A Phase 2 interventional study of Biospecimen Collection and Oligo-fucoidan in Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm and Breast Carcinoma, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Prevention
Among 316 studies in Gastrointestinal Neoplasms with a site in United States — 83 open to participants now, 116 under way, 4 of them phase 3. Gastrointestinal Neoplasms · United States.
Among the 316 studies in Gastrointestinal Neoplasms with a site in United States, this one is the 160th largest by planned enrollment of the 245 interventional ones that give a count, is one of 21 that started in 2025, is one of 42 in phase 2, reaches primary completion later than 97 of the 113 other live ones, and was the 284th registered.
696 studies on the registry are indexed under Gastrointestinal Neoplasms; 210 are open to participants now.
Browse Gastrointestinal Neoplasms studies →83 of the 316 studies in Gastrointestinal Neoplasms with a site in United States are open now. Recruiting first, the newest first:
University of Arizona · Sites in United States
Ages 18–99
Orlando Health, Inc. · Sites in United States
Ages 18–100
Northwestern University · Sites in United States
Ages 18+
BigHat Biosciences, Inc. · Sites in United States
Ages 18+
Genmab · Sites in United States, Australia, Belgium and 8 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 160 Gastrointestinal Neoplasms studies recruiting now, 122 (76%) set no upper age limit and 18 (11%) stop at 75 or younger; 8 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
316 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 96 · Phase 2 82 · Phase 3 12 · Phase 4 4
First in 1995; this study’s year is marked. 21 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 34 is below the median of 74 across 495 interventional studies indexed under Gastrointestinal Neoplasms.
Median enrollment 60 across the 245 interventional studies, 165 across the 64 observational. Of the 182 that completed or were terminated, 68 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
86 of 316 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,270 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 5 studies filed under Gastrointestinal Neoplasms — fewer than ten, so there is no comparison to draw.
39 of the studies in Gastrointestinal Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06511037University of California, IrvinePhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis | 2026-11-30 |
| NCT05318027Abramson Cancer Center at Penn MedicineChatBot and Activity Monitoring in Patients Undergoing Chemoradiotherapy | 2026-12 |
| NCT06065371Henry Ford Health SystemSacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy | 2026-12 |
| NCT06569693University of MiamiDyadic Sleep Study | 2026-12-01 |
| NCT06134687Baylor College of MedicineNovel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection | 2026-12-04 |
Add all 39 to your calendar (.ics) → With an account.
Among the 316 studies in Gastrointestinal Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
The criteria were revised on the registry on Sep 25, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Biospecimen Collection · Dietary Supplement: Oligo-fucoidan · Other: Questionnaire Administration
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.
Procedure: Biospecimen Collection · Drug: Placebo Administration · Other: Questionnaire Administration
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Given PO
Also known as: Low-molecular-weight Fucoidan, Oligo Fucoidan
Given PO
Ancillary 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.
Time frame: Baseline to 8 weeks
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 16 weeks
Started Mar 2025 (actual). Primary completion is estimated for Jan 2029, 46 months after the start.
Of 55 phase 2 interventional studies under Gastrointestinal Neoplasms, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 73. This study's planned 46 months is close to that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: primary completion Feb 2027 → Jan 2029 and completion Feb 2027 → Jan 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Oligo-fucoidan