Effect of Melatonin on autologous hematopoietic stem cells transplant success

Evaluation of the effect of Melatonin on the stem cells collection and engraftment in autologous hematopoietic stem cells transplant recipients

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100127003210N20

Enrollment

Registered

2020-02-20

Start date

2019-11-05

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autologous Hematopoietic Stem Cells Transplant.

Interventions

Intervention 1: In the intervention group, patients receive Melatonin (manufactured by Vana Daru Gostar) along with the G-CSF protocol. The administration of sublingual Melatonin starts 5 days prior t

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Diagnosis of malignancy according to expert opinion and Laboratory data Fill in the Consent Ages 18-70 years

Exclusion criteria

Exclusion criteria: Not using of Melatonin for 3 doses consecutive Inability to use sublingual tablets Taking more than 2 sedative or hypnotic medicine (example: Benzodiazepines) regulary over a week

Design outcomes

Primary

Measure	Time frame
CD34 changes. Timepoint: Daily. Method of measurement: Blood sample and use a Laboratory Kit.;Engraftment duration. Timepoint: Daily. Method of measurement: Blood sample.;GCSF dose requirement. Timepoint: Daily. Method of measurement: Dose requirement according physician orders.	—

Secondary

Measure	Time frame
Sleep disturbance during transplant. Timepoint: Weekly. Method of measurement: Insomnia Severity Index (ISI).;Anxiety score during transplantation. Timepoint: Weekly. Method of measurement: Hospital Anxiety and Depression Scale (HADS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaria Tavakoli Ardakani

Shahid Beheshti University of Medical Sciences

Mariatavakoli@sbmu.ac.ir+98 21 8820 0085

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026