FatiguePhase 2NCT06295588
Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer
A Phase 2 study testing Fucoidan extracted from F. Vesiculosus and Fucoidan extracted from U. Pinnatifida in people with Fatigue and Inflammation, run by University of Rochester at 1 site in United States.
Trial summary
To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, Inflammation
- What is being tested?
- Fucoidan extracted from F. Vesiculosus and Fucoidan extracted from U. Pinnatifida
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2025to 1 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Survivors of cancer
- Age 18 or older
- Speak and understand English
- Have completed surgery, radiation, and/or systemic intravenous anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) ≤10 years prior to enrollment.
- Have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
- Be willing to commit to the fucoidan supplement dosing and delivery method, to complete evaluation instruments, and to attend all study visits.
- Completed Informed Consent
Who cannot join
- Current warfarin or other anti-coagulation medication use.
- Current use of supplements that contain fucoidan
- Any allergy to fucoidan
- Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
- Be diagnosed with dementia.
- Be pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Minimizing Fatigue and Inflammation in Survivors of Cancer: A Pilot Randomized Clinical Trial of the Seaweed Supplement Fucoidan
To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation.
- Conditions
- Fatigue, Inflammation
- Being tested
- Fucoidan extracted from F. Vesiculosus, Fucoidan extracted from U. Pinnatifida
- Keywords
- cancer-related fatigue
- Medical subject headings
- Fatigue, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fucoidan extracted from F. VesiculosusDrug
4 g daily
Fucoidan extracted from U. PinnatifidaDrug
4 g daily
| Study group | Role | What they receive |
|---|---|---|
| Fucoidan | Experimental | They will receive 4 grams daily of fucoidan extracted from F. Vesiculosus for 8 weeks. Receives: Drug: Fucoidan extracted from F. Vesiculosus |
| Usual Care | Active comparator | They will receive usual care for 8 weeks followed by 4 grams daily of fucoidan extracted from U. Pinnatifida for 8 weeks. Receives: Drug: Fucoidan extracted from U. Pinnatifida |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of participants who are randomized to the study out of all participants approached
Measured: 8 weeks
percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention
Measured: 16 weeks
percentage of participants who take at least 80% of the fucoidan pills during the study
Measured: 8 weeks
Secondary outcomes (12)
mean change in Brief Fatigue Inventory
The Brief Fatigue Inventory is a 9-item questionnaire that ranges from 0 to 10 with higher scores indicating a worse outcome.
Measured: baseline to 16 weeks
mean change in plasma viscosity in blood
Measured: baseline to 16 weeks
mean change in erythrocyte sedimentation rate in blood
Measured: baseline to 16 weeks
mean change in thyroid stimulating hormone in blood
Measured: baseline to 16 weeks
mean change in C-reactive protein in blood
Measured: baseline to 16 weeks
mean change in leptin in blood
Measured: baseline to 16 weeks
mean change in D Dimer in blood
Measured: baseline to 16 weeks
mean change in TNF alpha in blood
Measured: baseline to 16 weeks
mean change in neopterin in blood
Measured: baseline to 16 weeks
mean change in lactase dehydrogenase in blood
Measured: baseline to 16 weeks
mean change in procalcitonin in blood
Measured: baseline to 16 weeks
mean change in frailty using a modified Fried's Frailty questionnaire
The modified Fried's Frailty questionnaire measures self-reported slowness, weakness, weight loss, physical activity and fatigue. The total score of the questionnaire ranges from 1 to 5 with higher numbers indicating worse outcome.
Measured: baseline 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 posted6 Mar 2024
- Study start26 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jeremy J McGuire, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295588
- Sponsor's protocol ID
- STUDY00009135
- Other IDs
- T32CA102618
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Fatigue and Inflammation in Survivors of Cancer: A Pilot Randomized Clinical Trial of the Seaweed Supplement Fucoidan
- ClinicalTrials.gov ID
- NCT06295588
- Acronym / sponsor ID
- STUDY00009135
- Conditions
- Fatigue, Inflammation
- Keywords
- cancer-related fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fucoidan | Experimental | Drug: Fucoidan extracted from F. VesiculosusThey will receive 4 grams daily of fucoidan extracted from F. Vesiculosus for 8 weeks. |
| Usual Care | Active comparator | Drug: Fucoidan extracted from U. PinnatifidaThey will receive usual care for 8 weeks followed by 4 grams daily of fucoidan extracted from U. Pinnatifida for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Survivors of cancer
- Age 18 or older
- Speak and understand English
- Have completed surgery, radiation, and/or systemic intravenous anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) ≤10 years prior to enrollment.
- Have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
Key exclusion criteria (6 listed)
- Current warfarin or other anti-coagulation medication use.
- Current use of supplements that contain fucoidan
- Any allergy to fucoidan
- Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
- Be diagnosed with dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fucoidan extracted from F. Vesiculosus4 g daily | Drug | Fucoidan |
| Fucoidan extracted from U. Pinnatifida4 g daily | Drug | Usual Care |
Primary outcome
percentage of participants who are randomized to the study out of all participants approached
Time frame: 8 weeks
percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention
Time frame: 16 weeks
percentage of participants who take at least 80% of the fucoidan pills during the study
Time frame: 8 weeks
12 secondary outcomes
mean change in Brief Fatigue Inventory
Time frame: baseline to 16 weeks
mean change in plasma viscosity in blood
Time frame: baseline to 16 weeks
mean change in erythrocyte sedimentation rate in blood
Time frame: baseline to 16 weeks
mean change in thyroid stimulating hormone in blood
Time frame: baseline to 16 weeks
mean change in C-reactive protein in blood
Time frame: baseline to 16 weeks
mean change in leptin in blood
Time frame: baseline to 16 weeks
mean change in D Dimer in blood
Time frame: baseline to 16 weeks
mean change in TNF alpha in blood
Time frame: baseline to 16 weeks
mean change in neopterin in blood
Time frame: baseline to 16 weeks
mean change in lactase dehydrogenase in blood
Time frame: baseline to 16 weeks
mean change in procalcitonin in blood
Time frame: baseline to 16 weeks
mean change in frailty using a modified Fried's Frailty questionnaire
Time frame: baseline to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fucoidan extracted from F. Vesiculosus and Fucoidan extracted from U. Pinnatifida in people with Fatigue and Inflammation, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of participants who are randomized to the study out of all participants approached (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.