Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Rare Diseases

Lung Diseases

Pain

Mesothelioma

Mesothelioma, Malignant

Respiratory Tract Diseases

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Malignant Mesothelioma

After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital.

After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital.

After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.

Progel Sealant

After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.

Talcum Powder

Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.

Pain Questionnaire

Reza J. Mehran, MD

The goal of this clinical research study is to compare Progel® (a type of surgical sealant that is made from human blood products) to the standard of care (talcum powder) to learn if one method is better than the other for preventing air leaks in patients having a pleurectomy decortication.

If participant agrees to take part in this study, they will have their pleurectomy decortication as planned. Participant will sign a separate consent for this procedure that explains the risks.

At the time of participant's surgery, sutures and staples are used to help correct air leaks, which is standard.

Then, participant 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:

* One group will have Progel® added to the surface of the lung before closing the chest.
* The other group will have talcum powder added to the surface of the lung before closing the chest.

Participant will have an equal chance of being in either group.

During the surgery, air leaks will be checked electronically and that information will be recorded.

After surgery, participant will be asked to rate their pain on a pain scale of 0-10. Participant will be asked to complete this pain scale 3 times each day while they are in the hospital.

Length of Study Participation:

After participant's surgery and their air leak is resolved, their participation in this study will be over.

This is an investigational study. The Progel® surgical sealant is FDA approved for the control of air leaks during lung surgery. It is investigational to compare the surgical sealant with the standard-of-care (talcum powder) to learn if it can reduce the number of days in the hospital after surgery.

Up to 48 participants will enrolled in this study. All will take part at MD Anderson.

Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication

A Randomized Phase III Trial to Compare the Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication for Mesothelioma or Other Pathologies

Primary outcome is T = time to resolve an air leak in the lungs, allowing the possibility that an air leak may not develop, represented by T=0.

Bard Incorporated

M.D. Anderson Cancer Center

Nervous System Diseases

Substance Related Disorders

Syndrome

Acute Pain

Neurotoxicity Syndromes

Neurologic Manifestations

Poisoning

Chemically-Induced Disorders

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

pain questionnaires

Charles L. Loprinzi, MD

RATIONALE: Gathering information over time from patients receiving paclitaxel for cancer may help doctors learn more about pain caused by paclitaxel and plan the best treatment.

PURPOSE: This clinical trial is studying acute pain caused by paclitaxel in patients with cancer.

OBJECTIVES:

* To describe the incidence and characteristics of and change in pain related to paclitaxel infusions over several courses in patients receiving paclitaxel weekly or every 2-4 weeks with or without neurotoxic chemotherapy.
* To investigate the association between paclitaxel-induced acute pain syndrome symptoms and eventual chemotherapy-induced neuropathy.
* To perform exome-sequencing analysis and identify genetic variants that predict paclitaxel- induced peripheral neuropathy.
* To identify clinical phenotypes associated with paclitaxel toxicity (i.e., acute pain syndrome and neuropathy).
* To explore whether there are any evident differences between results seen in the majority Caucasian population and the minority populations.

OUTLINE: This is a multicenter study. Patients are grouped according to paclitaxel dosing schedule (weekly vs every 2-4 weeks) and concurrent use of neurotoxic agent (yes vs no).

Blood samples are collected at baseline for correlative laboratory studies, including genetic biomarker and polymorphism studies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication	NCT02511600	Lung Diseases Mesothelioma	Progel Sealant Talcum Powder Pain Questionna...	18 Years -	M.D. Anderson Cancer Center
Acute Pain Caused by Paclitaxel in Patients With Cancer	NCT00860041	Chemotherapeuti... Neurotoxicity Pain Unspecified Adu...	pain questionna...	18 Years -	Alliance for Clinical Trials in Oncology
Acute Pain Caused by Paclitaxel in Patients With Cancer	NCT00860041	Chemotherapeuti... Neurotoxicity Pain Unspecified Adu...	pain questionna...	18 Years -	Alliance for Clinical Trials in Oncology

Spots Global Cancer Trial Database for pain questionnaires