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| ID | Type | Description | Link |
|---|---|---|---|
| K07CA168886 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Placebo | Placebo Comparator | 200mg placebo (taken twice a day at least 8 hours apart) for a period of 6 weeks. |
|
| Ibuprofen 200 mg BID | Active Comparator | 200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | 200 mg BID and 8 hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle C Janelsins, Ph.D. | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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) | Posted | Mean | Standard Deviation | % correct | Baseline and 6 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection - Urinary Tract | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle C. Janelsins, PhD, MPH | University of Rochester Medical Center | (585) 276-4656 | Michelle_Janelsins@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2018 | Dec 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D015444 | Exercise |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Home-Based Exercise | Behavioral | A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period |
|
|
| Placebo | Drug | 200mg BID and 8 hours apart |
|
|
| Lost to Follow-up |
|
| Withdrawn due to Medical Problem |
|
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Cancer Type | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Cancer Stage | 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. | Count of Participants | Participants |
|
| OG001 | 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 |
| OG002 | 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 |
| OG003 | 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 |
|
|
|
| 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 | 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) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
|
| 0 |
| 25 |
| 3 |
| 25 |
| 2 |
| 25 |
| EG001 | 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 | 0 | 23 | 0 | 23 | 6 | 23 |
| EG002 | 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 | 0 | 25 | 0 | 25 | 10 | 25 |
| EG003 | 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 | 0 | 24 | 1 | 24 | 3 | 24 |
| Gastrointestinal disorders - Melena | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Abdominal Pain | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Otitis Media | Eye disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Puritis | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Edema | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Atrial Thrombus | Cardiac disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Abdominal Pain | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Chills | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Neoplasm benign - Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Sore Throat | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Retinopathy | Eye disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Pain - Postoperative | Surgical and medical procedures | CTCAE (Unspecified) | Non-systematic Assessment |
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| Ear Pain | Ear and labyrinth disorders | CTCAE (Unspecified) | Non-systematic Assessment |
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| Nausea | General disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
| Creatinine increased | Renal and urinary disorders | CTCAE (Unspecified) | Non-systematic Assessment |
|
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| D018712 |
| Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D002241 | Carbohydrates |
| Title | Measurements |
|---|---|
|
|
| 6 Weeks |
|
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