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AnorexiaPhase 3NCT00031707

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

A Phase 3 study testing eicosapentaenoic acid and megestrol acetate in people with Anorexia and Cachexia, run by Alliance for Clinical Trials in Oncology at 44 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anorexia, Cachexia
What is being tested?
eicosapentaenoic acid and megestrol acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
429 participants
Where
44 sitesin 2 countries
Study dates
Mar 2000to Jan 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

44 sites in 2 countries.

44 sites in 2 countries

United States22 sites

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • Medcenter One Health System

    Bismarck, North Dakota, 58501

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • Altru Health Systems

    Grand Forks, North Dakota, 58201

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212-4772

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57709

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CentraCare Health Plaza

    Saint Cloud, Minnesota, 56303

  • CCOP - Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • Siouxland Hematology-Oncology

    Sioux City, Iowa, 51101-1733

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57104

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

Other trials in United States

Canada22 sites

  • William Osler Health Centre

    Brampton, Ontario, L6W 2Z8

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Queen Elizabeth Hospital, PEI

    Charlottetown, Prince Edward Island, C1A 8T5

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Trillium Health Centre

    Mississauga, Ontario, L5B 1B8

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Nanaimo Cancer Clinic

    Nanaimo, British Columbia, V9S 2B7

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Peterborough Oncology Clinic

    Peterborough, Ontario, K9H 7B6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • L'Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Anorexia, Cachexia
Being tested
eicosapentaenoic acid, megestrol acetate, placebo
Keywords
anorexia, cachexia
Medical subject headings
Anorexia, Cachexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eicosapentaenoic acidDietary supplement

  • megestrol acetateDrug

  • placeboOther

Study groups in NCT00031707
Study groupRoleWhat they receive
megestrol + placeboActive comparatorPatients 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.
Receives: Drug: megestrol acetate; Other: placebo
eicosapentaenoic acid + placeboActive comparatorPatients 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.
Receives: Dietary Supplement: eicosapentaenoic acid; Other: placebo
megestrol + eicosapentaenoic acidExperimentalPatients 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.
Receives: Dietary Supplement: eicosapentaenoic acid; Drug: megestrol acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the appetite-stimulating properties (eg, patient weight, rate of weight change, and appetite)

    Measured: Up to 5 years

Secondary outcomes (2)

  1. Assess quality of life

    Measured: Up to 5 years

  2. Overall survival

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2003 (estimated)
  2. Study startMar 2000
  3. Primary completionJan 2004
  4. Study completionJan 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
429 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00031707
Sponsor's protocol ID
NCCTG-989255
Other IDs
CDR0000069218, CAN-NCIC-SC18, NCI-P02-0205
Status last verified
Jul 2016
First submitted
8 Mar 2002
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Jatoi A, Rowland K, Loprinzi CL, Sloan JA, Dakhil SR, MacDonald N, Gagnon B, Novotny PJ, Mailliard JA, Bushey TI, Nair S, Christensen B; North Central Cancer Treatment Group. An eicosapentaenoic acid supplement versus megestrol acetate versus both for patients with cancer-associated wasting: a North Central Cancer Treatment Group and National Cancer Institute of Canada collaborative effort. J Clin Oncol. 2004 Jun 15;22(12):2469-76. doi: 10.1200/JCO.2004.06.024.

    PubMed 15197210

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing eicosapentaenoic acid and megestrol acetate in people with Anorexia and Cachexia, run by Alliance for Clinical Trials in Oncology at 44 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the appetite-stimulating properties (eg, patient weight, rate of weight change, and appetite) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00031707, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.

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