Trial Outcomes & Findings for Low-Dose Ibuprofen in Improving Cognitive Impairment in Patients With Cancer (NCT NCT03186638)

Last Updated: 2023-09-25

Results Overview

Will be assessed by the Functional Assessment of Cancer Therapy-Cognitive Function. Means, standard deviations, and 95% confidence intervals will be determined in order to estimate preliminary population variances and effect sizes. These statistical measures will be calculated by group for the Pre(Baseline) and Post(6 Weeks) measures of the Functional Assessment of Cancer Therapy-Cognitive Function scores as well as the change (post-pre) in the scores using the subjects that completed the study (complete case estimation). The complete case estimates will be compared to multiple imputation estimates based on all subjects that completed pre-intervention. An analysis of covariance will be run using Functional Assessment of Cancer Therapy-Cognitive Function post-intervention as the response. Higher scores indicate better function; range is 0 to 148.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

87 participants

Primary outcome timeframe

Up to 41 days post-intervention

Results posted on

2023-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Ibuprofen) Patients receive ibuprofen PO BID for 6 weeks. Ibuprofen: Given PO Questionnaire Administration: Ancillary studies	Arm II (Placebo) Patients receive placebo PO BID for 6 weeks. Placebo: Given PO Questionnaire Administration: Ancillary studies
Overall Study STARTED	45	42
Overall Study Received Intervention and Completed Baseline Assessments	44	40
Overall Study COMPLETED	37	36
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Ibuprofen) Patients receive ibuprofen PO BID for 6 weeks. Ibuprofen: Given PO Questionnaire Administration: Ancillary studies	Arm II (Placebo) Patients receive placebo PO BID for 6 weeks. Placebo: Given PO Questionnaire Administration: Ancillary studies
Overall Study Withdrawal by Subject	4	4
Overall Study Withdrawn due to medical problem	3	2
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Low-Dose Ibuprofen in Improving Cognitive Impairment in Patients With Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ibuprofen 200mg BID n=45 Participants 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	Placebo n=42 Participants 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. Placebo: 200mg BID and 8 hours apart	Total n=87 Participants Total of all reporting groups
Age, Continuous	55.3 Years STANDARD_DEVIATION 12.5 • n=5 Participants	54.6 Years STANDARD_DEVIATION 12.8 • n=7 Participants	55 Years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants	38 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Cancer Type Breast	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Cancer Type Colorectal	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Cancer Type Other	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Cancer Type Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Education Level Some High School or Less	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Education Level Highschool/GED	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Education Level Less than 4 Year Degree	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Education Level 4 Year Degree	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Education Level Graduate Degree	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Education Level Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Cancer Stage Stage 1	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Cancer Stage Stage 2	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Cancer Stage Stage 3	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Cancer Stage Stage 4	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Cancer Stage Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Chemotherapy Actively Receiving	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Chemotherapy Not Actively Receiving	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Chemotherapy Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 41 days post-intervention

Population: 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=36 for Placebo (3-withdrawal by subject, 1- withdrawal due to medical issue) ; n=37 for Ibuprofen (3-withdrawal by subject, 3 - withdrawal due to medical issue, 1-lost to follow-up\*)

Outcome measures

Outcome measures
Measure	Ibuprofen 200 mg BID n=44 Participants 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	Placebo n=40 Participants 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. Placebo: 200mg BID and 8 hours apart
Effects of Ibuprofen on Alleviating Chemotherapy-related Cognitive Impairment Baseline (Pre)	89.98 score on a scale Standard Deviation 27.82	91.08 score on a scale Standard Deviation 25.98
Effects of Ibuprofen on Alleviating Chemotherapy-related Cognitive Impairment 6 Weeks (Post)	105.54 score on a scale Standard Deviation 25.44	107.75 score on a scale Standard Deviation 24.83
Effects of Ibuprofen on Alleviating Chemotherapy-related Cognitive Impairment Change from Baseline(Post - Pre)	14.59 score on a scale Standard Deviation 22.02	15.52 score on a scale Standard Deviation 21.43

Adverse Events

Ibuprofen 200 mg BID

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ibuprofen 200 mg BID n=45 participants at risk 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	Placebo n=42 participants at risk 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. Placebo: 200mg BID and 8 hours apart
Gastrointestinal disorders Diarrhea	2.2% 1/45 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.	0.00% 0/42 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.
Gastrointestinal disorders Enterocolitis infectious	0.00% 0/45 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.	2.4% 1/42 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.
Infections and infestations Enterocolitis infectious	2.2% 1/45 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.	0.00% 0/42 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.
Investigations Creatinine increased	2.2% 1/45 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.	0.00% 0/42 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.
Renal and urinary disorders Creatinine increased	0.00% 0/45 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.	2.4% 1/42 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.
Renal and urinary disorders Cystitis noninfective	0.00% 0/45 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.	2.4% 1/42 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.2% 1/45 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.	0.00% 0/42 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.2% 1/45 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.	0.00% 0/42 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.
Vascular disorders Arterial thromboembolism	0.00% 0/45 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.	2.4% 1/42 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.
Vascular disorders Hypotension	0.00% 0/45 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.	2.4% 1/42 • Number of events 1 • Adverse events were collected during the study intervention period. Approximately 6 weeks 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.

Other adverse events

Additional Information

Michelle Janelsins, PhD, MPH

University of Rochester Medical Center, Dept of Surgery, Supportive Care in Cancer

Phone: 585-276-4656

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place