Fucoidan for Patients With Chemotherapy-Related Fatigue: A Double-Blind, Randomized, Placebo-Controlled Pilot Study
Mayo Clinic
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.
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 Sympt…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1 * Starting platinum-based doublet/triplet therapy for gynecologic or gastrointestinal cancer in the non-curative setting, with at least 16 weeks of chemotherapy and/or immunotherapy planned prior to registration; able to start study treatment ≤ 7 days prior to starting chemotherapy * Life expectancy at least 6 months * Hemoglobin ≥ 10 g/dL (obtained ≤ 30 days prior to registration) * Creatinine ≤ 1.5 x upper normal limit (UNL) OR calculated creatinine clearance ≥ 50 ml/min using the Cockc…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- Dietary SupplementOligo-fucoidan
Given PO
- DrugPlacebo Administration
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Location
- Mayo Clinic in ArizonaScottsdale, Arizona