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

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00513357

Purpose

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.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 Weight Control

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 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Melatonin	Drug: Melatonin 20 mg by mouth daily for 4 Weeks
Placebo Comparator: Placebo	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
If patients who have persistent anorexia/cachexia and are currently taking Megace, corticosteroids, non-steroidal anti-inflammatories (NSAID's), or thalidomide, they should be on the medication 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, 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

Contacts and Locations

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

Locations

United States, Pennsylvania
Joan Karnell Cancer Center
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Egidio Del Fabbro, MD

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:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00513357 History of Changes
Other Study ID Numbers:	2005-0901
Study First Received:	August 6, 2007
Last Updated:	September 22, 2011
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:

Lung Neoplasms
Gastrointestinal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Digestive System Diseases

Gastrointestinal Diseases
Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012