Omega-3 Fatty Acids With PD-1 Inhibitors in Advanced Esophageal Cancer
ConditionEsophageal Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
This is a randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate whether adding omega-3 fatty acids improves outcomes in adult patients with recurrent or metastatic esophageal cancer receiving PD-1 inhibitor therapy.
The main questions are:
Compared with placebo, does omega-3 (EPA+DHA) increase the longitudinal change in skeletal muscle index (ΔSMI) over 6 months? Does it improve clinical outcomes and favorably modulate immune and metabolic biomarkers as well as patient-reported outcomes ?
Participants will be randomized 1:1 to:
Intervention: Standard PD-1 therapy plus oral omega-3 (EPA 2.5 g + DHA 1.25 g per day) for 6 months.
Control: Standard PD-1 therapy plus matching placebo for 6 months. Participants will attend study visits at baseline, 3 months, and 6 months (then every 3 months up to 2 years), undergo body composition and functional assessments, blood sampling, and questionnaires, and have treatment adherence assessed per protocol. Pre-specified exploratory biomarker analyses will be conducted to support mechanism research.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
PD-1 + Omega-3 Fatty Acids (EPA/DHA)
Dietary supplementIntervention: Omega-3 (EPA 2.5 g + DHA 1.25 g/day) oral drops × 6 months; with PD-1; blinded; adherence via check-ins/bottle counts/plasma EPA/DHA.
PD-1 + Placebo (Oral Drops)
Dietary supplementComparator: Matching placebo oral drops × 6 months; with PD-1; blinded; adherence via check-ins/bottle counts.
Treatment groups
142 Participants
are divided into 2 treatment groupsGroup A: PD-1 + Omega-3 (EPA/DHA)Experimental treatment 1 intervention
Group B: PD-1 + PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Skeletal Muscle Index (ΔSMI) From Baseline to 6 Months
Time frame
From randomization to Month 6 (±4 weeks)Sponsors and contacts
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Source ClinicalTrials.gov