Study of Fucoidan to Prevent Fatigue in Adults Undergoing Chemotherapy for Gastrointestinal or Gynecological Cancer

What this Trial Is About

Researchers are evaluating fucoidan, a dietary supplement made from brown seaweed, to see if it can prevent fatigue caused by chemotherapy in patients with gastrointestinal or gynecological cancers. Fatigue is a common and challenging side effect for patients undergoing systemic chemotherapy. This phase 2, double-blind, randomized, placebo-controlled pilot study aims to compare fucoidan to a placebo in reducing chemotherapy-related fatigue and its effects on inflammatory markers. Participants are randomly assigned to one of two groups. One group receives fucoidan orally three times a day for 8 weeks, then switches to placebo for the next 8 weeks. The other group starts with placebo three times a day for 8 weeks, then crosses over to fucoidan for 8 weeks. Blood samples may be collected during screening and throughout the study to assess inflammatory markers and other biological factors. Participants will be assessed on their fatigue levels using a simple fatigue measure at the start, 8 weeks, and 16 weeks. Additional assessments include symptom diaries, global impression of change, and the Functional Assessment of Cancer Therapy-Fatigue subscale. Safety and side effects are monitored through patient-reported symptom diaries. The total participation covers 16 weeks of treatment with follow-up evaluations during this time.

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