This phase II trial tests how well fucoidan works in preventing chemotherapy-related fatigue compared to a placebo in patients with gastrointestinal (GI), gynecological (GYN), breast, or lung 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, GYN, breast, or lung cancer.
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
Starting platinum-based doublet/triplet therapy for gynecologic, gastrointestinal, breast, or lung 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
Known hypersensitivity to fucoidan or seaweed products
Currently using any other pharmacologic agents to specifically treat fatigue including psychostimulants or antidepressants. Note: Antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for ≥ 1 month prior to registration and plans to continue such for 8 weeks. Exercise is allowed
Psychiatric disorder such as untreated/uncontrolled depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia (defined per medical history)
Surgery that required general anesthetic ≤ 4 weeks prior to registration
Crossover
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Oligo-fucoidan
Dietary supplementGiven PO
Placebo Administration
DrugGiven PO
Questionnaire Administration
Other interventionAncillary studies
Change in fatigue, weeks 1-8
Will be assessed using self-reported fatigue over the past week. Fatigue is rated on a scale of 0-10 where 0=no fatigue at all and 10=fatigue as bad as it can be. Fatigue scores will be compared between arms.
Change in fatigue, weeks 9-16
Will be assessed using self-reported fatigue over the past week. Fatigue is rated on a scale of 0-10 where 0=no fatigue at all and 10=fatigue as bad as it can be. Fatigue scores will be compared between arms.
Change in the symptoms
Will be measured using the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scores, a 13-item questionnaire assessing fatigue symptoms over the past week. Responses to each item are scored on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Scores will be compared between arms.
Change in Subjective Global Impression of Change scores
Will be measured using the Subjective Global Impression of Change instrument, which consists of 3 items assessed since beginning study medication: fatigue, emotional state, and overall quality of life. Items are scored on a 7-poin scale ranging from -3 (very much worse) to 3 (very much better). Two additional questions are answered only at the end of week 8: which medication the respondent believes they were on (2 choices) and whether they were satisfied with the effect of treatment on fatigue (yes/no).
Incidence of rates of symptoms
Symptoms will be reported by the patient using the Symptom Experience Diary, which consists of 7 items assessing specific symptoms over the past week. Items are answered on a scale of 0 (none at all) to 10 (as bad as it can be). There is also one yes/no question related to exercise and one question for any side effects not addressed in the initial 7 items. Responses will be compared between arms.
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