Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Peritoneal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Abdominal Neoplasms

Peritoneal Diseases

Patients wear Fitbit Zip (portable pedometer device) to track physical activity for 7 days before undergoing surgery and for 21 more days after undergoing surgery.

Use pedometer to monitor physical activity

Management of Therapy Complications Fitbit Zip (portable pedometer device)

Questionnaire Administration

Quality-of-Life Assessment

Clancy Clark

This pilot clinical trial studies how well consumer-based activity monitor works in evaluating and measuring activity of older patients with abdominal cancer undergoing surgery. Consumer-based activity monitor (CAM) may identify patients who are at-risk for increased post-surgery medical problems. With early identification of at-risk patients, CAM provide supervised exercise in the preoperative and postoperative periods to improve over mobility and potentially decrease preoperative complications among patients undergoing major abdominal surgery.

PRIMARY OBJECTIVES:

I. To demonstrate the feasibility and adherence of using a consumer-based activity monitor during the preoperative period both in the hospital as well as at home.

SECONDARY OBJECTIVES:

I. To evaluate the ability of a consumer-based activity monitor to demonstrate a 50% decrease in average daily steps for participants before and after major oncologic surgery.

II. To characterize in-home movement among older cancer patients. III. To compare in-home CAM data to in-clinic pre- and post-operative mobility testing using the Short Physical Performance Battery (SPPB).

IV. To compare in-home CAM data to pre- and post-operative self-reported mobility using the Pepper Assessment Tool for Disability (PAT-D) and the Mobility Assessment Tool-Short Form (MAT-sf).

V. To compare in-home CAM data to self-reported daily activity data during the pre- and post-operative period.

VI. To determine estimates of future study accrual, adherence, and drop-out. VII. To obtain participant feedback from participants to determine potential study opportunities and barriers.

VIII. To identify potential key stakeholders and potential patient partners for development of future grant submissions.

IX. To summarize baseline cognitive screens, physical assessment questionnaire (Pepper Assessment Tool for Disability, PAT-D), mobility assessment tool-short form (MAT-sf), health-related quality of life (FACIT-G) questionnaire, activity questionnaire (Community Healthy Activities Model Program for Seniors \[CHAMPS\]), pain assessment (Pain Visual Analog Scale, PVAS), fatigue assessment (Fatigue Visual Analog Scale, FVAS), and physical function testing (Short Physical Performance Battery and time to complete 400-meter walk).

X. CAM data will be compared with research grade activity data provided by the ActiGraph.

OUTLINE:

Patients wear Fitbit Zip (portable pedometer device) to track physical activity for 7 days before undergoing surgery and for 21 more days after undergoing surgery.

After completion of study, patients are followed up at 21 and 90 days.

Consumer-Based Activity Monitor in Evaluating and Measuring Activity of Older Patients With Abdominal Cancer Undergoing Surgery

Pilot Study of a Consumer-Based Activity Monitor (Fitbit Zip) in Evaluating Perioperative Activity of Older Adults Undergoing Major Oncologic Surgery

Feasibility will be defined as the number of patients who self-report wearing the CAM device at least 16 days of the 21 day period.

This outcome measure will be the change in daily steps for participants before and after major oncologic surgery. Change in median (IQR) steps reported.

This outcome measure is to compare pre- and post-operative mobility using the Short Physical Performance Battery (SPPB). Median (IQR) change in SPPB from baseline to 90 days is reported.The scale range is 0-16. Higher scores denotes better outcomes.

This outcome measure is to compare pre- and post-operative mobility testing using the 400-meter walk. Median (IQR) change in 400 m walk from baseline to 90 days is reported. The duration it takes the participant to walk 400 meters will be recorded in seconds.

This outcome measure is to compare pre- and post-operative self-reported mobility using the Pepper Assessment Tool for Disability (PAT-D). Median (IQR) change in PAT-D is reported.

This outcome measure is to compare pre- and post-operative self-reported mobility using the Mobility Assessment Tool-Short Form (MAT-sf). Median (IQR) change in MAT-sf is reported. The score range is 30-80 and higher scores denotes better outcomes.

This outcome measure is to compare self-reported activity data (CHAMPS) during the pre- and post-operative period. Median (IQR) change in CHAMPS is reported. CHAMPS measures activity of the participant and how long they could do the activity. The score range is 0-108. Higher scores denotes better outcomes.

FACT-G is a 27-item compilation of general questions divided into 4 primary quality of life (QOL) domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The subscales are summed to produce a total score. The total score range is 0-108 and a higher score indicates better quality of life. Outcomes is to compare FACT-G at baseline and 90 days. Change in FACT-G is reported in median (IQR).

The pain VAS is a unidimensional measure of pain intensity providing a range of scores from 0-100. A higher score indicates greater pain intensity. Change in median (IQR) pain score from baseline to 90 days is reported.

The fatigue VAS is a unidimensional measure of fatigue providing a range of scores from 0-100. A higher score indicates greater fatigue. Change in median (IQR) fatigue score from baseline to 90 days is reported.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

No adverse events occurred for study. Definitions used for adverse events did not differ from clinicaltrials.gov

Patients wear Fitbit Zip (portable pedometer device) to track physical activity for 7 days before undergoing surgery and for 21 more days after undergoing surgery.

Management of Therapy Complications Fitbit Zip (portable pedometer device): Use pedometer to monitor physical activity

Questionnaire Administration: Ancillary studies

Quality-of-Life Assessment: Ancillary studies

Supportive Care (Consumer-based Activity Monitor)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

This feasibility study closed early due to slow accrual and inability to capture specific study variables. Small sample size limited study analysis and prevents reliable interpretation of data collected.

Dr. Clancy Clark

34 patients enrolled in study. 28 patients had data collected. Due to challenges associated with data collection, partial data was collected for 18 patients.

Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period

16 subjects had sufficient data for partial analysis.

Change in Daily Steps for Participants Before and After Major Oncologic Surgery

Only 9 subjects had SPPB measured at baseline and 90 days.

Change in Short Physical Performance Battery (SPPB)

Only 10 subjects had 400m walk measured at baseline and 90 days

Change in Duration of 400-meter Walk

Data were not collected and therefore analysis cannot performed.

Change in Pepper Assessment Tool for Disability (PAT-D)

Only 7 subjects had MAT-sf measured at baseline and 90 days.

Change in the Mobility Assessment Tool-Short Form (MAT-sf).

5 subjects have CHAMPs data at baseline and 90 days.

Change in CHAMPS Between the Pre- and Post-operative Period

Only 6 subjects reported FACT-G at baseline and 90 days.

Change in Health-related Quality of Life (FACT-G) Questionnaire

Only 6 subjects had pain VAS measured at baseline and 90 days.

Change in Pain Assessment -Pain Visual Analog Scale, (PVAS)

Only 6 subjects reported fatigue VAS at baseline and 90 days.

Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS).

Overall Study

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Cholangiocarcinoma

Adenocarcinoma

Pancreatic Neoplasms

Stomach Neoplasms

Gallbladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Pancreatic Cancer

Bile Duct Cancer

Stomach Cancer

Gallbladder Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Bone Density Conservation Agents

Hematinics

Vitamins

Paclitaxel

Albumin-Bound Paclitaxel

Leucovorin

Fluorouracil

Irinotecan

Levoleucovorin

Calcium

Calcium, Dietary

Tubulin Modulators

Antimitotic Agents

Hormones

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Patients receive FOLFIRABRAX comprising paclitaxel albumin-stabilized nanoparticle formulation IV over 0.5 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 1.5 hours, and fluorouracil IV over 46 hours on days 1 and 15. Courses repeat every 4 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Leucovorin Calcium

Irinotecan Hydrochloride

Laboratory Biomarker Analysis

Manish Sharma

This phase I/II trial studies the side effects of genetic analysis-guided dosing of paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride (FOLFIRABRAX) in treating patients with gastrointestinal cancer that has spread to other parts of the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Genetic analysis may help doctors determine what dose of irinotecan hydrochloride patients can tolerate.

PRIMARY OBJECTIVES:

I. To determine the dose-limiting toxicity (DLT) rate in cycle #1 in each of three uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) genotype groups (\*1/\*1, \*1/\*28, \*28/\*28) using genotype-guided dosing of irinotecan (irinotecan hydrochloride) as part of the FOLFIRABRAX regimen.

SECONDARY OBJECTIVES:

I. To determine the cumulative dose of each chemotherapy drug (nab-paclitaxel \[paclitaxel albumin-stabilized nanoparticle formulation\], irinotecan, 5-FU \[fluorouracil\]) administered in each genotype group.

II. To determine the response rates (in patients with measurable disease) by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) for each different disease (pancreatic cancer, biliary tract cancer, esophageal/gastric cancer, adenocarcinoma of unknown primary) treated in the study.

OUTLINE:

Patients receive FOLFIRABRAX comprising paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 0.5 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 1.5 hours, and fluorouracil IV over 46 hours on days 1 and 15. Courses repeat every 4 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.

Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal Cancer

A Genotype-Guided Dosing Study of FOLFIRABRAX in Previously Untreated Patients With Advanced Gastrointestinal Malignancies

Adverse events will be summarized by type, grade, and attribution.

These results will be compared descriptively to appropriate historical controls. Exact 90% confidence intervals will be generated for the response rates.

The means and standard deviations for patients in each genotype group will be reported.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Consumer-Based Activity Monitor in Evaluating and Measuring Activity of Older Patients With Abdominal Cancer Undergoing Surgery	NCT02356471	Malignant Gastr... Malignant Perit...	Management of T... Questionnaire A... Quality-of-Life...	60 Years - 90 Years	Wake Forest University Health Sciences
Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal Cancer	NCT02333188	Adenocarcinoma ... Adult Cholangio... Gallbladder Car... Gastric Adenoca... Malignant Gastr... Metastatic Panc... Pancreatic Aden... Stage III Ampul... Stage III Pancr... Stage IIIA Gall... Stage IIIA Gast... Stage IIIB Gall... Stage IIIB Gast... Stage IV Ampull... Stage IV Gallbl... Stage IV Gastri... Stage IV Pancre...	Paclitaxel Albu... Leucovorin Calc... Irinotecan Hydr... Fluorouracil Laboratory Biom...	18 Years -	University of Chicago

Spots Global Cancer Trial Database for malignant gastrointestinal neoplasm