Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Anorexia, Cachexia, Unspecified Adult Solid Tumor, Protocol Specific, Weight Changes
Both
Anorexia, Cachexia, Unspecified Adult Solid Tumor, Protocol Specific, Weight Changes
Trial Information
Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
OBJECTIVES:
- Compare weight-gain effects of creatine vs placebo in patients with cancer-associated
weight loss and/or anorexia.
- Determine the effect of these regimens on quality of life in these patients.
- Compare the toxic effects of these regimens in these patients.
- Compare survival rates of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to primary cancer type (lung vs gastrointestinal vs other), weight loss
severity (< 10 lbs vs ≥10 lbs), age (< 50 years vs ≥ 50 years), planned concurrent
chemotherapy (yes vs no), gender, and prognosis. Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients receive oral creatine daily.
- Arm II: Patients receive oral placebo daily. In both arms, treatment continues in the
absence of unacceptable toxicity as long as treatment is considered beneficial.
Patients are followed every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed cancer other than primary brain cancer
- Considered incurable with available therapies
- History of weight loss ≥ 5 lbs in 2 months or fewer AND/OR estimated intake of < 20
cal/kg daily
- Determination by attending physician that weight gain would benefit patient
- Perception by patient that weight loss is a problem
- No symptomatic or untreated brain metastases
- No clinical evidence of ascites
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Creatinine normal
Cardiovascular
- No poorly controlled congestive heart failure
- No poorly controlled hypertension
Other
- Able to reliably receive oral medication
- Must be alert and mentally competent
- No known obstruction of the alimentary tract, malabsorption, or intractable vomiting
- No diabetes that is controlled by insulin
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Concurrent chemotherapy allowed
Endocrine therapy
- No other concurrent adrenal corticosteroids, androgens, or progestational agents
within 30 days after study entry
- Concurrent short-term dexamethasone for chemotherapy-associated emesis is allowed
- Concurrent inhalant, topical, or optical steroids allowed
Radiotherapy
- No concurrent radiotherapy to the bowel or stomach
- Other concurrent radiotherapy allowed
Surgery
- Not specified
Other
- No prior creatine use
- No concurrent tube feedings or parenteral nutrition
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Percentage of patients who gain weight over 1 month
Safety Issue:
No
Principal Investigator
Aminah Jatoi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000360798
NCT ID:
NCT00081250
Start Date:
December 2004
Completion Date:
Related Keywords:
- Anorexia
- Cachexia
- Unspecified Adult Solid Tumor, Protocol Specific
- Weight Changes
- unspecified adult solid tumor, protocol specific
- cachexia
- anorexia
- weight changes
- Anorexia
- Body Weight Changes
- Cachexia
- Weight Loss
Name | Location |
|---|---|
| Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| Hurley Medical Center | Flint, Michigan 48503 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
| Boulder Community Hospital | Boulder, Colorado 80301-9019 |
| Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
| CCOP - Colorado Cancer Research Program | Denver, Colorado 80224-2522 |
| Porter Adventist Hospital | Denver, Colorado 80210 |
| Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
| St. Joseph Hospital | Denver, Colorado 80218 |
| Rose Medical Center | Denver, Colorado 80220 |
| Swedish Medical Center | Englewood, Colorado 80110 |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
| Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
| Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
| St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
| North Suburban Medical Center | Thornton, Colorado 80229 |
| Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
| Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
| Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
| St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Foote Hospital | Jackson, Michigan 49201 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| MeritCare Bemidji | Bemidji, Minnesota 56601 |
| Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
| Duluth Clinic Cancer Center - Duluth | Duluth, Minnesota 55805-1983 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
| Fairview Southdale Hospital | Edina, Minnesota 55435 |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
| Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
| United Hospital | St. Paul, Minnesota 55102 |
| Ridgeview Medical Center | Waconia, Minnesota 55387 |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
| MeritCare Broadway | Fargo, North Dakota 58122 |
| CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
| Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
| Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
| Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
| Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| Hinsdale, Illinois 60521 | |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
| St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
| Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
| Toledo Hospital | Toledo, Ohio 43606 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
| North Colorado Medical Center | Greeley, Colorado 80631 |
| McKee Medical Center | Loveland, Colorado 80539 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
| Big Sky Oncology | Great Falls, Montana 59405 |
| St. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Regional Medical Center | Kalispell, Montana 59901 |
| Glacier Oncology, PLLC | Kalispell, Montana 59901 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
| Community Medical Center | Missoula, Montana 59801 |
| Adena Regional Medical Center | Chillicothe, Ohio 54601 |
| Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Grady Memorial Hospital | Delaware, Ohio 43015 |
| Fairfield Medical Center | Lancaster, Ohio 43130 |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
| Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
| Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Howard Community Hospital | Kokomo, Indiana 46904 |
| Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
| Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
| St. Joseph Medical Center | Bloomington, Illinois 61701 |
| Graham Hospital | Canton, Illinois 61520 |
| Memorial Hospital | Carthage, Illinois 62321 |
| Eureka Community Hospital | Eureka, Illinois 61530 |
| Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
| Mason District Hospital | Havana, Illinois 62644 |
| Hopedale Medical Complex | Hopedale, Illinois 61747 |
| Kewanee Hospital | Kewanee, Illinois 61443 |
| McDonough District Hospital | Macomb, Illinois 61455 |
| BroMenn Regional Medical Center | Normal, Illinois 61761 |
| Community Cancer Center | Normal, Illinois 61761 |
| Community Hospital of Ottawa | Ottawa, Illinois 61350 |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
| Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
| OSF St. Francis Medical Center | Peoria, Illinois 61637 |
| Proctor Hospital | Peoria, Illinois 61614 |
| Illinois Valley Community Hospital | Peru, Illinois 61354 |
| Perry Memorial Hospital | Princeton, Illinois 61356 |
| St. Margaret's Hospital | Spring Valley, Illinois 61362 |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| Bettendorf, Iowa 52722 | |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
| Mercy Capitol Hospital | Des Moines, Iowa 50307 |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
| Terrebonne General Medical Center | Houma, Louisiana 70360 |
| Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
| Community Cancer Center of Monroe | Monroe, Michigan 48162 |
| Immanuel Medical Center | Omaha, Nebraska 68122 |
| Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
| Bismarck Cancer Center | Bismarck, North Dakota 58501 |
| Wood County Oncology Center | Bowling Green, Ohio 43402 |
| Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
| Grandview Hospital | Dayton, Ohio 45405 |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
| Good Samaritan Hospital | Dayton, Ohio 45406 |
| Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
| Fremont Memorial Hospital | Fremont, Ohio 43420 |
| Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
| Lima Memorial Hospital | Lima, Ohio 45804 |
| St. Luke's Hospital | Maumee, Ohio 43537 |
| Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
| Middletown Regional Hospital | Middletown, Ohio 45044 |
| Toledo Clinic - Oregon | Oregon, Ohio 43616 |
| St. Charles Mercy Hospital | Oregon, Ohio 43616 |
| North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
| Firelands Regional Medical Center | Sandusky, Ohio 44870 |
| Mercy Medical Center | Springfield, Ohio 45504 |
| Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
| Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
| Fulton County Health Center | Wauseon, Ohio 43567 |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
| St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
| Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
| Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
| Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
| Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
| Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
| Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
| Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
| Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
| Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
| Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
| Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
| Ochsner Health Center - Bluebonnet | Baton Rouge, Louisiana 70809 |
| Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville, Michigan 48144 |
| Mercy Memorial Hospital - Monroe | Monroe, Michigan 48162 |
| Arch Medical Services, Incorporated at Center for Cancer Care and Research | Saint Louis, Missouri 63141 |
| Billings Clinic - Downtown | Billings, Montana 59107-7000 |
| Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
| St. James Healthcare Cancer Care | Butte, Montana 59701 |
| Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
| Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
| Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
| Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
| Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
| Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
| Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
| Billings Clinic Cancer Center | Billings, Montana 59107-5100 |
| Great Falls, Montana 59405 | |
| Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
| Galesburg Clinic, PC | Galesburg, Illinois 61401 |
| St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
| Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline, Illinois 61265 |
| Hattiesburg Clinic, PA at Forrest General | Hattiesburg, Mississippi 39401 |
| United States Air Force Medical Center - Wright-Patterson | Wright-Patterson AFB, Ohio 45433-5529 |
| Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
| St. Alexius Medical Center Cancer Center | Bismarck, North Dakota 58502 |
| Immanuel St. Joseph's | Mankato, Minnesota 56002 |
| Hematology & Oncology Clinic | Hattiesburg, Mississippi 39402 |
