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

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.