Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Nausea

Vomiting

Postoperative Nausea and Vomiting

Breast Diseases

Skin Diseases

Signs and Symptoms, Digestive

Postoperative Complications

Antiemetics

Dermatologic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Anti-Allergic Agents

Central Nervous System Depressants

Emetics

Ondansetron

Dexamethasone

Dexamethasone acetate

BB 1101

Diphenhydramine

Promethazine

Famotidine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Antacids

Anti-Ulcer Agents

Histamine

Histamine H2 Antagonists

Histamine phosphate

Histamine Antagonists

Histamine H1 Antagonists

Participants receive light electrical stimulation to the wrist area during surgery. Participants also receive standard of care drugs to reduce post-operative nausea and vomiting (PONV).

Questionnaire completed about participant's pre-treatment expectations and their nausea about 15 minutes after they wake up after surgery, then every 30 minutes until they leave the clinic.

Participants receive standard of care drugs to reduce post-operative nausea and vomiting (PONV).

Questionnaire completed about participant's pre-treatment expectations and their nausea about 15 minutes after they wake up after surgery, then every 30 minutes until they leave the clinic.

Electrical stimulation to the wrist initiated at 1mHz, 1 pulse/second using two leads on a nerve stimulator. Stimulation continued throughout the breast surgery.

Electrical Stimulation

Zofran

Phenergan

Pepcid

Questionnaire completed about 15 minutes after participant wakes up after surgery, then every 30 minutes until they leave the clinic. It should take about 2 - 3 minutes to complete the questionnaire.

Questionnaire

Alicia M. Kowalski, MD

The goal of this clinical research study is to learn if light electrical stimulation to the wrist area during surgery is feasible in women having breast surgery.

Study Groups:

If you are eligible to take part in this study, 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 light electrical stimulation to the wrist area during surgery. You will also receive standard of care drugs to reduce PONV. If you have nausea or you are vomiting after surgery, you will receive additional standard of care drugs for those symptoms. You may ask the study staff for information about how the drugs are given and their risks.

If you are in Group 2, you will receive standard of care drugs to reduce PONV only (you will not receive electrical stimulation). If you have nausea or you are vomiting after surgery, you will receive additional standard of care drugs for those symptoms.

Electrical Stimulation:

The electrical stimulation is applied through a small sticky pad that is connected to a machine called a neuromuscular blockade monitor (NMBN). NMBNs are routinely used by anesthesiologists to monitor drug levels in muscles during surgery.

The pad will be placed on your wrist after you receive anesthesia and removed at the end of surgery so you will not know what group you are in.

Study Procedures:

Both Groups:

* You will have blood (about 2 teaspoons) collected intravenously (through your IV) during surgery. This blood will be used for genetic testing that may explain why people respond differently to treatments for nausea and vomiting.
* You will complete a questionnaire about your pre-treatment expectations and your nausea every 15 minutes after you wake up after surgery until you leave the clinic. It should take about 2-3 minutes to complete the questionnaire each time.

Length of Study:

Your participation in this study will be over once you leave the clinic after surgery.

This is an investigational study. The NMBM monitor is commercially available and FDA approved for use by anesthesiologists to monitor drug levels in the muscles during surgery. Its use in this study to control nausea/vomiting is investigational.

Up to 176 participants will be enrolled in this study. All will be enrolled at MD Anderson.

Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)

Intraoperative Electrical Stimulation of the Acupoint P6 to Prevent Post-Operative Nausea and Vomiting in Women Undergoing Breast Cancer Surgery

If a participant fails to have complete control of nausea at any time during PACU stay, participant considered as having PONV. Researchers will use a 1-sided chi-squared test of proportions with Type I error of 0.1 to test for difference in PONV incidence.

Nausea assessed verbally on an eleven-point scale (0=no nausea to 10=worst nausea imaginable). Vomiting defined as the forceful expulsion of gastric contents from the mouth. Retching, i.e. an active attempt to vomit without expulsion of gastric contents, categorized as vomiting. Complete control defined as no nausea ≥3, vomiting, or use of anti-emetics during PACU stay.

Trial feasible if:

1. At least 20% of screened patients meet inclusion criteria,
2. 50% of patients who meet the inclusion criteria consent, and
3. 75% of patients within the acupuncture arm complete all procedures.

M.D. Anderson Cancer Center

Digestive System Diseases

Wounds and Injuries

Behaviors and Mental Disorders

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Hyperthermia

Fever

Esophageal Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Gastrointestinal Diseases

Stomach Cancer

Anti-Infective Agents

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Mitomycins

Mitomycin

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Participants receive heated Mitomycin, Cisplatin, and Paclitaxel as a liquid that is injected through 3 to 4 small incisions into the abdomen over about 1 hour.

10 mg by vein approximately 60 minutes before Paclitaxel.

50 mg by vein approximately 60 minutes before Paclitaxel.

20 mg by vein approximately 60 minutes before Paclitaxel.

Mitomycin C 30 mg in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.

Mitomycin C

Cisplatin 200 mg in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.

Starting dose of Paclitaxel is 20 mg/m2 in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.

Dose-escalation scheme of Paclitaxel is in increments of 5 mg/m2.

Brian D. Badgwell, MD

The goal of this clinical research study is to find the highest tolerable dose of paclitaxel that can be given as hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with gastric or gastroesophageal cancer. HIPEC is a system in which heated chemotherapy is delivered directly inside the abdomen during surgery. In this study, paclitaxel is being combined with mitomycin and cisplatin to see if this study drug combination can help to control the disease.

This is an investigational study. Mitomycin, cisplatin, and paclitaxel are FDA-approved and commercially available for the treatment of gastric and gastroesophageal cancer. It is investigational to give these drugs by HIPEC.

The study doctor can describe how the study drugs and HIPEC are designed to work.

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

Study Groups:

If participant is found to be eligible to take part in this study, participant will be assigned to a dose level of paclitaxel based on when participant joins this study. Up to 8 dose levels of paclitaxel will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of paclitaxel is found.

All participants will receive the same dose level of mitomycin and cisplatin.

HIPEC Treatment and Study Visits:

On the day of HIPEC treatment, participant will receive heated mitomycin, cisplatin, and paclitaxel as a liquid that is injected through 3 to 4 small incisions in participant's abdomen over about 1 hour. Heated mitomycin, cisplatin, and paclitaxel will be delivered through plastic tubing that is connected to a pump into the abdominal cavity. The pump pushes the heated drugs into the abdominal cavity and then pulls it out and recirculates the drugs. The skin of the abdominal cavity is temporarily closed during this procedure. A pump will be used to pump the heated drugs in and out of the abdominal cavity over 60 minutes while the surgeon gently presses on the abdominal wall so the drugs can reach all areas in the abdominal cavity. After 60 minutes, the drugs are removed and the abdominal cavity will be washed. The remaining fluid will be removed before the surgeon closes the abdominal cavity with stitches.

Additionally, participant will be given standard drugs to help decrease the risk of side effects. Participant may ask the study staff for information about how the drugs are given and their risks.

Participant will remain in the hospital for 3-7 days after treatment.

While participant is in the hospital after surgery, blood (about 2-3 tablespoons) may be drawn for routine tests at any time that the study doctor thinks it is needed.

One (1) time between 2-6 weeks after HIPEC Treatment:

* Participant will have a physical exam.
* Blood (about 2-3 tablespoons) will be drawn for routine tests.

Follow-Up Visits:

Participant will have routine clinic visits or participant will be called every 6 months after the HIPEC procedure. Participant will be asked about any other cancer treatments participant may be receiving. If participant is called, these calls should last about 5-10 minutes. If participant stopped the study early, the study doctor may ask participant to return to the clinic for extra CT scans, PET scan, or MRIs during the follow-up period.

Participant will have a CT scan, PET scan, or MRI of participant's chest, abdomen, and pelvis every 6 months for 5 years after surgery to check the status of the disease.

Length of Study Participation:

Participant will be on study for about 5 years after participant's last procedure (HIPEC or surgery). Participant will be taken off study early if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.

Participation on the study will be over after the follow-up visits.

Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

A Phase I Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

MTD selected based on isotonic regression as specified per methods by Liu and Yuan.

Dose limiting toxicity (DLT) graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) by organ system. DLT defined as any grade III/IV non-hematologic or neutropenia-associated (infection or fever treated in the hospital) toxicity attributable to this therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)	NCT02473042	Post-Operative ... Breast Cancer	Electrical Stim... Zofran Dexamethasone Phenergan Pepcid Questionnaire	18 Years -	M.D. Anderson Cancer Center
Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology	NCT03330028	Diseases of Oes...	Dexamethasone Diphenhydramine Famotidine Mitomycin C Cisplatin Paclitaxel	18 Years -	M.D. Anderson Cancer Center
Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)	NCT02473042	Post-Operative ... Breast Cancer	Electrical Stim... Zofran Dexamethasone Phenergan Pepcid Questionnaire	18 Years -	M.D. Anderson Cancer Center
Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology	NCT03330028	Diseases of Oes...	Dexamethasone Diphenhydramine Famotidine Mitomycin C Cisplatin Paclitaxel	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for pepcid

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

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