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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00513357
First received: August 6, 2007
Last updated: December 7, 2012
Last verified: December 2012
  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 3

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:


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

Primary Outcome Measures:
  • Change in Appetite as Measured by ESAS [ Time Frame: Baseline and at 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 82
Study Start Date: June 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Rony Dev, DO M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: June 6, 2012
Last Updated: December 7, 2012
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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014