Cancer-related Cognitive Difficulties
Conditions
Keywords
Cancer, Cognitive difficulties
Brief 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.
Interventions
DRUGIbuprofen
200 mg BID and 8 hours apart
BEHAVIORALHome-Based Exercise
A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period
DRUGPlacebo
200mg BID and 8 hours apart
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must report cognitive difficulties of 3 or higher on a 0-10 scale * Must provide informed consent * Be able to read English * Have a primary diagnosis of cancer * Be able to swallow medication * Women of child-bearing potential must not be pregnant or become pregnant during the 6 week study * Agree not to take NSAIDs during the 6 week intervention period * Be scheduled to receive at least 2 additional cycles of oral or IV chemotherapy over the 42-day study period. * Must have the approval of their treating physician to begin the exercise program and receive the ibuprofen * Must be over 18 years of age
Exclusion criteria
* Currently taking a consistent dosage of a NSAID at least 3 days a week for the last 3 months that is over 400mg daily * Have an allergy to ibuprofen * Be identified as in active or maintenance stage of exercise behavior as assessed by the single-item exercise stages of change short form * have physical limitations that contraindicate participation in sub-maximal physiological fitness testing or a low to moderate home-based walking and progressive resistance program * have a history of peptic ulcer disease within the last 12 months * Diagnosed with a neurodegenerative disease * Had a myocardial infraction within the past 6 months * Patients with a neutropenic episode during the first cycle of chemotherapy or at high risk for a neutropenic episode during future chemotherapy cycles at the treating physicians discretion * Have confirmed metastatic disease to the central nervous system * Have been hospitalized for a major psychiatric illness within the last 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm | Baseline and 6 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm | Baseline and 6 weeks | 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 |
Countries
United States
Participant flow
Pre-assignment details
110 subjects were consented. Of those 110 subjects, 97 were randomized, 13 excluded. Of the 13 excluded, 7 were by the subject's request, 5 had a medical problem which rendered them ineligible, and 1 was a screening failure. Of the 97 subjects randomized, 11 participants were excluded. Of the 11 excluded, 9 were by the subject's request and 2 were lost to follow up. 86 participants received the intervention and completed baseline assessments (Overall Study Table Below).
Participants by arm
| Arm | Count |
|---|---|
| Placebo and Home-Based Exercise 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 | 25 |
| Placebo 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks.
Placebo: 200mg BID and 8 hours apart | 23 |
| Ibuprofen 200mg BID, Home-Based Exercise 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 | 25 |
| Ibuprofen 200 mg BID 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 | 24 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 1 | 2 | 5 |
| Overall Study | Withdrawn due to Medical Problem | 2 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo and Home-Based Exercise | Placebo | Ibuprofen 200mg BID, Home-Based Exercise | Ibuprofen 200 mg BID | Total |
|---|---|---|---|---|---|
| Age, Continuous | 54.19 years STANDARD_DEVIATION 10.52 | 54.95 years STANDARD_DEVIATION 12.51 | 54.86 years STANDARD_DEVIATION 11.86 | 50.29 years STANDARD_DEVIATION 8.92 | 53.60 years STANDARD_DEVIATION 11.04 |
| Cancer Stage Stage 1 | 2 Participants | 4 Participants | 5 Participants | 2 Participants | 13 Participants |
| Cancer Stage Stage 2 | 11 Participants | 7 Participants | 6 Participants | 9 Participants | 33 Participants |
| Cancer Stage Stage 3 | 4 Participants | 6 Participants | 11 Participants | 5 Participants | 26 Participants |
| Cancer Stage Stage 4 | 8 Participants | 6 Participants | 3 Participants | 8 Participants | 25 Participants |
| Cancer Type Breast | 19 Participants | 19 Participants | 17 Participants | 18 Participants | 73 Participants |
| Cancer Type Gastrointestinal | 4 Participants | 4 Participants | 7 Participants | 5 Participants | 20 Participants |
| Cancer Type Other | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Education Level 2 to 4 Year Degree | 13 Participants | 10 Participants | 11 Participants | 15 Participants | 49 Participants |
| Education Level Graduate Degree | 3 Participants | 8 Participants | 9 Participants | 4 Participants | 24 Participants |
| Education Level Highschool/GED or less | 4 Participants | 4 Participants | 1 Participants | 2 Participants | 11 Participants |
| Education Level Unknown | 5 Participants | 1 Participants | 4 Participants | 3 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 23 Participants | 24 Participants | 23 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 1 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 22 Participants | 24 Participants | 23 Participants | 89 Participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 22 Participants | 21 Participants | 87 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 3 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 23 | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 2 / 25 | 6 / 23 | 10 / 25 | 3 / 24 |
| serious Total, serious adverse events | 3 / 25 | 0 / 23 | 0 / 25 | 1 / 24 |
Outcome results
Primary
Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm
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
Time frame: Baseline and 6 weeks
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo and Home-Based Exercise | Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm | Basline | 75.2 % correct | Standard Deviation 19.9 |
| Placebo and Home-Based Exercise | Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm | 6 Weeks | 89.4 % correct | Standard Deviation 10.3 |
| Placebo | Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm | 6 Weeks | 90.0 % correct | Standard Deviation 10.2 |
| Placebo | Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm | Basline | 82.7 % correct | Standard Deviation 17.8 |
| Ibuprofen 200mg BID, Home-Based Exercise | Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm | Basline | 83.6 % correct | Standard Deviation 19.2 |
| Ibuprofen 200mg BID, Home-Based Exercise | Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm | 6 Weeks | 87.6 % correct | Standard Deviation 16.1 |
| Ibuprofen 200 mg BID | Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm | Basline | 74.3 % correct | Standard Deviation 20.1 |
| Ibuprofen 200 mg BID | Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm | 6 Weeks | 90.0 % correct | Standard Deviation 15.7 |
p-value: 0.9168ANCOVA
Secondary
Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm
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
Time frame: Baseline and 6 weeks
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo and Home-Based Exercise | Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm | Baseline | 74.7 score on a scale | Standard Deviation 22 |
| Placebo and Home-Based Exercise | Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm | 6 Weeks | 80.5 score on a scale | Standard Deviation 19.7 |
| Placebo | Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm | 6 Weeks | 76.5 score on a scale | Standard Deviation 20.2 |
| Placebo | Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm | Baseline | 72.7 score on a scale | Standard Deviation 18.1 |
| Ibuprofen 200mg BID, Home-Based Exercise | Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm | Baseline | 85.9 score on a scale | Standard Deviation 17.1 |
| Ibuprofen 200mg BID, Home-Based Exercise | Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm | 6 Weeks | 88.0 score on a scale | Standard Deviation 21 |
| Ibuprofen 200 mg BID | Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm | Baseline | 76.2 score on a scale | Standard Deviation 18.9 |
| Ibuprofen 200 mg BID | Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm | 6 Weeks | 78.9 score on a scale | Standard Deviation 21.8 |
p-value: 0.6536ANCOVA