Effect of Melatonin on arthralgia-myalgia of Paclitaxel

The effect of melatonin on incidence and severity of arthralgia-myalgia caused by weekly paclitaxel in patients with breast cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190630044057N1

Enrollment

Registered

2019-09-28

Start date

2019-09-23

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Breast cancer. Malignant neoplasm of breast

Interventions

Intervention 1: Intervention group: Melatonin with dose of 10 mg from Best naturals company will be prescribed every night from the day Paclitaxel administration to one week period for 12 weeks. Inter

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Women with Breast Cancer and Candidate receiving Paclitaxel 80 mg / m 2 weekly for 12 weeks after doxorubicin + cyclophosphamide regimen Age over 18 years Ability to take oral medication Ability to fill out a questionnaire Not taking pain relief medication for chronic No peripheral neuropathy No history of fibromyalgia, Rheumatoid arthritis, Osteoarthritis No history of receiving paclitaxel or any other drug with neurotoxicity Uncontrolled diabetes no history of receiving alcohol, statin, colchicine, zidovudine, penicillamine. no history of metastatic disease

Exclusion criteria

Exclusion criteria: Patients with concurrent GCSF administration Patients who experience trauma or falling during the study Viral Respiratory Infection During Study

Design outcomes

Primary

Measure	Time frame
Arthralgia. Timepoint: Arthralgia before Paclitaxel administration and daily after. Method of measurement: Brief Pain Inventory (BPI) and National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE).;Myalgia. Timepoint: Myalgia before Paclitaxel administration and daily after. Method of measurement: Brief Pain Inventory (BPI) and National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE).;Neuropathy. Timepoint: neuropathy before Paclitaxel administration and weekly after. Method of measurement: Douleur Neuropathique 4 Questions (DN4) and National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE).	—

Measure

Time frame

Arthralgia. Timepoint: Arthralgia before Paclitaxel administration and daily after. Method of measurement: Brief Pain Inventory (BPI) and National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE).;Myalgia. Timepoint: Myalgia before Paclitaxel administration and daily after. Method of measurement: Brief Pain Inventory (BPI) and National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE).;Neuropathy. Timepoint: neuropathy before Paclitaxel administration and weekly after. Method of measurement: Douleur Neuropathique 4 Questions (DN4) and National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Jahangard-Rafsanjani

Tehran University of Medical Sciences

zjahangard@sina.tums.ac.ir+98 21 6658 1692

Outcome results

None listed

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