Summary
Melatonin has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Cancer. ClinicalTrials.gov lists 8 registered trials linking Melatonin to Cancer: 1 is active or not yet recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT02506790). It plans or enrolled 96 participants. Registration activity spans 2006 to 2022. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 3 systematic reviews and 5 clinical trial publications. Publication years run from 2024 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Cancer ranks 1226 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous regression is rare (<0.5% of cases); 5-year survival without treatment: <5% for advanced NSCLC; ~20% for stage I-II with surgery.
Evidence table
| Evidence tier | C · Preliminary |
|---|---|
| Evidence score | 53.0 (trials 18.0, literature 30.0, tier 5, approved bonus 0.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 4 completed, 3 other |
| Linked publications | 15 (5 Cochrane reviews, 5 clinical trial publications, 3 systematic reviews, 2 meta-analyses) |
| Agent type | Supplement |
| Development stage (any indication) | Preclinical |
| Mechanism / class | Cancer metabolism as a therapeutic target and review of interventions · Halma M, Tuszynski JA · 2023 |
| Data sources | OSMF Chronic Disease Review |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01628029 | Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer 2014 | active, not recruiting | Phase 2 | 68 |
| NCT02506790 | Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer 2015 | status unknown | Phase 2 | 96 |
| NCT01805089 | Melatonin Versus Placebo in Breast Cancer 2006 | completed | Early Phase 1 | 95 |
| NCT06125353 | The Effect of Melatonin Supplementation on Fatigue Symptoms During Chemotherapy Treatment of Breast Cancer Patients 2022 | completed | Not applicable | 56 |
| NCT00925899 | Melatonin for Fatigue and Other Symptoms in Patients With Advanced Cancer 2009 | completed | PHASE2, PHASE3 | 72 |
| NCT00876499 | Fatigue, Sleep and Cytokines in Primary Brain Tumor (PBT) Patients 2009 | completed | Not applicable | 20 |
| NCT00625742 | Multimodal Treatment Strategy for Cancer Cachexia 2008 | terminated | Not applicable | 15 |
| NCT04251845 | Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia 2020 | status unknown | Not applicable | 66 |
Published literature
- Clinical trial publication Efficacy of an exercise oncology program on sleep quality and circadian rhythm in head and neck cancer patients undergoing chemo-radiation therapy: a randomized controlled trialDsilva C, Shetty VJ, Fernandes D et al. · PeerJ · 2026 · PMID 42371549
- Clinical trial publication Adjunctive melatonin and sildenafil, enhances antioxidant defense in metformin-treated polycystic ovary syndrome patients: A randomized studyHosseinabad MF, Masnavi E, Eslamnik PA et al. · Journal of gynecology obstetrics and human reproduction · 2026 · PMID 41881108
- Clinical trial publication Restoring circadian homeostasis is associated with immune-metabolic recovery and medium-term oncologic outcomes after rectal cancer surgery: a prospective randomized trialPan S, Wang G · Surgical endoscopy · 2026 · PMID 41840084
- Clinical trial publication Targeting Side Effects Associated with Androgen Deprivation Therapy Using Melatonin: A Randomized Trial on Hot Flashes and Sexual Health in Prostate Cancer PatientsHosseini AK, Etedali A, Darakhshandeh A et al. · Asian Pacific journal of cancer prevention : APJCP · 2026 · PMID 41660902
- Cochrane review Melatonin in glioblastoma therapy: clinical promise and mechanistic insights from bench to bedsideAlomari O, Güney B, Juhmani RA et al. · Neurosurgical review · 2026 · PMID 41604009
- Systematic review Impact of Nutritional Supplements and Antioxidants in the Treatment of Breast Cancer: A Systematic ReviewUribe-Ramírez D, Laguna-Maldonado KD, Vázquez-Carrada M et al. · Nutrients · 2026 · PMID 42123930
- Systematic review The Efficacy and Safety of Nutritional Supplements for Cancer Supportive Care: An Umbrella Review and Hierarchical Evidence SynthesisBenna-Doyle S, Grant S, Maunder A et al. · Integrative cancer therapies · 2026 · PMID 41482855
- Clinical trial publication Melatonin supplementation for quality of life in older patients with advanced cancer: a randomized controlled trialGinzac A, Bourbouloux E, Rivoirard R et al. · BMC geriatrics · 2025 · PMID 41421991
- Cochrane review Pharmacological interventions for sleep disturbance ("insomnia") in patients with advanced cancer receiving specialist palliative care: a scoping reviewRyan S, Munir S, Davies A · Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025 · PMID 41284034
- Cochrane review Melatonin in cancer treatmentYu ZY, Peng RY, Cheng N et al. · The Cochrane database of systematic reviews · 2025 · PMID 40304216
- Cochrane review Influence of melatonin supplementation on cancer-related fatigue: a meta-analysis of randomized controlled trialsLi Y, Zhang W, Zeng X et al. · Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025 · PMID 39733381
- Meta-analysis Exploring the potential association and experimental validation of disrupted circadian rhythms with polycystic ovary syndrome via meta-analysis and bioinformatics: a possible pathogenic mechanismLi W, Zhang G, Fang Y et al. · Frontiers in endocrinology · 2025 · PMID 40475989
- Systematic review Impact of Dietary Supplements on Clinical Outcomes and Quality of Life in Patients with Breast Cancer: A Systematic ReviewScafuri L, Buonerba C, Strianese O et al. · Nutrients · 2025 · PMID 40290044
- Cochrane review Effect of melatonin supplementation on cardiometabolic risk factors, oxidative stress and hormonal profile in PCOS patients: a systematic review and meta-analysis of randomized clinical trialsZiaei S, Hasani M, Malekahmadi M et al. · Journal of ovarian research · 2024 · PMID 38965577
- Meta-analysis Interventions for insomnia in cancer patients and survivors-a comprehensive systematic review and meta-analysisNissen ER, Neumann H, Knutzen SM et al. · JNCI cancer spectrum · 2024 · PMID 38781520
Mechanism and notes
Recorded mechanism or class: Cancer metabolism as a therapeutic target and review of interventions · Halma M, Tuszynski JA · 2023.
OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Melatonin approved for Cancer?
Melatonin has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Melatonin in clinical trials for Cancer?
ClinicalTrials.gov lists 8 registered trials linking Melatonin to Cancer: 1 is active or not yet recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT02506790). It plans or enrolled 96 participants. Registration activity spans 2006 to 2022.
What does the evidence show for Melatonin in Cancer?
Melatonin has both completed registered trials and synthesis-level publications linked to Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.