Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients

NCT00513357 | Completed Phase 3 Results DMC

• 1 other identifier: 2005-0901
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical research study is to evaluate the effectiveness of melatonin for the management of poor appetite and weight loss in advanced cancer patients. The effectiveness of melatonin on weight gain, keeping/gaining of lean muscle mass, improved appetite, and side effects will also be evaluated.

Conditions

Gastrointestinal Cancer; Lung Cancer

Keywords

Gastrointestinal Cancer; Lung Cancer; Cachexia; Melatonin; Placebo; Anorexia; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Change in Appetite as Measured by ESAS

  Difference in ESAS (Edmonton Symptom Assessment Scale) assessment scores of appetite (symptom) from baseline evaluation \[± 3 days\] to 4 week evaluation \[± 3 days\], where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity.

  Baseline and at 4 weeks

Study Arms (2)

Melatonin

EXPERIMENTAL

20 mg of Melatonin before going to sleep at night for a period of 4 weeks.

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

20 mg of Placebo before going to sleep at night for a period of 4 weeks.

Drug: Placebo

Interventions

Melatonin DRUG

20 mg by mouth daily for 4 Weeks

Melatonin

Placebo DRUG

Capsule by mouth daily for 4 Weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with solid gastrointestinal tumors or lung cancer patients referred to palliative care and a 5% or more involuntary weight loss within the last 6 months with anorexia (\>3 on visual analog scale such as ESAS)
• Greater than or equal to 18 years of age
• Karnofsky score of 40 or higher
• Patient has the ability to maintain oral food intake during the study period
• Ability to sign informed consent and understand study procedures
• Patient can continue all medications including complementary therapies or antineoplastic therapy while on-study other than melatonin if they have been on stable dose for at least 2 weeks
• Negative pregnancy testing in women with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
• Patients who cannot take Megace because of past history or elevated risk of DVT, adrenal insufficiency, impotence, hyperglycemia, CHF, menorrhagia, etc.
• Patients who have persistent anorexia/cachexia after treatment with Megace has failed

You may not qualify if:

• Patients who have dementia or delirium on entry into study as determined by the palliative care specialist using DSM-IV-criteria
• Patients who are currently taking melatonin
• Inability to take oral food during the study period
• Inability to sign informed consent or understand study procedures
• Karnofsky score of \< 40
• Patients \< 18 years of age
• Patients with \</= 5% involuntary weight loss within the last 6 months and anorexia of \< 3 on ESAS
• Patients who are on complementary therapies containing melatonin or on medications for \< 2 weeks and not on stable dose
• Patients who have a cortisol level of \</= 4.3 mg/dL at baseline will be excluded, unless they are on replacement corticosteroids.
• Patients with a TSH of \</= 0.50 or \>/= 10 mcL/mL at baseline will be excluded
• Pregnant females or females who are lactating/nursing

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (2)

Joan Karnell Cancer Center

Philadelphia, Pennsylvania, 19107, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Del Fabbro E, Dev R, Hui D, Palmer L, Bruera E. Effects of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: a double-blind placebo-controlled trial. J Clin Oncol. 2013 Apr 1;31(10):1271-6. doi: 10.1200/JCO.2012.43.6766. Epub 2013 Feb 25.

  PMID: 23439759 DERIVED

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Lung Neoplasms; Cachexia; Anorexia; Weight Loss

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Egidio Del Fabbro
• Organization: University of Texas MD Anderson Cancer Center

ammarin@mdanderson.org

713-563-4157

Study Officials

• Rony Dev, DO

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: June 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 11, 2012
• Results First Posted: September 14, 2012

Record last verified: 2012-12

Locations

US (2)