Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Propranolol

Etodolac

Adrenergic beta-Antagonists

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively. Postoperative Psychological Interventions may occur between POD 1-7 if needed.

Participants will receive usual care (study interventions not specifically recommended)

MBRT is a meditation technique used to achieve relaxation)

Mind-body resilience training

Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements

Music therapy

Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16)

Etodolac 400 mg PO BID (for 21 consecutive days)

Kara Long Roche, MD

Anoushka Afonso, MD

The purpose of this study is to see if propranolol and etodolac along with mind-body resilience training/MBRT and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery/PDS or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).

A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)

Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The primary objective of this study is to investigate the feasibility of implementing a multimodal PSRB in women undergoing PDS or IDS for advanced EOC. This will be measured as number of patients successfully completing over 80% of the bundled interventions, including a preoperative integrative medicine session, postoperative integrative medicine session, total intravenous anesthesia on day of surgery, and perioperative beta blocker and COX2 inhibitor

Memorial Sloan Kettering Cancer Center

Symptoms and General Pathology

Wounds and Injuries

Behaviors and Mental Disorders

Hyperthermia

Fever

Quality of Life

Antineoplastic Agents

Central Nervous System Depressants

Other Dietary Supplements

Carboplatin

Benzocaine

Tannic Acid

Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.

Performed less than 12 weeks after intravenous chemotherapy cycles are completed.

Second look laparoscopy reassessment surgery (SLLRS)

Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes.

Patients who exhibit the following will not receive the HIPEC procedure:

* Extraperitoneal disease noted at the time of the second look procedure
* Macroscopic intraperitoneal disease which is not resectable to R1
* Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion
* Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC

Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research.

HIPEC with Carboplatin

Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.

FACT-O Quality of Life Questionnaire

Study Nurse

Laurel Berry, MD

The purpose of this research study is to see if it is feasible to receive heated chemotherapy or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on participants' health.

Primary Objective: Determine the feasibility of second look laparoscopy and hyperthermic intraperitoneal chemotherapy with carboplatin.

Secondary Objective(s)

* To compare the quality if life in patients with ovarian cancer after undergoing second look laparoscopic reassessment surgery with hyperthermic intraperitoneal chemotherapy using carboplatin (CBDCA) versus quality of life in patients treated with cytoreduction surgery and systemic chemotherapy alone.
* To describe toxicities in patients with ovarian cancer treated with second look laparoscopy and simultaneous hyperthermic intraperitoneal chemotherapy.

OUTLINE:

Patients undergo second look laparoscopy. Patients with visible signs of cancer in abdomen also receive HIPEC with carboplatin via intraperitoneal injection (IP) over 90 minutes in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 6 months.

Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy

A Phase II Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With HIPEC in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

The proportion of feasibility is defined as the number of patients who successfully undergo SLL and HIPEC divided by the number of patients who are eligible and consent to participate. The feasibility proportion and its 95% confidence interval will be estimated.

The quality of life in patients with advanced ovarian cancer after undergoing second look laparoscopy reassessment surgery with hyperthermic intraperitoneal chemotherapy using Carboplatin (CBDCA) will be determined by the FACT-O questionnaire at pre-study, and months 3, and 6 in follow-up (post-treatment). The distribution of quality of life at each visit and the distribution of change in quality of life at each follow-up visit will be examined and the descriptive statistics will be presented. Scoring scale - (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = very much) and includes questions relating to Physical Well-Being (7 items), Social Well-being (7 items), Functional Well-Being (7 items), Emotional Well-Being (6 items) and Additional Ovarian Cancer Concerns (12-item). Scores could range from 0-156. Higher scores are associated with better QOL.

Toxicities will be indicated by the number and severity of adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. . Counts and percentages will be calculated for each adverse event. Mean, standard deviation, median, and interquartile range will be calculated for number of adverse events.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)	NCT05429970	Ovarian Cancer Ovarian Carcino... Stage II Ovary ... Stage II Ovaria... Stage III Ovary... Stage III Ovari... Stage IV Ovary ... Stage IV Ovaria... Epithelial Ovar... Fallopian Tube ... Stage II Fallop... Stage III Fallo... Stage IV Fallop... Primary Periton...	Mind-body resil... Music therapy Propranolol Etodolac	18 Years -	Memorial Sloan Kettering Cancer Center
Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy	NCT04415944	Ovarian Epithel... Ovarian Epithel... Ovarian Epithel... Stage I Fallopi... Stage II Fallop... Stage III Fallo... Peritoneal Carc...	Second look lap... HIPEC with Carb... FACT-O Quality ...	18 Years -	Wake Forest University Health Sciences
Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy	NCT04415944	Ovarian Epithel... Ovarian Epithel... Ovarian Epithel... Stage I Fallopi... Stage II Fallop... Stage III Fallo... Peritoneal Carc...	Second look lap... HIPEC with Carb... FACT-O Quality ...	18 Years -	Wake Forest University Health Sciences
A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)	NCT05429970	Ovarian Cancer Ovarian Carcino... Stage II Ovary ... Stage II Ovaria... Stage III Ovary... Stage III Ovari... Stage IV Ovary ... Stage IV Ovaria... Epithelial Ovar... Fallopian Tube ... Stage II Fallop... Stage III Fallo... Stage IV Fallop... Primary Periton...	Mind-body resil... Music therapy Propranolol Etodolac	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for stage ii fallopian tube cancer