NCT01238120

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cancer-related Cognitive Difficulties

Interventions

Type	Name	Description
DRUG	Ibuprofen	200 mg BID and 8 hours apart
BEHAVIORAL	Home-Based Exercise	A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period
DRUG	Placebo	200mg BID and 8 hours apart

Timeline

• Start date: 2010-11-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2010-11-10
• Last updated: 2021-05-05
• Results posted: 2021-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study