NCT06855524

Fucoidan for Preventing Chemotherapy-Related Fatigue in Patients With Gastrointestinal or Gynecological Cancer

Fucoidan for Patients With Chemotherapy-Related Fatigue: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial tests how well fucoidan works in preventing chemotherapy-related fatigue compared to a placebo in patients with gastrointestinal (GI) or gynecological (GYN) cancer. Fatigue poses a burden in patients with malignancies undergoing systemic chemotherapy. Fucoidan is a dietary supplement made of complex sugar that contain sulfate groups attached to their sugar units (sulfated polysaccharide) which found in brown seaweed. It is thought to have anti-inflammatory, anti-viral, anti-thrombotic, anti-diabetic, and anti-tumor effects in pre-clinical models. Giving fucoidan may be effective in preventing chemotherapy-related fatigue in patients with GI or GYN.

Detailed description

PRIMARY OBJECTIVE: I. To determine the efficacy of fucoidan versus (vs.) placebo in preventing fatigue as assessed by a single-item measure of fatigue at 8 weeks following the initiation of platinum-based doublet/triplet. SECONDARY OBJECTIVES: I. To estimate 1) changes in fatigue via the single item measure of fatigue from baseline to week 16 2) the Global Impression of Change at week 8 and week 16 and 3) the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) subscale at week 8 and week 16. II. To evaluate the frequency and severity of toxicity as reported by the patient on the Symptom Experience Diary. EXPLORATORY OBJECTIVE: I. To evaluate if there are differences in inflammatory markers C-reactive protein (CRP) and IL-6 between groups from baseline to week 8. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive fucoidan orally (PO) three times a day (TID) for 8 weeks. After completion of fucoidan, patients then cross over into Arm 2 for 8 weeks. Patients may optionally undergo blood sample collection during screening and on study. ARM 2: Patients receive placebo PO TID for 8 weeks. After completion of placebo, patients then cross over into Arm 1 for 8 weeks. Patients may optionally undergo blood sample collection during screening and on study.

Conditions

• Malignant Digestive System Neoplasm
• Malignant Female Reproductive System Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
DIETARY_SUPPLEMENT	Oligo-fucoidan	Given PO
DRUG	Placebo Administration	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2025-03-06
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2025-03-04
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study