Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00513357

Purpose

Primary objective: To determine if Melatonin will improve appetite in advanced cancer pts. with anorexia/cachexia as defined by an improvement of 1.5 in appetite score from baseline on the ESAS

Secondary objective-A: To determine if Melatonin will improve weight gain, and preserve/gain lean muscle mass in advanced cancer pts. with anorexia/cachexia

Secondary objective-B: To determine if Melatonin will improve pain, well-being, nausea, and depression as measured by the ESAS and FACIT-F in advanced cancer pts. with anorexia/cachexia

Condition	Intervention	Phase
Gastrointestinal Cancer Lung Cancer	Drug: Melatonin Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Clinical Trial of Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Melatonin

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Change in Appetite as Measured by ESAS (Edmonton Symptom Assessment Scale) [ Time Frame: Evaluated at baseline [± 3 days], 2 weeks [± 3 days] and 4 weeks [± 3 days] ] [ Designated as safety issue: No ]

Estimated Enrollment:	126
Study Start Date:	June 2006
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Melatonin: Experimental	Drug: Melatonin 20 mg by mouth daily for 4 Weeks
Placebo: Placebo Comparator	Drug: Placebo Capsule by mouth daily for 4 Weeks

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Eligibility

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

Criteria

Inclusion Criteria:

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
Patients who have persistent anorexia/cachexia and are currently taking a stable dose of Megace, corticosteroids, non-steroidal anti-inflammatories (NSAID'S), or thalidomide and started at least 2 weeks prior to study inclusion
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.

Exclusion Criteria:

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
Unstable secondary cachexia caused by nausea, diarrhea, taste abnormalities, mucositis, constipation, dysphagia, or clinical depression prior to study inclusion. These symptoms should be resolved or stable for >/= 2 weeks at the time of inclusion into study as determined by the Palliative Care Specialist.
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.
Patients with a TSH of </= 0.50 or >/= 5.50 mcL/mL at baseline will be excluded
Pregnant females or females who are lactating/nursing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513357

Contacts

Contact: Egidio Del Fabbro, MD

713-792-6085

Locations

United States, Pennsylvania
Joan Karnell Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Egidio Del Fabbro, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Egidio Del Fabbro, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Egidio Del Fabbro, MD/Assistant Professor )
Study ID Numbers:	2005-0901
Study First Received:	August 6, 2007
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00513357 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Gastrointestinal Cancer
Lung Cancer
Cachexia
Melatonin

Placebo
Anorexia
Weight Loss

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Antioxidants
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Protective Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Digestive System Diseases
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Gastrointestinal Neoplasms
Melatonin
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010