Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients
Condition: Gastrointestinal Cancer; Lung Cancer
MeSH terms: Gastrointestinal Neoplasms
Intervention: Melatonin; Placebo
Intervention description: 20 mg by mouth daily for 4 Weeks; Capsule by mouth daily for 4 Weeks
Intervention MeSH terms: Melatonin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastrointestinal Cancer; Lung Cancer; Cachexia; Melatonin; Placebo; Anorexia; Weight Loss

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.
    

Eligibility 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