Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Purpose
This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.
Conditions
- Colorectal Cancer
- Sarcopenia
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC >= to 3 months (12 weeks) from completion of treatment of non-metastatic CRC. - Planning to or recently started to undergo undergo immunotherapy and/or 5-FU based chemotherapy as a first line of treatment. 5-FU chemotherapy can be 5-FU alone or in combination with oxaliplatin and/or irinotecan +/- immunotherapy. Capecitabine is also acceptable. - Estimated life expectancy >= 6 months. - Patients must be able to comprehend English or Spanish (for questionnaire completion). - Ability to understand and the willingness to sign a written informed consent document. - Patient eligibility is not dependent on BMI or weight. Patients with a significant (+- > 10%) body weight change in the previous 12 months are eligible for this study.
Exclusion Criteria
- Patients enrolled on hospice. - Prior systemic chemotherapy for metastatic colorectal cancer (ok if adjuvant chemotherapy completed >= 3 months (12 weeks) prior to this disease disease recurrence and treatment). - Patients may not be receiving any other investigational agents. - No untreated brain metastases. Patients with treated brain metastases are eligible. - Patients on or planned to undergo radiation therapy in near future.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Adults 60-74 years | ||
| Adults >= 75 years |
Recruiting Locations
Millville 4143696, Delaware 4142224 19967
Newark 4143861, Delaware 4142224 19713
Newark 4143861, Delaware 4142224 19713
Rehoboth Beach 4144284, Delaware 4142224 19971
Wilmington 4145381, Delaware 4142224 19801
Washington D.C. 4140963, District of Columbia 4138106 20007
Site Public Contact
202-444-2223
Columbus 4188985, Georgia 4197000 31904
Bloomington 4885164, Illinois 4896861 61704
Canton 4831990, Illinois 4896861 61520
Carterville 4235311, Illinois 4896861 62918
Chicago 4887398, Illinois 4896861 60612
Site Public Contact
312-864-5204
Danville 4889426, Illinois 4896861 61832
Decatur 4236895, Illinois 4896861 62526
Effingham 4237727, Illinois 4896861 62401
Galesburg 4893392, Illinois 4896861 61401
Mattoon 4244099, Illinois 4896861 61938
Mount Vernon 4245152, Illinois 4896861 62864
Site Public Contact
618-242-4600
Normal 4903780, Illinois 4896861 61761
Normal 4903780, Illinois 4896861 61761
O'Fallon 4245926, Illinois 4896861 62269
Ottawa 4905006, Illinois 4896861 61350
Pekin 4905599, Illinois 4896861 61554
Peoria 4905687, Illinois 4896861 61615
Peru 4905770, Illinois 4896861 61354
Springfield 4250542, Illinois 4896861 62702
Site Public Contact
217-545-7929
Springfield 4250542, Illinois 4896861 62702
Site Public Contact
800-444-7541
Urbana 4914570, Illinois 4896861 61801
Washington 4915545, Illinois 4896861 61571
Ankeny 4846960, Iowa 4862182 50023
515-282-2921
Carroll 4850478, Iowa 4862182 51401
Cedar Rapids 4850751, Iowa 4862182 52402
319-297-2900
Cedar Rapids 4850751, Iowa 4862182 52403
Site Public Contact
319-363-2690
Clive 4852065, Iowa 4862182 50325
515-241-3305
Des Moines 4853828, Iowa 4862182 50309
515-241-6727
Des Moines 4853828, Iowa 4862182 50309
Site Public Contact
515-282-2921
Des Moines 4853828, Iowa 4862182 50314
515-282-2200
Des Moines 4853828, Iowa 4862182 50314
Des Moines 4853828, Iowa 4862182 50314
515-241-3305
Fort Dodge 4857486, Iowa 4862182 50501
Baton Rouge 4315588, Louisiana 4331987 70809
Baton Rouge 4315588, Louisiana 4331987 70809
Baton Rouge 4315588, Louisiana 4331987 70809
Houma 4328010, Louisiana 4331987 70360
Ann Arbor 4984247, Michigan 5001836 48106
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48114
Canton 4987990, Michigan 5001836 48188
Canton 4987990, Michigan 5001836 48188
Chelsea 4988628, Michigan 5001836 48118
Chelsea 4988628, Michigan 5001836 48118
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Iron Mountain 4997232, Michigan 5001836 49801
Livonia 4999837, Michigan 5001836 48154
Pontiac 5006166, Michigan 5001836 48341
Reed City 5006946, Michigan 5001836 49677
Wyoming 5015618, Michigan 5001836 49519
Ypsilanti 5015688, Michigan 5001836 48197
Bemidji 5017822, Minnesota 5037779 56601
Brainerd 5019116, Minnesota 5037779 56401
Coon Rapids 5022025, Minnesota 5037779 55433
Deer River 5024099, Minnesota 5037779 56636
Detroit Lakes 5024237, Minnesota 5037779 56501
Duluth 5024719, Minnesota 5037779 55805
Edina 5025264, Minnesota 5037779 55435
Hibbing 5030005, Minnesota 5037779 55746
218-786-3308
Maplewood 5036588, Minnesota 5037779 55109
Maplewood 5036588, Minnesota 5037779 55109
Minneapolis 5037649, Minnesota 5037779 55407
New Ulm 5039173, Minnesota 5037779 56073
Park Rapids 5040822, Minnesota 5037779 56470
Saint Louis Park 5045021, Minnesota 5037779 55416
Saint Paul 5045360, Minnesota 5037779 55101
Saint Paul 5045360, Minnesota 5037779 55102
Sandstone 5045908, Minnesota 5037779 55072
Shakopee 5046997, Minnesota 5037779 55379
Virginia 5051468, Minnesota 5037779 55792
Willmar 5052916, Minnesota 5037779 56201
Cape Girardeau 4379966, Missouri 4398678 63703
Farmington 4386289, Missouri 4398678 63640
Site Public Contact
314-996-5569
Saint Joseph 4407010, Missouri 4398678 64506
Sainte Genevieve 4407294, Missouri 4398678 63670
Site Public Contact
314-996-5569
Springfield 4409896, Missouri 4398678 65804
Site Public Contact
417-269-4520
Springfield 4409896, Missouri 4398678 65807
417-269-4520
St Louis 4407066, Missouri 4398678 63131
Site Public Contact
314-996-5569
Sullivan 4410669, Missouri 4398678 63080
Site Public Contact
314-996-5569
Sunset Hills 4410836, Missouri 4398678 63127
Site Public Contact
314-996-5569
Charlotte 4460243, North Carolina 4482348 28203
800-804-9376
Charlotte 4460243, North Carolina 4482348 28210
980-442-2000
Charlotte 4460243, North Carolina 4482348 28211
980-442-2000
Charlotte 4460243, North Carolina 4482348 28262
800-804-9376
Clemmons 4461015, North Carolina 4482348 27012
Site Public Contact
888-716-9259
Concord 4461574, North Carolina 4482348 28025
800-804-9376
Gastonia 4467732, North Carolina 4482348 28054
800-804-9376
Wilkesboro 4499138, North Carolina 4482348 28659
888-716-9253
Winston-Salem 4499612, North Carolina 4482348 27157
Site Public Contact
336-713-6771
Bismarck 5688025, North Dakota 5690763 58501
Fargo 5059163, North Dakota 5690763 58103
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
Chillicothe 4828890, Ohio 5165418 45601
Columbus 4509177, Ohio 5165418 43219
Findlay 5153924, Ohio 5165418 45840
Mount Vernon 5163799, Ohio 5165418 43050
Newark 5164466, Ohio 5165418 43055
Portsmouth 4521816, Ohio 5165418 45662
Springfield 4525353, Ohio 5165418 45504
Zanesville 4528923, Ohio 5165418 43701
Danville 5186327, Pennsylvania 6254927 17822
Hazleton 5193011, Pennsylvania 6254927 18201
Lewisburg 5197842, Pennsylvania 6254927 17837
Lewistown 5197850, Pennsylvania 6254927 17044
Pottsville 5207080, Pennsylvania 6254927 17901
Scranton 5211303, Pennsylvania 6254927 18510
Selinsgrove 5211411, Pennsylvania 6254927 17870
State College 5213681, Pennsylvania 6254927 16801
Wilkes-Barre 5219488, Pennsylvania 6254927 18711
Boiling Springs 4571805, South Carolina 4597040 29316
Site Public Contact
864-241-6251
Easley 4577263, South Carolina 4597040 29640
Gaffney 4579418, South Carolina 4597040 29341
Greenville 4580543, South Carolina 4597040 29605
Site Public Contact
864-241-6251
Greenville 4580543, South Carolina 4597040 29605
Site Public Contact
864-241-6251
Greenville 4580543, South Carolina 4597040 29615
Site Public Contact
864-241-6251
Greer 4580599, South Carolina 4597040 29650
Site Public Contact
864-241-6251
Greer 4580599, South Carolina 4597040 29651
Seneca 4595346, South Carolina 4597040 29672
Site Public Contact
864-241-6251
Spartanburg 4597200, South Carolina 4597040 29303
Union 4599214, South Carolina 4597040 29379
Sioux Falls 5231851, South Dakota 5769223 57104
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Ashland 5244247, Wisconsin 5279468 54806
Eau Claire 5251436, Wisconsin 5279468 54701
Green Bay 5254962, Wisconsin 5279468 54301
Green Bay 5254962, Wisconsin 5279468 54303
Marshfield 5261969, Wisconsin 5279468 54449
Minocqua 5263156, Wisconsin 5279468 54548
Rice Lake 5268798, Wisconsin 5279468 54868
Spooner 5274034, Wisconsin 5279468 54801
Stevens Point 5274644, Wisconsin 5279468 54482
Sturgeon Bay 5274867, Wisconsin 5279468 54235-1495
Weston 5278693, Wisconsin 5279468 54476
More Details
- NCT ID
- NCT03998202
- Status
- Recruiting
- Sponsor
- Wake Forest University Health Sciences
Detailed Description
This is a prospective cohort study that examines the impact of myopenia on chemotherapy toxicity in overall survival (OS) in older adults with newly diagnosed metastatic colorectal cancer (CRC) receiving 5-Fluouracil (5FU)systemic chemotherapy. The study also explores the mediating influence of genetic variation in the association between myopenia and chemotherapy toxicity.