Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality (AMPLCaRe)

The Canadian College of Naturopathic Medicine

Status and phase: Completed; Phase 3

Conditions: Non Small Cell Lung Cancer

Treatments: Dietary Supplement: placebo; Dietary Supplement: melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT00668707

2007077-01H

Details and patient eligibility

About

There is evidence to support the use of melatonin, a natural health product, as an additional treatment aid for cancer patients. This study is designed to see if the daily ingestion of 20 milligrams of melatonin for one year can lower the incidence of developing lung cancer recurrence and/or death. Only patients with a diagnosis of non small cell lung cancer who are eligible for surgical resection can participate in the trial. The study will also be assessing for changes in quality of life, pain, fatigue, anxiety, sleep, and depression amongst the participants.

Full description

The trial employs a two-armed parallel placebo controlled trial design whereby patients with a diagnosis of non small cell lung cancer are randomized to receive either 20 mg of melatonin nightly or an identically matched placebo. All patients will be followed for two years with primary outcomes assessed at a two year time point and secondary outcomes evaluated throughout the course of the trial.

Enrollment: 709 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of non small cell lung cancer
• Eligible for surgical resection
• Willingness to adhere to randomized treatment
• Availability for follow-up schedule of visits

Exclusion criteria

• Taking exogenous melatonin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

709 participants in 2 patient groups, including a placebo group

Melatonin

Experimental group

Description:

To receive 20 mg of melatonin nightly for 1 year post-surgery

Treatment:

Dietary Supplement: melatonin

Placebo

Placebo Comparator group

Description:

To receive 20 mg placebo nightly for 1 year post-surgery

Treatment:

Dietary Supplement: placebo