care) versus IPC in combination with doxycycline as treatment for pleural effusions.

IPC Placement and Placement Follow-Up:

Before the IPC is inserted, you will complete 2 questionnaires about your quality of life and any symptoms you may have. It should take no more than 15-20 minutes to complete. You will also have a chest x-ray and you will rate your pain on a scale of 1-10. These tests are all part of your standard of care and can be explained to you in more detail by your doctor. You will be required to sign a separate consent form in order to have the IPC placed. Your doctor will give you detailed instructions about the IPC placement procedure, including its risks.

After the IPC is placed, the doctor will give you a prescription for a fentanyl patch to help control pain. The study staff will tell you how and when to wear the fentanyl patch and about any side effects that are associated with fentanyl.

About 5 days (+/- 2 days) after the IPC has been placed, you will have a clinic visit where you will be checked up on as part of your standard of care. It is important that you wear your fentanyl patch in the morning before this visit. At this clinic visit, the results of a previously performed chest x-ray will be reviewed, you will be asked to rate your pain on a scale of 1-10, and you will be asked how much fluid has drained from your catheter.

Based on the results of the above Day 5 check-up, if you are found to be ineligible to receive the study drug, the fentanyl patch will be taken off and you will be followed as part of your usual care. However, you will still considered to be on study and you will be followed the same as a participant who receives the study drug.

If you are found to be eligible to receive the study drug, you will receive fentanyl by vein over a few minutes, if needed to help control your pain. The study staff will then begin to drain your catheter and either doxycycline or saline (described below) will be placed in the catheter. The catheter will be capped for 1 hour and then drained again.

To determine if you will receive doxycycline or saline, you will 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 you are in Group 1, you will receive doxycycline.
* If you are in Group 2, you will receive saline.

Neither you nor the study doctor will know if you are receiving doxycycline or saline. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Length of Study Participation:

You will receive doxycycline or saline 1 time on this study. Your participation on this study will be over if you withdraw consent or the study closes, whichever takes place first.

Follow-Up:

Between 10-14 days after you have received either doxycycline or saline, you will come to the clinic as part of your usual standard of care so the doctor can check your IPC for possible leaking, infection, to see how much fluid has drained, and to remove any sutures. The catheter may be removed if you have it is leaking or shows signs of infection. You will continue to have this visit 1 time each month as part of your standard of care until the catheter is removed. During each of these visits:

* You will have a chest x-ray to check the status of your lungs.
* You will complete the same 2 questionnaires that you completed before your IPC was placed.

Long-Term Follow-Up:

One (1) time each month after the IPC is removed, you will be called and asked how you are doing, if you are having any side effects, if the disease has come back, and about your overall quality of life. Some of this information may be collected from your medical record. Each phone call should last about 5-10 minutes.

This is an investigational study. Doxycycline is FDA approved and commercially available for the treatment of different types of infections and pleural effusions. It is considered investigational to compare doxycycline to saline to treat pleural effusions.

Up to 250 participants will take part in this study. All will be enrolled at MD Anderson.

Indwelling Pleural Catheter With Either Doxycycline or Saline at Day 7 for Pleurodesis

A Double Blind Randomized Controlled Trial of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions

This outcome will be analyzed by cause-specific hazard Cox model with treatment group as a covariate. Whenever a catheter is removed the cause for removal will be documented. For the analysis causes will include removal due to decreased drainage (i.e. as per plan) as well as removal due to complications (e.g. infection, empyema, and refractory pain) or other reasons (e.g. catheter plugged but no complication to the patient, patient preference without a complication).

Due to slow accrual and the design of the study the protocol was terminated and Adverse Events was not collected.

Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter. After the IPC is removed, participant is called one time each month by study staff to check on their status. Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.

Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.

Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining.

Saline: Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.

Phone Calls: After the IPC is removed, partici

Indwelling Pleural Catheters (Randomized to Saline)

Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter.

After the IPC is removed, participant is called one time each month by study staff to check on their status. Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.

Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.

Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining.

Doxycycline: Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.

Phone Calls: After th

Indwelling Pleural Catheters Plus Doxycycline (Randomized to R

Indwelling Pleural Catheters (IPC) (Randomized to Saline)

IPC Plus Doxycycline (Randomized to Rx Arm)

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

2 participants withdrew before randomization

Due to slow accrual and the design of the study the protocol was terminated and no analysis or adverse event was reported.

Ost,David,M.D. / DOST@MDANDERSON.ORG

Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Saline in the catheter.

After the IPC is removed, participant is called one time each month by study staff to check on their status.

Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.

Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.

Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining. Saline: Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.

Phone Calls: After the IPC is removed, partici

Indwelling Pleural Catheter (IPC) + Saline

Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Doxycycline. Participant given a Fentanyl patch which should be worn at follow up visit 5 days after IPC placement. Fentanyl patch then be removed and Fentanyl by vein given prior to catheter draining. Study staff drains the IPC and places Doxycycline in the catheter.

After the IPC is removed, participant is called one time each month by study staff to check on their status Questionnaires: Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.

Fentanyl Patch: Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.

Fentanyl (IV): Fentanyl 50 mcg given by vein prior to catheter draining. Doxycycline: Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.

Phone Calls: After th

Indwelling Pleural Catheter (IPC) + Doxycycline

Due to slow accrual and the design of the study the protocol was terminated. No data was collected and no analysis was done.

The Primary Outcomes of Interest Will be Time to Catheter Removal.

Due to slow accrual and the design of the study the protocol was terminated and no analysis was done.

Assessment of Symptom Burden, Pleurodesis Efficacy, Complications, Health Care Resource Utilization, the Need of Hospitalization for Pain Control, Pain Free Days and Mortality

On Day 5, Fentanyl patch 12 mcg/hr placed if not already on, Fentanyl 50 mcg IV given, drain maximally, saline instilled, catheter capped for 1 hour and then re-drain. Pain will assess using a Visual Analogue Scale (VAS) as well, patient discharged home.

Symptom and quality of life questionnaires will be completed at baseline, at 10 - 14 days and each month for 12 months as well as recurrence status defined as recurrent effusion on the same side requiring intervention will be documented.

On Day 5, Fentanyl patch 12 mcg/hr placed if not already on, Fentanyl 50 mcg IV given, drain maximally, doxycycline instilled, Catheter is capped for 1 hour and then re-drain. Pain will assess using a Visual Analogue Scale as well, patient discharged home.

Symptom and quality of life questionnaires will be completed at baseline, at 10 - 14 days and each month for 12 months as well as recurrence status defined as recurrent effusion on the same side requiring intervention will be documented.

Indwelling Pleural Catheters+Doxycycline (Randomized to Rx Arm

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Pharmaceutical Solutions

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Aldesleukin

Methotrexate

Interleukin-2

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Analgesics, Non-Narcotic

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Folinic Acid

Folate

Vitamin B9

Patients are first treated with microparticles packaging methotrexate (MPs-MTX) via intrapleural infusion four times on day5,6,7,8 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), ORR is assessed.

MPs-MTX: 5 U of MPs-MTX containing a total dose of more than 25μg of MTX dissolving in 50ml of physiological saline solution

Patients are first treated with rhIL-2 via intrapleural infusion three times on day5,8,11 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), ORR is assessed.

rhIL-2: 2 million IU of rhIL-2 dissolving in 50ml of physiological saline solution

microparticles packaging methotrexate (MPs-MTX)

recombinant human interleukin-2(rhIL-2)

Fei Ma, MD

This is a prospective, open-label , multicenter randomized controlled trial, with 248 cases in 50 centers planned for a period of 2 years. The aim of the study is to evaluate the safety and effectiveness of microparticles packaging chemotherapeutic drugs (MPCD) therapy on the treatment of malignant pleural effusion (MPE) in patients with advanced lung cancer or breast cancer.

After obtaining informed consent, patients who meet the eligibility criteria will be randomly assigned 1:1 to treatment either with MPCD or recombinant human interleukin-2(rhIL-2) for injection. Randomization is stratified by tumor type and previous treatment. Patients in the MPCD group are first treated with microparticles packaging methotrexate (MPs-MTX) via intrapleural infusion four times on day5,6,7,8 and then undergo chemotherapy 1 cycle from day12. Patients in the control group are first treated with rhIL-2 via intrapleural infusion three times on day5,8,11 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), the efficacy is assessed according to the WHO (1997) Response Evaluation Criteria In MPE and the evaluation methods mainly include physical examination, ultrasound and computed tomography (CT). The patients will be monitored by telephone every three months.

Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion

Safety and Effectiveness of Microparticles Packaging Chemotherapeutic Drugs(MPCD) Therapy on the Treatment of Malignant Pleural Effusion

Percentage of patients whose pleural effusion completely recover or reduce by more than 50% for more than 4 weeks

Time from the date of first receive treatment to the date of first documented progression or date of death from any cause whichever came first

Time from the date of first receive treatment to the date of death

The change of the level of tumor markers(CEA,CA125) in blood and pleural effusion before and after treatment

Routine, biochemistry and cytological examination of pleural effusion

Peking Union Medical College

Deputy Director of Oncology Medicine

Symptoms and General Pathology

Recurrence

Intrapleural Catheters (IPC) drained every day

IPC drained daily (Group 1) or 3 times per week (Group 2)

Intrapleural catheter (IPC) drained

IPC placed in chest cavity to drain excess fluid

IPC Placement

Chest X-Rays at 3 and 6 month follow up visits

Chest X-Ray

Carlos A. Jimenez, MD

The goal of this clinical research study is to learn if draining the IPC every day is better at than draining it 3 times a week.

An IPC is a silicone (rubberlike) tube that is inserted into the chest cavity to drain excess fluid that is in your chest. At MD Anderson, patients are told to drain their IPC every day. At other institutions, patients are told to drain their IPC less often.

Before IPC Placement:

Before you can have the IPC inserted, the following tests and procedures will be performed to help the doctor decide if you need to have an IPC inserted:

* You will perform a 6 minute walk test to learn your check your breathing ability and fatigue level. To perform the walk test, you will be asked to walk as far as possible around cones on a flat indoor course that is about 40 yards long. You will walk at your own pace and can take breaks at any time if necessary.
* After signing this consent, you will fill out 2 questionnaires asking questions about how you feel and any symptoms you may have. These questionnaires will take about 20-30 minutes to complete.

IPC placement:

You will have an IPC placed to drain the fluid in your chest cavity. You will be given a separate consent for to sign for this procedure and your doctor will give you detailed instructions regarding the procedure itself.

Study Groups:

A chest x-ray will be performed right after the IPC placement. You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups, after your chest x-ray or the following day when you return to clinic for follow up. Group 1 will have their IPC drained every day, and Group 2 will have their IPC drained 3 times a week (Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday). You will be given detailed instructions on when and how to drain your catheter.

Follow-Up Visits:

Two (2) weeks after you receive the IPC, you will return to the clinic for a follow-up visit so the doctor can check your IPC for possible leaking, infection, and see how much pleural fluid has drained. After the follow-up visit at 2 weeks, you will come into the clinic every 4 weeks until your IPC is removed. During each follow-up visit the following tests and procedures will be performed to see how your condition has changed:

* You will have a chest x-ray to see if the amount of pleural fluid has decreased and to see if your lung has re-expanded.
* You will perform the 6 minute walk test.
* You will complete the same 2 questionnaires.
* The IPC will be drained.

After the IPC is removed, at 3 and 6 months, you will have follow-up visits at M. D. Anderson or at your local doctor's office. At these visits you will have chest x-rays to see if the pleural fluid has come back or not.

The study personnel will contact you by phone, email or mail periodically during the study and at 3 months and 6 months after the IPC has been removed to check on your status. The phone calls, email, or mail follow-up will take about 5-10 minutes to complete. You will be asked how you are doing and if you have any questions or concerns that you may want to discuss with the your doctor. You will also be asked if you have had a chest x-ray since being off study. If you have had an x-ray, you will be asked to share the results with the study doctor.

This is an investigational study.

Up to 250 patients will take part in this study. All will be enrolled at MD Anderson.

Intrapleural Catheter Daily Versus Three Times a Week Drainage

Effectiveness of Daily Versus Three Times a Week Drainage After Placement of Intrapleural Catheters for the Palliative Management of Pleural Effusions Associated With Malignancies

Time to pleurodesis (TTP), defined as the time from catheter insertion to catheter removal.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pleural Catheters Versus Thoracoscopic Pleurodesis	NCT01117740	Lung Cancer	MDASI Questionn...	18 Years -	M.D. Anderson Cancer Center
Indwelling Pleural Catheter With Either Doxycycline or Saline at Day 7 for Pleurodesis	NCT02623959	Advanced Cancer... Malignant Pleur...	Questionnaires Fentanyl Patch Fentanyl (IV) Saline Doxycycline Phone Calls	18 Years -	M.D. Anderson Cancer Center
Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion	NCT04131231	Lung Cancer Breast Cancer Malignant Pleur...	microparticles ... recombinant hum...	18 Years - 80 Years	Peking Union Medical College
Pleural Catheters Versus Thoracoscopic Pleurodesis	NCT01117740	Lung Cancer	MDASI Questionn...	18 Years -	M.D. Anderson Cancer Center
Pleural Catheters Versus Thoracoscopic Pleurodesis	NCT01117740	Lung Cancer	MDASI Questionn...	18 Years -	M.D. Anderson Cancer Center
Intrapleural Catheter Daily Versus Three Times a Week Drainage	NCT00761618	Advanced Cancer Pleural Effusio...	Intrapleural ca... IPC Placement Chest X-Ray	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for mpe

Every month we try and update this database with for mpe 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 mpe

Every month we try and update this database with for mpe 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 mpe 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.