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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00513357
Recruitment Status : Completed
First Posted : August 8, 2007
Results First Posted : September 14, 2012
Last Update Posted : December 11, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Lung Cancer Drug: Melatonin Drug: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : June 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Melatonin
20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
Drug: Melatonin
20 mg by mouth daily for 4 Weeks

Placebo Comparator: Placebo
20 mg of Placebo before going to sleep at night for a period of 4 weeks.
Drug: Placebo
Capsule by mouth daily for 4 Weeks

Primary Outcome Measures :
  1. Change in Appetite as Measured by ESAS [ Time Frame: Baseline and at 4 weeks ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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)
  2. Greater than or equal to 18 years of age
  3. Karnofsky score of 40 or higher
  4. Patient has the ability to maintain oral food intake during the study period
  5. 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
  6. Ability to sign informed consent and understand study procedures
  7. 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
  8. Negative pregnancy testing in women with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
  9. Patients who cannot take Megace because of past history or elevated risk of DVT, adrenal insufficiency, impotence, hyperglycemia, CHF, menorrhagia, etc.
  10. Patients who have persistent anorexia/cachexia after treatment with Megace has failed

Exclusion Criteria:

  1. Patients who have dementia or delirium on entry into study as determined by the palliative care specialist using DSM-IV-criteria
  2. Patients who are currently taking melatonin
  3. Inability to take oral food during the study period
  4. 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.
  5. Inability to sign informed consent or understand study procedures
  6. Karnofsky score of < 40
  7. Patients < 18 years of age
  8. Patients with </= 5% involuntary weight loss within the last 6 months and anorexia of < 3 on ESAS
  9. Patients who are on complementary therapies containing melatonin or on medications for < 2 weeks and not on stable dose
  10. Patients who have a cortisol level of </= 4.3 mg/dL at baseline will be excluded, unless they are on replacement corticosteroids.
  11. Patients with a TSH of </= 0.50 or >/= 10 mcL/mL at baseline will be excluded
  12. Pregnant females or females who are lactating/nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00513357

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
Principal Investigator: Rony Dev, DO M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00513357     History of Changes
Other Study ID Numbers: 2005-0901
First Posted: August 8, 2007    Key Record Dates
Results First Posted: September 14, 2012
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by M.D. Anderson Cancer Center:
Gastrointestinal Cancer
Lung Cancer
Weight Loss

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants