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Omega-3 fatty acids and chemotherapy-induced neurotoxicity in colon cancer

The effects of omega-3 fatty acids on oxaliplatin-induced neuropathy and inflammation in patients with colon cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201112158397N2
Enrollment
60
Registered
2011-12-24
Start date
2012-02-02
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Colon cancer. Malignant neoplasm of colon

Interventions

Intervention 1: Intervention: Eligible recruited patients with colorectal cancer who randomly assigned to be in the intervention arm, received 640 mg oil fish pearls (54% DHA and 10% EPA)3 times a day
Treatment - Drugs
Intervention: Eligible recruited patients with colorectal cancer who randomly assigned to be in the intervention arm, received 640 mg oil fish pearls (54% DHA and 10% EPA)3 times a day for 6 months d
Control: Eligible recruited patients with colorectal cancer who randomly assigned to be in the control arm received placebo pearls 3 times a day for 6 months(during chemotherapy with oxaliplatin)

Sponsors

Liver and Gastrointestinal Diseases Research Center,Tabriz University of Medical Sciences
Lead Sponsor
Added at 2014-08-27:SANOFI IRAN
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion criterion: Patients with colorectal cancer (high risk stage 2, stage 3 & 4) candidate to receive oxaliplatin. Exclusion criteria: Suffering from the diseases associated with neuropathy (e.g.diabetes, and primary neural diseases); any previous chemotherapy and receiving any forms of supplementation (fish oil, vitamins &minerals) since 3 months before enrollment

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Incidence and severity of oxaliplatin-induced peripheral nauropathy. Timepoint: before chemotherapy with oxaliplatin and one month after the end of the treatment. Method of measurement: Reduced total neuropathy score(rTNS) and Electrophysiological evaluation.;Serum concentration of interleukin-1 beta. Timepoint: before chemotherapy with oxaliplatin and one month after the end of the treatment. Method of measurement: ELISA.;Serum concentration of interleukin-6. Timepoint: before chemotherapy with oxaliplatin and one month after the end of the treatment. Method of measurement: ELISA.;Serum concentration of TNF-alpha. Timepoint: before chemotherapy with oxaliplatin and one month after the end of the treatment. Method of measurement: ELISA.;Serum concentration of Highly sensitive-CRP. Timepoint: before chemotherapy with oxaliplatin and one month after the end of the treatment. Method of measurement: Nephlometry.

Secondary

MeasureTime frame
Concentrations of omega-3 fatty acids in the serum phospholipids. Timepoint: before chemotherapy with oxaliplatin and one month after the end of the treatment. Method of measurement: Gas chromatography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Esfahani

Tabriz University of Medical Sciences

esfahania@tbzmed.ac.ir+98 41 1334 3811

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 13, 2026