Creatine in Treating Patients With Cancer-Associated Weight Loss

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00081250
Collaborator
National Cancer Institute (NCI) (NIH)
300
220
2
151
1.4
0

Study Details

Study Description

Brief Summary

RATIONALE: It is not yet known whether the supplement creatine is effective in increasing weight and improving appetite and quality of life in patients who have cancer.

PURPOSE: This randomized phase III trial is studying how well creatine works in increasing weight and improving appetite and quality of life in patients with weight loss caused by cancer.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: creatine monohydrate
  • Other: placebo
Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
Actual Study Start Date :
Dec 1, 2004
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

Patients receive oral creatine daily.

Dietary Supplement: creatine monohydrate
Given orally

Placebo Comparator: Arm II

Patients receive oral placebo daily.

Other: placebo
Given orally

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients who gain weight over 1 month [1 month]

Secondary Outcome Measures

  1. Percentage of patients who manifest weight stability (i.e., weight within 5% of baseline) at 1 month [1 month]

  2. Percentage of patients who manifest stability in appetite [Up to 5 years]

  3. Overall survival [Up to 5 years]

  4. Incidence of treatment-related toxicity [Up to 5 years]

  5. Quality of life [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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:

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

Other

  • No prior creatine use

  • No concurrent tube feedings or parenteral nutrition

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mobile Infirmary Medical Center Mobile Alabama United States 36652-2144
2 Mayo Clinic Scottsdale Scottsdale Arizona United States 85259-5499
3 Aurora Presbyterian Hospital Aurora Colorado United States 80012
4 Boulder Community Hospital Boulder Colorado United States 80301-9019
5 Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado United States 80933
6 St. Anthony Central Hospital Denver Colorado United States 80204
7 Porter Adventist Hospital Denver Colorado United States 80210
8 Presbyterian - St. Luke's Medical Center Denver Colorado United States 80218
9 St. Joseph Hospital Denver Colorado United States 80218
10 Rose Medical Center Denver Colorado United States 80220
11 CCOP - Colorado Cancer Research Program Denver Colorado United States 80224-2522
12 Swedish Medical Center Englewood Colorado United States 80110
13 St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction Colorado United States 81502
14 North Colorado Medical Center Greeley Colorado United States 80631
15 Sky Ridge Medical Center Lone Tree Colorado United States 80124
16 Hope Cancer Care Center at Longmont United Hospital Longmont Colorado United States 80502
17 McKee Medical Center Loveland Colorado United States 80539
18 St. Mary - Corwin Regional Medical Center Pueblo Colorado United States 81004
19 North Suburban Medical Center Thornton Colorado United States 80229
20 Exempla Lutheran Medical Center Wheat Ridge Colorado United States 80033
21 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224
22 MBCCOP - Medical College of Georgia Cancer Center Augusta Georgia United States 30912
23 Tripler Army Medical Center Honolulu Hawaii United States 96859
24 Rush-Copley Cancer Care Center Aurora Illinois United States 60507
25 St. Joseph Medical Center Bloomington Illinois United States 61701
26 Graham Hospital Canton Illinois United States 61520
27 Memorial Hospital Carthage Illinois United States 62321
28 Eureka Community Hospital Eureka Illinois United States 61530
29 Galesburg Clinic, PC Galesburg Illinois United States 61401
30 Galesburg Cottage Hospital Galesburg Illinois United States 61401
31 Mason District Hospital Havana Illinois United States 62644
32 Hopedale Medical Complex Hopedale Illinois United States 61747
33 Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois United States 60435
34 Kewanee Hospital Kewanee Illinois United States 61443
35 McDonough District Hospital Macomb Illinois United States 61455
36 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline Illinois United States 61265
37 Moline Illinois United States 61265
38 BroMenn Regional Medical Center Normal Illinois United States 61761
39 Community Cancer Center Normal Illinois United States 61761
40 Community Hospital of Ottawa Ottawa Illinois United States 61350
41 Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois United States 61350
42 Cancer Treatment Center at Pekin Hospital Pekin Illinois United States 61554
43 Proctor Hospital Peoria Illinois United States 61614
44 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615
45 Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois United States 61615
46 Methodist Medical Center of Illinois Peoria Illinois United States 61636
47 OSF St. Francis Medical Center Peoria Illinois United States 61637
48 Illinois Valley Community Hospital Peru Illinois United States 61354
49 Perry Memorial Hospital Princeton Illinois United States 61356
50 St. Margaret's Hospital Spring Valley Illinois United States 61362
51 Carle Cancer Center at Carle Foundation Hospital Urbana Illinois United States 61801
52 CCOP - Carle Cancer Center Urbana Illinois United States 61801
53 St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana United States 46107
54 Elkhart General Hospital Elkhart Indiana United States 46515
55 Howard Community Hospital Kokomo Indiana United States 46904
56 Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana United States 46350
57 Saint Anthony Memorial Health Centers Michigan City Indiana United States 46360
58 Reid Hospital & Health Care Services Richmond Indiana United States 47374
59 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
60 Memorial Hospital of South Bend South Bend Indiana United States 46601
61 Saint Joseph Regional Medical Center South Bend Indiana United States 46617
62 Bettendorf Iowa United States 52722
63 Cedar Rapids Oncology Associates Cedar Rapids Iowa United States 52403
64 Mercy Capitol Hospital Des Moines Iowa United States 50307
65 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309
66 John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa United States 50309
67 Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa United States 50309
68 Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa United States 50314
69 Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
70 John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa United States 50316
71 Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City Iowa United States 50401
72 McCreery Cancer Center at Ottumwa Regional Ottumwa Iowa United States 52501
73 Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa United States 51101
74 Mercy Medical Center - Sioux City Sioux City Iowa United States 51104
75 St. Luke's Regional Medical Center Sioux City Iowa United States 51104
76 Cancer Center of Kansas, PA - Chanute Chanute Kansas United States 66720
77 Cancer Center of Kansas, PA - Dodge City Dodge City Kansas United States 67801
78 Cancer Center of Kansas, PA - El Dorado El Dorado Kansas United States 67042
79 Cancer Center of Kansas, PA - Kingman Kingman Kansas United States 67068
80 Southwest Medical Center Liberal Kansas United States 67901
81 Cancer Center of Kansas, PA - Newton Newton Kansas United States 67114
82 Cancer Center of Kansas, PA - Parsons Parsons Kansas United States 67357
83 Cancer Center of Kansas, PA - Pratt Pratt Kansas United States 67124
84 Cancer Center of Kansas, PA - Salina Salina Kansas United States 67042
85 Cancer Center of Kansas, PA - Wellington Wellington Kansas United States 67152
86 Associates in Womens Health, PA - North Review Wichita Kansas United States 67203
87 Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas United States 67208
88 Cancer Center of Kansas, PA - Wichita Wichita Kansas United States 67214
89 CCOP - Wichita Wichita Kansas United States 67214
90 Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas United States 67214
91 Cancer Center of Kansas, PA - Winfield Winfield Kansas United States 67156
92 Ochsner Health Center - Bluebonnet Baton Rouge Louisiana United States 708169990
93 Terrebonne General Medical Center Houma Louisiana United States 70360
94 CCOP - Ochsner New Orleans Louisiana United States 70121
95 Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans Louisiana United States 70121
96 Hickman Cancer Center at Bixby Medical Center Adrian Michigan United States 49221
97 Saint Joseph Mercy Cancer Center Ann Arbor Michigan United States 48106-0995
98 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
99 Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan United States 48123-2500
100 Genesys Hurley Cancer Institute Flint Michigan United States 48503
101 Hurley Medical Center Flint Michigan United States 48503
102 Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan United States 48236
103 Foote Hospital Jackson Michigan United States 49201
104 Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville Michigan United States 48144
105 Sparrow Regional Cancer Center Lansing Michigan United States 48912-1811
106 Community Cancer Center of Monroe Monroe Michigan United States 48162
107 Mercy Memorial Hospital - Monroe Monroe Michigan United States 48162
108 Seton Cancer Institute - Saginaw Saginaw Michigan United States 48601
109 Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan United States 49085
110 St. John Macomb Hospital Warren Michigan United States 48093
111 MeritCare Bemidji Bemidji Minnesota United States 56601
112 Fairview Ridges Hospital Burnsville Minnesota United States 55337
113 Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota United States 55433
114 Duluth Clinic Cancer Center - Duluth Duluth Minnesota United States 55805-1983
115 CCOP - Duluth Duluth Minnesota United States 55805
116 Miller - Dwan Medical Center Duluth Minnesota United States 55805
117 Fairview Southdale Hospital Edina Minnesota United States 55435
118 Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota United States 55432
119 Immanuel St. Joseph's Mankato Minnesota United States 56002
120 Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota United States 55109
121 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota United States 55407
122 Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota United States 55422-2900
123 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
124 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
125 Park Nicollet Cancer Center Saint Louis Park Minnesota United States 55416
126 United Hospital Saint Paul Minnesota United States 55102
127 Ridgeview Medical Center Waconia Minnesota United States 55387
128 Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota United States 55125
129 Hattiesburg Clinic, PA at Forrest General Hattiesburg Mississippi United States 39401
130 Hematology & Oncology Clinic Hattiesburg Mississippi United States 39402
131 Missouri Baptist Cancer Center Saint Louis Missouri United States 63131
132 Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis Missouri United States 63141
133 CCOP - Montana Cancer Consortium Billings Montana United States 59101
134 Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana United States 59101
135 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
136 St. Vincent Healthcare Cancer Care Services Billings Montana United States 59101
137 Billings Clinic Cancer Center Billings Montana United States 59107-5100
138 Billings Clinic - Downtown Billings Montana United States 59107-7000
139 Bozeman Deaconess Cancer Center Bozeman Montana United States 59715
140 St. James Healthcare Cancer Care Butte Montana United States 59701
141 Big Sky Oncology Great Falls Montana United States 59405-5309
142 Great Falls Clinic - Main Facility Great Falls Montana United States 59405
143 Great Falls Montana United States 59405
144 St. Peter's Hospital Helena Montana United States 59601
145 Glacier Oncology, PLLC Kalispell Montana United States 59901
146 Kalispell Medical Oncology at KRMC Kalispell Montana United States 59901
147 Kalispell Regional Medical Center Kalispell Montana United States 59901
148 Community Medical Center Missoula Montana United States 59801
149 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
150 Montana Cancer Specialists at Montana Cancer Center Missoula Montana United States 59807-7877
151 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana United States 59807
152 Cancer Resource Center - Lincoln Lincoln Nebraska United States 68510
153 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
154 Immanuel Medical Center Omaha Nebraska United States 68122
155 Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha Nebraska United States 68124
156 Creighton University Medical Center Omaha Nebraska United States 68131-2197
157 Bismarck Cancer Center Bismarck North Dakota United States 58501
158 Medcenter One Hospital Cancer Care Center Bismarck North Dakota United States 58501
159 Mid Dakota Clinic, PC Bismarck North Dakota United States 58501
160 St. Alexius Medical Center Cancer Center Bismarck North Dakota United States 58502
161 CCOP - MeritCare Hospital Fargo North Dakota United States 58122
162 MeritCare Broadway Fargo North Dakota United States 58122
163 Wood County Oncology Center Bowling Green Ohio United States 43402
164 Adena Regional Medical Center Chillicothe Ohio United States 45601
165 Riverside Methodist Hospital Cancer Care Columbus Ohio United States 43214-3998
166 CCOP - Columbus Columbus Ohio United States 43215
167 Grant Medical Center Cancer Care Columbus Ohio United States 43215
168 Mount Carmel Health - West Hospital Columbus Ohio United States 43222
169 Doctors Hospital at Ohio Health Columbus Ohio United States 43228
170 Grandview Hospital Dayton Ohio United States 45405
171 Good Samaritan Hospital Dayton Ohio United States 45406
172 David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio United States 45409
173 Samaritan North Cancer Care Center Dayton Ohio United States 45415
174 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
175 CCOP - Dayton Dayton Ohio United States 45429
176 Grady Memorial Hospital Delaware Ohio United States 43015
177 Blanchard Valley Medical Associates Findlay Ohio United States 45840
178 Fremont Memorial Hospital Fremont Ohio United States 43420
179 Charles F. Kettering Memorial Hospital Kettering Ohio United States 45429
180 Fairfield Medical Center Lancaster Ohio United States 43130
181 Lima Memorial Hospital Lima Ohio United States 45804
182 Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio United States 45750
183 Northwest Ohio Oncology Center Maumee Ohio United States 43537
184 St. Luke's Hospital Maumee Ohio United States 43537
185 Middletown Regional Hospital Middletown Ohio United States 45044
186 Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio United States 43055
187 St. Charles Mercy Hospital Oregon Ohio United States 43616
188 Toledo Clinic - Oregon Oregon Ohio United States 43616
189 Firelands Regional Medical Center Sandusky Ohio United States 44870
190 North Coast Cancer Care, Incorporated Sandusky Ohio United States 44870
191 Mercy Medical Center Springfield Ohio United States 45504
192 Community Hospital of Springfield and Clark County Springfield Ohio United States 45505
193 Flower Hospital Cancer Center Sylvania Ohio United States 43560
194 Mercy Hospital of Tiffin Tiffin Ohio United States 44883
195 Toledo Hospital Toledo Ohio United States 43606
196 St. Vincent Mercy Medical Center Toledo Ohio United States 43608
197 Medical University of Ohio Cancer Center Toledo Ohio United States 43614
198 CCOP - Toledo Community Hospital Toledo Ohio United States 43617
199 Toledo Clinic, Incorporated - Main Clinic Toledo Ohio United States 43623
200 UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio United States 45373-1300
201 Fulton County Health Center Wauseon Ohio United States 43567
202 Mount Carmel St. Ann's Cancer Center Westerville Ohio United States 43081
203 United States Air Force Medical Center - Wright-Patterson Wright-Patterson Air Force Base Ohio United States 45433-5529
204 Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio United States 45385
205 Genesis - Good Samaritan Hospital Zanesville Ohio United States 43701
206 Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma United States 74136
207 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania United States 18105
208 Geisinger Medical Center Danville Pennsylvania United States 17822-0001
209 Geisinger Medical Group - Scenery Park State College Pennsylvania United States 16801
210 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania United States 18711
211 Avera Cancer Institute Sioux Falls South Dakota United States 57105
212 Medical X-Ray Center, PC Sioux Falls South Dakota United States 57105
213 Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota United States 57117-5039
214 Fredericksburg Oncology, Incorporated Fredericksburg Virginia United States 22401
215 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54301-3526
216 Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin United States 54303
217 St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin United States 54303
218 St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54307-3508
219 Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin United States 54143
220 Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming United States 82801

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Aminah Jatoi, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00081250
Other Study ID Numbers:
  • NCCTG-N02C4
  • NCI-2012-02584
  • CDR0000360798
First Posted:
Apr 8, 2004
Last Update Posted:
Apr 29, 2020
Last Verified:
Apr 1, 2020
Keywords provided by Alliance for Clinical Trials in Oncology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2020