Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Ibuprofen

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.

200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.

200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks.

200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.

A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period

Home-Based Exercise

Placebo

Michelle C Janelsins, Ph.D.

This research seeks to determine if a combination of low-dose ibuprofen along with a structured home-based walking and progressive resistance exercise program, EXCAP, will be effective in reducing cognitive difficulties among cancer patients receiving chemotherapy.

To conduct a feasibility pilot to assess preliminary efficacy of a 6 week course of ibuprofen (200 mg BID with does 8 hours apart) and a structured home based walking/progressive resistance program, EXCAP, alone or together, on cognitive function and levels of inflammatory molecules among cancer patients receiving chemotherapy (beginning at cycle 2). If these interventions prove to be useful and have potential benefit, they could have a substantial impact on treating cognitive difficulties experienced by cancer patients as well as improve quality of life. Moreover, if there is an effect of these interventions on cognitive functioning and inflammation, we will gain more knowledge of a possible mechanism of chemotherapy-related cognitive difficulties.

The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients

A Phase II Study of the Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients Undergoing Chemotherapy

Overall study results will be presented to participants, faculty and staff at the University of Rochester Medical Center. tudy results will be presented at professional meetings and published

Memory performances (percent correct across delays) as assessed by the objective CANTAB delayed matching to sample task Percentage correct range (0 to 100) Higher percentage is better

Cognitive functioning score as assessed subjectively by a psychometrically validated instrument (FACT-COG) - Perceived Cognitive Impairment (PCI) (min=0, max=116) Higher Score is better

National Institutes of Health (NIH)

National Cancer Institute (NCI)

University of Rochester

Associate Professor

Adverse event definition does not differ from clinicaltrials.gov definition. A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or is an important medical event.

200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.

Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period

Placebo: 200mg BID and 8 hours apart

Placebo and Home-Based Exercise

200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks.

Placebo: 200mg BID and 8 hours apart

200mg ibuprofen (taken twice a day at least 8 hours apart) and a progressive walking and resistance band exercise program called Exercise for Cancer Patient (EXCAP) for a period of 6 weeks.

Ibuprofen: 200 mg BID and 8 hours apart

Home-Based Exercise: A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period

Ibuprofen 200mg BID, Home-Based Exercise

200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.

Ibuprofen: 200 mg BID and 8 hours apart

Ibuprofen 200 mg BID

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Cancer Type

Education Level

Stage 1.This stage is usually a small cancer or tumor that has not grown deeply into nearby tissues. It also has not spread to the lymph nodes or other parts of the body.

Stage 2 and 3.These stages indicate larger cancers or tumors that have grown more deeply into nearby tissue. They may have also spread to lymph nodes but not other parts of the body.

Stage 4.This stage means that the cancer has spread to other organs or parts of the body. It may also be called metastatic cancer.

Stage 1 is best, Stage 4 is worst.

Cancer Stage

Michelle C. Janelsins, PhD, MPH

Basline

6 Weeks

Note: Whenever the 6-week number of subject is less than the baseline number of subject this is due to the data not being available. n=17 for Placebo and Home-Based Exercise (1-withdrawal by subject, 1-lost to followup, 2-withdrawal due to medical reason); n=22 for Placebo Only; n=21 for Ibuprofen and Home-Based Exercise (1-withdrawal due to medical reason ); n=18 for Ibuprofen Only (2-withdrawal due to subject, 1=lost to followup)

Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm

Baseline

Note: Whenever the 6-week number of subjects or baseline number of subjects is less than the number reported per arm this is due to the data not being available. n=17 for Placebo and Home-Based Exercise (1-withdrawal by subject, 1-lost to followup, 2-withdrawal due to medical reason); n=22 for Placebo Only; n=20 for Ibuprofen and Home-Based Exercise (1-withdrawal due to medical reason, 1-unknown ); n=18 for Ibuprofen Only (2-withdrawal due to subject, 1=lost to followup)

Spots Global Cancer Trial Database for cognitive difficulties