Symptoms and General Pathology

All Conditions

Fatigue

Asthenia

This arm will begin the Walk With Ease program after the completion of chemotherapy.

The arm will begin the Walk With Ease program three months after completion of chemotherapy.

Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention is a self-directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes a day, five days a week.

Walk With Ease

Hyman B Muss, MD

This study will look at the impact of a self-directed walking program on post-chemotherapy survivors experiencing fatigue. It is hypothesized that the walking program will help lessen fatigue.

The investiagors propose to evaluate the impact of a home-based self-directed walking program on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- Senior Physical Activity after Chemotherapy (S-PACT). Participants must have potentially curable cancer, moderate to severe fatigue (score of 4 or higher on the Brief Fatigue Inventory), currently exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation treatment must also be completed if it is part of the patient's treatment plan) within the last 6 weeks. The design is a randomized controlled trial, with participants randomized to a 3-month physical activity program (intervention group) or to wait-list control (this group begins the walking program at 3 months post-randomization). The primary objective is to compare the change in fatigue scores from baseline to 3 months between the intervention and wait-list control groups.

The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older

A Randomized, Wait-list Controlled Clinical Trial: the Effect of a Physical Activity Program on Fatigue After Potentially Curative Chemotherapy Among Cancer Survivors Age 65 or Older -- PACT (Physical Activity After Chemotherapy)

Change in fatigue will be measured using the FACIT-F.

This outcome will be measured by the Brief Fatigue Inventory

To characterize the safety of the walking program through a review of the number and type of adverse events, including falls, reported by study participants to the Study Team.

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Engagement in walking (total minutes per week) as measured by engagement in physical activity questions

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Physical function as measured by SPPB

To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.

Quality of life as measured by FACT-G (global and subscales) and symptom scales, including PROMIS pain intensity, sleep disturbance and depression.

Breast Cancer Research Foundation

UNC Lineberger Comprehensive Cancer Center

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Lipid Regulating Agents

Docetaxel

Lovastatin

L 647318

Dihydromevinolin

Tubulin Modulators

Antimitotic Agents

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.

Susan Roman, DO

This purpose of this study is to evaluate the use of two medications, docetaxel and lovastatin to determine the highest dose of lovastatin and docetaxel that can be given safely as well as the safety of combining the two drugs and the effect on the subject's tumor. Subjects can have any cancer.

The primary objective of this study is to determine the maximum tolerated dose (MTD) of lovastatin and docetaxel in patients with various different cancers.

A Study of the Proper Dosage of Lovastatin and Docetaxel for Patients With Cancer

To determine the maximum tolerated doses (MTD) of lovastatin and docetaxel in patients with various cancers having solid tumors.

Susan L Roeder

Physician

Determine the maximum tolerated dose (MTD) of escalating doses of lovastatin in combination with docetaxel in patients with any type of solid tumor.

Lovastatin and Docetaxel: Docetaxel (60 mg/m2) will be given on day 0 every three weeks with incrementally increasing doses of lovastatin. Lovastatin will be administered p.o. following a four times a day schedule, for four consecutive days (days -1 to +2) and repeated every three weeks. For purposes of this study, intermittent drug administration, six dose levels, ranging from 2 to 24 mg/kg/day (2, 4, 7, 10, 13, 18, and 24 mg) will be used. Once the maximum tolerated dose (MTD) of lovastatin has been determined, docetaxel will be escalated in a stepwise scheme from 60 to 80 to 100 mg/m2.

Dose Esclation

Study was terminated prior to completion.

Age, Categorical

Study terminated prior to completion. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Study terminated due to funding issues prior to completion. No data were analyzed. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.

Cena Jones-Bitterman

Study terminated prior to completion. Data not collected. Enrollment was halted prematurely and will not resume. Participants are no longer being examined or treated.

Incidence of Dose-limiting Toxicities (DLTs)

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Pulmonary Embolism

Embolism

Thrombosis

Embolism and Thrombosis

Vascular Diseases

Lung Diseases

Respiratory Tract Diseases

Coagulants

Fibrin fragment D

Antifibrinolytic Agents

Hemostatics

Patients to have a CT pulmonary angiogram for suspected pulmonary embolism will have a d-dimer drawn as is routinely done.

A CT pulmonary angiogram and a d-dimer drawn within 24 hours.

CT pulmonary angiogram and d-dimer draw

The purpose of this study is to see if a blood test (D-dimer) is as precise as the CT scan for the detection of clots.

A pulmonary embolism is an obstruction of the blood vessels in your lungs usually due to a blood clot that travels to the lungs usually from the leg. Research has shown that the results of a specific blood test (D-dimer) can be used instead of a CT scan to diagnose clots. D-dimer is a valuable diagnostic marker in either detecting the presence of or monitoring the progress of blood clots. D-dimer assays have proven to be a beneficial diagnostic tool in the evaluation of patients with suspected pulmonary embolism (PE).

Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population

Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population: A Correlation With Ct Pulmonary Angiogram in the Urgent Care Setting

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older	NCT02191982	Cancer Geriatric Fatigue	Walk With Ease	65 Years -	UNC Lineberger Comprehensive Cancer Center
A Study of the Proper Dosage of Lovastatin and Docetaxel for Patients With Cancer	NCT00584012	Any Cancer Breast Cancer	Lovastatin Docetaxel	19 Years - 90 Years	University of Iowa
Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population	NCT00615147	Cancer Pulmonary Embol...	CT pulmonary an...	21 Years -	Memorial Sloan Kettering Cancer Center
Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population	NCT00615147	Cancer Pulmonary Embol...	CT pulmonary an...	21 Years -	Memorial Sloan Kettering Cancer Center

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Every month we try and update this database with for any cancer 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 any cancer

Every month we try and update this database with for any cancer 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 any cancer 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.