Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00070148

Purpose

RATIONALE: Oxandrolone and megestrol may help prevent weight loss and improve quality of life in patients with cancer. It is not yet known whether oxandrolone is more effective than megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors.

PURPOSE: This randomized phase III trial is studying oxandrolone to see how well it works compared to megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific Weight Changes	Drug: megestrol acetate Drug: oxandrolone Procedure: quality-of-life assessment	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
Official Title:	A Phase III Randomized Study Comparing The Effects Of Oxandrolone (Oxandrin) And Megestrol Acetate (Megace) On Lean Body Mass, Weight, Body Fat, And Quality Of Life In Patients With Solid Tumors And Weight Loss Receiving Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Weight Control

Drug Information available for: Oxandrolone Megestrol acetate Megestrol

U.S. FDA Resources

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

Primary Outcome Measures:

Lean body mass as measured by the Bioelectrical Impedance Analysis monthly

Secondary Outcome Measures:

Weight
Body fat as measured by the Bioelectrical Impedance Analysis monthly
Health-related quality of life as measured by the Functional Assessment of Cancer Therapy with subscales for anorexia/cachexia and fatigue
Performance status as measured by ECOG criteria
Toxicity as measured by standard NCI toxicity criteria

Estimated Enrollment:	155
Study Start Date:	March 2004

Detailed Description:

OBJECTIVES:

Compare the lean body mass and weight of patients with solid tumors and weight loss who are receiving chemotherapy when treated with oxandrolone vs megestrol.
Compare the health-related quality of life of patients treated with these drugs.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (I-III vs IV), concurrent radiotherapy (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral oxandrolone twice daily.
Arm II: Patients receive oral megestrol once daily. In both arms, treatment continues for 12 weeks in the absence of excessive weight loss or gain or unacceptable toxicity.

Quality of life, weight, and body composition are assessed at baseline, at 1, 2, and 3 months during study therapy, and then at 1 month after study completion.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 62-155 patients (31-77 per treatment arm) will be accrued for this study within 2 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed solid tumor, excluding any of the following:
- Breast cancer
  - Female breast cancer allowed if disease free ≥ 5 years
- Ovarian cancer
- Prostate cancer
- Gynecologic or hormonally responsive germ cell tumors within the past 5 years
- Primary or metastatic malignant brain tumors unless they have been stable or demonstrate no evidence of disease within the past 6 months
- Leukemia
- Lymphoma
- Myeloma
- Other hematologic malignancies
Currently receiving chemotherapy
Weight loss meeting criteria for 1 of the following:
- At least 5% total body weight loss within the past 6 months
- At least 3% weight loss within the past month
- Progressive weight loss on 2 consecutive visits despite dietary, behavioral, or pharmacologic intervention
Body Mass Index no greater than 35
No significant ascites, pleural effusion, or edema that would preclude oral food intake or invalidate weight determinations

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

At least 6 months

Hematopoietic

Not specified

Hepatic

SGOT and SGPT no greater than 2 times upper limit of normal
Bilirubin no greater than 2.5 mg/dL

Renal

Creatinine no greater than 2.5 mg/dL
No hypercalcemia
No nephrosis or nephrotic phase of nephritis

Cardiovascular

No uncontrolled hypertension
No congestive heart failure
No unstable angina
No myocardial infarction within the past 3 months
No active thromboembolic disease within the past 6 months

Pulmonary

No pulmonary edema

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other pre-existing or uncontrolled medical condition that would preclude study participation or giving informed consent
No psychological illness that would preclude study participation or giving informed consent
No Cushing's syndrome
No uncontrolled diabetes (i.e., HbA1C greater than 10%)
Prostate-specific antigen no greater than 4 ng/mL (men age 40 and over)
Able to swallow 8 small tablets or 20 cc of liquid daily
Able to meet nutritional requirements orally (with food or supplements) or enteral tube feedings

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

More than 3 months since prior oxandrolone or megestrol
No concurrent corticosteroids
- Concurrent intermittent corticosteroids as part of a pre-chemotherapy antiemetic regimen are allowed
No concurrent estrogens
No other concurrent progestins (including megestrol)
No other concurrent steroid hormone
No concurrent sulfonyureas (e.g., glimepiride, glyburide, chlorpropamide, glipizide, combined glyburide and metformin, and orinase)

Radiotherapy

Concurrent radiotherapy allowed

Surgery

Not specified

Other

No concurrent oral anticoagulants (e.g., warfarin) for systemic anticoagulation
- Concurrent warfarin for maintenance of central venous catheter patency allowed provided INR is no greater than 1.2
No concurrent oral hypoglycemic agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070148

Locations

United States, Delaware
Helen F. Graham Cancer Center at Christiana Care
Newark, Delaware, United States, 19713
United States, Florida
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
United States, Kentucky
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, United States, 40202
United States, Louisiana
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70118
Pennington Cancer Center at Baton Rouge General
Baton Rouge, Louisiana, United States, 70806
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
High Point Regional Hospital
High Point, North Carolina, United States, 27261
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States, 27835-6028
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, United States, 27216
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27403-1198
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, United States, 27534
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43215
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
Martinsville, Virginia, United States, 24115-4788

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:	Edward G. Shaw, MD	Wake Forest University
Investigator:	Glenn J. Lesser, MD	Wake Forest University

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:	CDR0000330073, CCCWFU-0103, CCCWFU-97102
Study First Received:	October 3, 2003
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00070148 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

weight changes
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Quality of Life
Central Nervous System Stimulants
Hormones
Megestrol

Oxandrolone
Body Weight
Signs and Symptoms
Anabolic Agents
Weight Loss
Body Weight Changes
Megestrol Acetate
Appetite Stimulants
Androgens

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Contraceptive Agents
Antineoplastic Agents
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Central Nervous System Stimulants
Reproductive Control Agents
Hormones
Megestrol
Pharmacologic Actions

Oxandrolone
Body Weight
Signs and Symptoms
Anabolic Agents
Therapeutic Uses
Weight Loss
Body Weight Changes
Contraceptives, Oral, Synthetic
Central Nervous System Agents
Megestrol Acetate
Appetite Stimulants
Androgens

ClinicalTrials.gov processed this record on September 03, 2009