Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00031707

Collaborator

National Cancer Institute (NCI) (NIH), NCIC Clinical Trials Group (Other)

429

Enrollment

Locations

Arms

Duration (Months)

9.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may improve cancer-related weight loss and lack of appetite. It is not yet known whether megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a combination of both is most effective in treating cancer-related weight loss and loss of appetite.

PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Cachexia	Dietary Supplement: eicosapentaenoic acid Drug: megestrol acetate Other: placebo	Phase 3

Detailed Description

OBJECTIVES:

Compare the appetite-stimulating properties of megestrol vs an eicosapentaenoic acid-enriched nutritional supplement vs both, in terms of patient weight, rate of weight change, and appetite, in patients with cancer-related cachexia and anorexia.
Determine the effect of these regimens on nausea and vomiting in these patients.
Assess quality of life in patients treated with these regimens.
Determine the toxic effects of these regimens in these patients.
Compare overall survival of patients treated with these regimens.
Correlate interleukin-6 concentration changes with appetite and weight changes in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to primary cancer (lung vs gastrointestinal vs other), severity of weight loss in the past 2 months (less than 10 pounds vs 10 pounds or more), planned concurrent chemotherapy (yes vs no), age (under 50 vs 50 and over), and prognosis (good vs bad vs unsure). Patients are randomized to 1 of 3 treatment arms.

Study Design

Study Type:

Interventional

Actual Enrollment :

429 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 Megestrol Acetate (Megace) Versus an N-3 Fatty Acid (EPA) Enriched Nutritional Supplement Versus Both for the Treatment of Cancer Cachexia and Anorexia

Study Start Date :

Mar 1, 2000

Actual Primary Completion Date :

Jan 1, 2004

Actual Study Completion Date :

Jan 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: megestrol + placebo Patients receive oral megestrol once daily and oral placebo twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial. Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment. Patients are followed every 6 months for 5 years.	Drug: megestrol acetate Other: placebo
Active Comparator: eicosapentaenoic acid + placebo Patients receive oral placebo once daily and an eicosapentaenoic acid (EPA)-enriched nutritional supplement twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial. Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment. Patients are followed every 6 months for 5 years.	Dietary Supplement: eicosapentaenoic acid Other: placebo
Experimental: megestrol + eicosapentaenoic acid Patients receive oral megestrol once daily and an EPA-enriched nutritional supplement twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial. Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment. Patients are followed every 6 months for 5 years.	Dietary Supplement: eicosapentaenoic acid Drug: megestrol acetate

Arm

Intervention/Treatment

Active Comparator: megestrol + placebo

Patients receive oral megestrol once daily and oral placebo twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial. Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment. Patients are followed every 6 months for 5 years.

Drug: megestrol acetate

Other: placebo

Active Comparator: eicosapentaenoic acid + placebo

Patients receive oral placebo once daily and an eicosapentaenoic acid (EPA)-enriched nutritional supplement twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial. Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment. Patients are followed every 6 months for 5 years.

Dietary Supplement: eicosapentaenoic acid

Other: placebo

Experimental: megestrol + eicosapentaenoic acid

Patients receive oral megestrol once daily and an EPA-enriched nutritional supplement twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial. Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment. Patients are followed every 6 months for 5 years.

Dietary Supplement: eicosapentaenoic acid

Drug: megestrol acetate

Outcome Measures

Primary Outcome Measures

Compare the appetite-stimulating properties (eg, patient weight, rate of weight change, and appetite) [Up to 5 years]

Secondary Outcome Measures

Assess quality of life [Up to 5 years]
Overall survival [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically or cytologically proven cancer other than brain, breast, ovarian, endometrial, or prostate cancer
Compelling clinical evidence of cancer is allowed when tissue sample is unobtainable
Considered incurable with available therapies
At least 5 pounds weight loss within the past 2 months (excluding perioperative weight loss) and/or have estimated caloric intake of less than 20 cal/kg daily
Weight loss must be perceived as a problem by the patient
Potential weight gain must be considered beneficial by the attending physician
No history of primary brain cancer or brain metastases
No clinical evidence of ascites

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

At least 3 months

Cardiovascular:

No poorly controlled congestive heart failure
No poorly controlled hypertension
No history of thromboembolic disease

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
Alert and mentally competent
Able to reliably take oral medication
No known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (more than 5 episodes per week)
No diabetes requiring insulin
Diabetes requiring an oral hypoglycemic agent or diet control allowed

PRIOR CONCURRENT THERAPY:

Chemotherapy:

Concurrent chemotherapy allowed

Endocrine therapy:

At least 1 month since prior adrenal steroids, androgens, progestational agents, or appetite stimulants (e.g., dronabinol)
No concurrent adrenal steroids, androgens, other progestational agents, or appetite stimulants (e.g., dronabinol)
Inhalant, topical, or optical steroids allowed
Short-term dexamethasone as an anti-emetic during chemotherapy allowed

Radiotherapy:

Concurrent radiotherapy allowed

Other:

No tube feedings or parenteral nutrition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	Mayo Clinic	Jacksonville	Florida	United States	32224
3	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
4	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
5	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
6	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
7	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
8	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
9	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
10	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
11	CCOP - Duluth	Duluth	Minnesota	United States	55805
12	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
13	CentraCare Health Plaza	Saint Cloud	Minnesota	United States	56303
14	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
15	Medcenter One Health System	Bismarck	North Dakota	United States	58501
16	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
17	Altru Health Systems	Grand Forks	North Dakota	United States	58201
18	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
19	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania	United States	17822-2001
20	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212-4772
21	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
22	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57104
23	Tom Baker Cancer Center - Calgary	Calgary	Alberta	Canada	T2N 4N2
24	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
25	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia	Canada	V1Y 5L3
26	Nanaimo Cancer Clinic	Nanaimo	British Columbia	Canada	V9S 2B7
27	British Columbia Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6
28	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
29	Saint John Regional Hospital	Saint John	New Brunswick	Canada	E2L 4L2
30	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador	Canada	A1B 3V6
31	William Osler Health Centre	Brampton	Ontario	Canada	L6W 2Z8
32	Cancer Care Ontario-Hamilton Regional Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
33	Kingston Regional Cancer Centre	Kingston	Ontario	Canada	K7L 5P9
34	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario	Canada	N6A 4L6
35	Trillium Health Centre	Mississauga	Ontario	Canada	L5B 1B8
36	Ottawa Regional Cancer Centre	Ottawa	Ontario	Canada	K1H 1C4
37	Peterborough Oncology Clinic	Peterborough	Ontario	Canada	K9H 7B6
38	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario	Canada	M4N 3M5
39	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4
40	Queen Elizabeth Hospital, PEI	Charlottetown	Prince Edward Island	Canada	C1A 8T5
41	Maisonneuve-Rosemont Hospital	Montreal	Quebec	Canada	H1T 2M4
42	McGill University	Montreal	Quebec	Canada	H2W 1S6
43	L'Hopital Laval	Ste-Foy	Quebec	Canada	G1V 4G5
44	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1