Creatine in Treating Patients With Cancer-Associated Weight Loss - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00081250

Purpose

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	Intervention	Phase
Anorexia Cachexia Unspecified Adult Solid Tumor, Protocol Specific Weight Changes	Dietary Supplement: creatine Other: placebo	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Weight Control

Drug Information available for: Creatine Creatine monohydrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Percentage of patients who gain weight over 1 month [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients who manifest weight stability (i.e., weight within 5% of baseline) at 1 month [ Designated as safety issue: No ]
Percentage of patients who manifest stability in appetite [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Incidence of treatment-related toxicity [ Designated as safety issue: Yes ]
Quality of life [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	December 2004

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral creatine daily.	Dietary Supplement: creatine Given orally
Arm II: Placebo Comparator Patients receive oral placebo daily.	Other: placebo Given orally

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081250

Show 223 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Aminah Jatoi, MD	Mayo Clinic
Investigator:	Charles L. Loprinzi, MD	Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000360798, NCCTG-N02C4
Study First Received:	April 7, 2004
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00081250 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific
cachexia
anorexia
weight changes

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive
Weight Loss

Body Weight Changes
Anorexia
Cachexia
Emaciation

ClinicalTrials.gov processed this record on November 05, 2009