Cancer-related Cognitive DifficultiesPhase 2NCT01238120
The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients
A Phase 2 study testing Ibuprofen and Home-Based Exercise in people with Cancer-related Cognitive Difficulties, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-related Cognitive Difficulties
- What is being tested?
- Ibuprofen and Home-Based Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of the Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients Undergoing Chemotherapy
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.
Read the 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
- Being tested
- Ibuprofen, Home-Based Exercise, Placebo
- Keywords
- Cancer, Cognitive difficulties
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called nonsteroidal anti-inflammatory drug
200 mg BID and 8 hours apart
Home-Based ExerciseBehavioural
Also called Exercise for Cancer Patients
A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period
PlaceboDrug
Also called Sugar Pill
200mg BID and 8 hours apart
| Study group | Role | What they receive |
|---|---|---|
| Placebo and Home-Based Exercise | Active comparator | 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. Receives: Behavioral: Home-Based Exercise; Drug: Placebo |
| Ibuprofen 200mg BID, Home-Based Exercise | Active comparator | 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. Receives: Drug: Ibuprofen; Behavioral: Home-Based Exercise |
| Placebo | Placebo comparator | 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. Receives: Drug: Placebo |
| Ibuprofen 200 mg BID | Active comparator | 200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 6 weeks
Secondary outcomes (1)
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
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer-related Cognitive DifficultiesStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michelle Janelsins, PhD, MPH, University of Rochester
- Investigators
- Michelle C Janelsins, Ph.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238120
- Sponsor's protocol ID
- 31416
- Other IDs
- K07CA168886
- Status last verified
- Apr 2021
- First submitted
- 9 Nov 2010
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT01238120
- Acronym / sponsor ID
- 31416
- Conditions
- Cancer-related Cognitive Difficulties
- Keywords
- Cancer, Cognitive difficulties
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Nov 2010
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 10 Nov 2010 (estimated)
- Results
- Posted 17 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo and Home-Based Exercise | Active comparator | Behavioral: Home-Based Exercise, Drug: Placebo200mg 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. |
| Ibuprofen 200mg BID, Home-Based Exercise | Active comparator | Drug: Ibuprofen, Behavioral: Home-Based Exercise200mg 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. |
| Placebo | Placebo comparator | Drug: Placebo200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. |
| Ibuprofen 200 mg BID | Active comparator | Drug: Ibuprofen200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: nonsteroidal anti-inflammatory drug200 mg BID and 8 hours apart | Drug | Ibuprofen 200 mg BID, Ibuprofen 200mg BID, Home-Based Exercise |
| Home-Based ExerciseAlso: Exercise for Cancer PatientsA progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period | Behavioural | Ibuprofen 200mg BID, Home-Based Exercise, Placebo and Home-Based Exercise |
| PlaceboAlso: Sugar Pill200mg BID and 8 hours apart | Drug | Placebo, Placebo and Home-Based Exercise |
Primary outcome
Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm
Time frame: 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
1 secondary outcome
Cognitive Functioning Score as Assessed by FACT-COG Questionnaire - Perceived Cognitive Impairment (PCI) - Mean Values by Arm
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle C Janelsins, Ph.D. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibuprofen and Home-Based Exercise in people with Cancer-related Cognitive Difficulties, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory Performance as Assessed by Computerized Cognitive Assessment - Mean Values by Arm (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.