An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical

Status Withdrawn

Clinical Trial Summary

This clinical trial studies how well an exercise intervention works in reducing symptoms and improving clinical outcomes in patients with ovarian cancer undergoing platinum-based chemotherapy. Exercise may "train" the body to repair deoxyribonucleic acid (DNA) damage more efficiently, which may reduce symptoms related to platinum-based chemotherapy, improve quality of life, increase survival, and decrease recurrence rates in patients with ovarian cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the feasibility of recruiting and enrolling newly diagnosed epithelial ovarian cancer patients who have undergone debulking surgery and will be starting platinum-based chemotherapy, to an exercise trial.

II. To evaluate adherence to the data collection and exercise trial protocol. It is necessary to determine the feasibility of collecting tablet-based questionnaire data and blood samples at multiple time points in one visit. It is also critical to determine whether the exercise intervention is feasible in this patient population.

SECONDARY OBJECTIVES:

I. To examine changes in DNA repair function before and after a single exercise session.

II. To examine changes in DNA repair function, body composition, quality of life, symptoms and patient satisfaction with care over the treatment time course.

III. To examine the effect of the exercise intervention on these measurements.

IV. To follow the patients an additional 12-months for clinical outcomes defined as death, cancer recurrence, or new primary cancer.

OUTLINE: Patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day 1.Treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive a home-based exercise prescription including instructions for keeping patients' heart rate within 50-80% maximum.

After completion of study, patients are followed up for 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02878980
Study type	Interventional
Source	City of Hope Medical Center
Contact
Status	Withdrawn
Phase	N/A
Start date	September 2, 2016
Completion date	December 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05494580` - Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer	Phase 1/Phase 2
Withdrawn	`NCT02530606` - Photoacoustic Imaging in Detecting Ovarian or Fallopian Tube Cancer	N/A
Active, not recruiting	`NCT02244502` - Safety, Feasibility and Effect of TTFields (200 kHz) Concomitant With Weekly Paclitaxel in Recurrent Ovarian Carcinoma (INNOVATE)	Phase 1/Phase 2
Terminated	`NCT02218502` - Study Into a New Diagnostic Tool (Simple Ultrasound-based Rules) in Patients With Adnexal Masses	N/A
Terminated	`NCT01936974` - (PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma	Phase 2
Recruiting	`NCT02073500` - Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
Completed	`NCT00756847` - Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors	Phase 1
Active, not recruiting	`NCT02194387` - Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members	N/A
Recruiting	`NCT05001282` - A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)	Phase 1/Phase 2
Recruiting	`NCT04981119` - Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Completed	`NCT00989651` - Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer	Phase 1
Not yet recruiting	`NCT05591560` - Itraconazole in Advanced Ovarian Cancer	N/A
Completed	`NCT01481701` - A Trial Evaluating Efficacy and Safety of Oxaliplatin With 5-Fluorouracil in Patients With Recurrent Ovarian Carcinoma	Phase 2
Completed	`NCT00181701` - Intraperitoneal Paclitaxel and Carboplatin in the Treatment of Women With Carcinoma of Mullerian Origin	Phase 2
Terminated	`NCT00047632` - Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer	Phase 3
Recruiting	`NCT03302884` - Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma	N/A
Completed	`NCT02166905` - DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission	Phase 1/Phase 2
Recruiting	`NCT04851119` - Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors	Phase 1/Phase 2
Recruiting	`NCT03296826` - Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2
Recruiting	`NCT04147494` - Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues	Early Phase 1

An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical Outcomes of Platinum-Based Treatment in Ovarian Cancer Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms