Advanced Stage Cancer
Conditions
Keywords
cancer, melatonin, adjuvant therapy, quality of life, survival, adverse events, oxidative stress
Brief summary
Meta-analysis of previous studies have shown that melatonin is a beneficial adjutant for reducing chemotherapy-induced toxicity; however no randomized, double-blind, placebo controlled trials have been conducted. This study evaluates the effect of melatonin in improving quality of life and reducing chemotherapy-induced toxicity in advanced cancer patients. This is a multi-center, randomized, double-blind, placebo controlled trial conducted in patients with histologically proven advanced non small cell lung, breast, head and neck or sarcoma cancer. Mixed-block randomization, stratified by center and treatment scheme is used to divide eligible patients into three groups: melatonin 20 mg, 10 mg or matched placebo. The patients are required to take the studied drugs at night (after 21.00 pm) on the first day of chemotherapy and continue daily for six months. Standard treatment is chemotherapy according to each center's standard protocol. Study endpoints are QOL (FACT), adverse event frequency (CTCAE), oxidative stress status, melatonin level, and survival.
Interventions
DRUG10 mg Melatonin
Active Comparator: Drug: Melatonin 10 mg
DRUG20 mg Melatonin
Active Comparator: Drug: Melatonin 20 mg
DRUGMatched placebo
Matched placebo (identical formulation and delivery, without active ingredient)
Sponsors
Srinagarind Hospital, Khon Kaen University
Khon Kaen Hospital, Khon Kaen
General Drugs House Co.,LTD.
Thailand Research Fund
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* histologically proven advanced NSCLC, breast, head and neck, sarcoma cancer Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 * platelet count ≥100,000 cells/mm3 * white blood cell count ≥ 3,000 cell/mm3 * hemoglobin ≥ 10 g/dL * serum creatinine ≤ 1.5 mg/dL * bilirubin ≤ 2 mg/dL * AST ≤ 2.5 times upper limit of normal(ULN)for subjects without metastases or AST ≤ 2.5 times UNL for those with liver metastases * New York Heart Association grade ≤ 2 * written consent
Exclusion criteria
* Patients who receive prior chemotherapy or biotherapy, radiotherapy or surgery within 1 month preceding randomization * Patients who have more than one type of cancer or brain metastasis were excluded from the trial. * Patients with moderate neuropathy (CTCAE grade ≥ 2) * Patients with an active infection, or uncontrolled complications (i.e. blood glucose \> 200 mg/dL, uncontrolled hypertension, unstable angina, history of congestive heart failure or history of myocardial infarction within one year).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (FACT) | Change from baseline in total scores at 6 months after treatment | Self-reported questionnaires. FACT-L, FACT-B, FACT-H&N and FACT-G Thai Version 4 has been previously validated. FACT-L, FACT-B, FACT-H&N and FACT-G are used in lung, breast, head&neck and sarcoma cancer patients, respectively. Change from baseline will be evaluated at 1,2,3 and 6 months after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | Baseline and 1,2,3 and 6 months after treatment | CTCAE Version 4.3 |
| Oxidative stress status | Chemotherapy cycles 1,2,3,4 | 8-isoprostane and 8-hydroxydeoxyguanosine urine and MDA plasma analysis |
| Melatonin level | Chemotherapy cycle 1,2,3 and 4 | Blood, urine and saliva analysis |
| Overall survival | Over 4 years of the study | Overall survival |
Countries
Thailand
Outcome results
None listed