Malignant Digestive System NeoplasmPhase 2NCT06855524
Fucoidan for Preventing Chemotherapy-Related Fatigue in Patients With Gastrointestinal, Gynecological, Breast, or Lung Cancer
A Phase 2 study testing Biospecimen Collection, Oligo-fucoidan and Questionnaire Administration in people with Malignant Digestive System Neoplasm and Malignant Female Reproductive System Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm, Breast Carcinoma
- What is being tested?
- Biospecimen Collection, Oligo-fucoidan and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2025to 28 Jan 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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 Cockcroft-Gault (obtained ≤ 30 days prior to registration)
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- Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 1.5 x UNL; [≤ 5 x upper limit of normal (ULN) for patients with liver involvement] (obtained ≤ 30 days prior to registration)
- Ability to complete patient questionnaires alone or with assistance and to be willing to be contacted by study staff
- Provide written informed consent
- Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Willing to use a highly effective method of contraception from the first dose of study medication through 30 days after the last dose of study medication, for persons of childbearing potential or persons able to father a child only
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
Who cannot join
- 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
- Malnutrition, active infection, severe depression, significant pulmonary disease, and/or cardiovascular disease that the attending physician feels could be causing the patient's fatigue
- Use of any over-the-counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing ginseng, rhodiola rosea, guarana, or anything called an "adaptogen"), including current use of fucoidan
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- Current use of warfarin, heparin, enoxaparin, or a novel anticoagulant or known bleeding disorder/abnormal prothrombin time (PT)/partial thromboplastin time (PTT) at baseline
- Current use of bevacizumab
- Untreated thyroid conditions
- Use of chemotherapy and/or immunotherapy ≤ 90 days prior to registration
- Unwillingness to follow study related procedures
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Zoey I. Harris, MD
About this study
Official title: MC231007 Fucoidan For Patients With Chemotherapy-Related Fatigue: A Double-Blind, Randomized, Placebo-Controlled Pilot Study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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, Breast Carcinoma, Lung Carcinoma, Malignant Solid Neoplasm
- Being tested
- Biospecimen Collection, Oligo-fucoidan, Placebo Administration, Questionnaire Administration
- Medical subject headings
- Gastrointestinal Neoplasms, Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Oligo-fucoidanDietary supplement
Also called Low-molecular-weight Fucoidan, Oligo Fucoidan
Given PO
Placebo AdministrationDrug
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (fucoidan) | Experimental | Patients receive fucoidan PO 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. Receives: Procedure: Biospecimen Collection; Dietary Supplement: Oligo-fucoidan; Other: Questionnaire Administration |
| Arm 2 (placebo) | Placebo comparator | 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. Receives: Procedure: Biospecimen Collection; Drug: Placebo Administration; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks
Secondary outcomes (4)
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.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
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).
Measured: Week 8 and Week 16
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.
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start6 Mar 2025
- Primary completion28 Jan 2029 (estimated)
- Study completion28 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Digestive System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zoey I. Harris, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855524
- Sponsor's protocol ID
- MC231007
- Other IDs
- NCI-2025-01334, 24-004592
- Status last verified
- Oct 2026
- First submitted
- 26 Feb 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No