Change in MoodNCT05954390
The Effect of LentinexHP® on Quality of Life in Stage IV Colorectal Cancer
A study testing Undenatured beta-glucan solution in people with Change in Mood and Change in Personality, run by GlycaNova AS at 1 site in Bulgaria.
Trial summary
This is a randomized, double-blind parallel-group, placebo-controlled study. that will last 40 weeks and will focus on Quality of Life.36 Subjects with stage IV metastatic colorectal cancer will be referred for study inclusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Change in Mood, Change in Personality
- What is being tested?
- Undenatured beta-glucan solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBulgaria
- Study dates
- 20 May 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Signed written informed consent.
- Age 18 years or older.
- Male or female.
- Patients with stage IV metastatic colorectal cancer with less than three metastatic sites.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Patients starting on 1st or 2nd line chemotherapy with a 5-fluorouracil (5-FU) based regimen with or without biologics.
Who cannot join
- Patients with known or suspected hypersensitivity to any of the components of the test food supplement.
- Pregnant or breastfeeding.
- Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (COVID-19 drugs recommended by local regulatory authorities are permitted).
- Patients who in the opinion of the treating physician should not participate in this program.
- Prisoners.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site, 1 recruiting
- Recruiting
CLINECA EAD Hospital
Haskovo
Stoil B Boychev, MD, +359 884 513 464, dr.stoil.boichev@gmail.com
Lyubomira T Mavrova, +359 884 513 464
About this study
Official title: The Effect of LentinexHP® on Quality of Life in Stage IV Colorectal Cancer: a Randomized, Parallel-group, Placebo-controlled Study
This is a randomized, double-blind parallel-group, placebo-controlled study. that will last 40 weeks and will focus on Quality of Life.36 Subjects with stage IV metastatic colorectal cancer will be referred for study inclusion. Patients will be randomly assigned (1:1 ratio) to take 2 ml of LentinexHP or placebo orally twice a day (a total of 6 mg). Products will be dispensed to allow administration of the product for six weeks. Each bottle of LentinexHP or placebo contains 30 mL, which at 1.5 mg/mL will provide dosage for approximately five days. The patients will periodically complete the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Quality of Life (QoL) instrument, the short form 36 (SF-36), the Fatigue Symptom Inventory (FSI), and the QoL questionnaire used in the previous LentinexHP QoL study.
Read the detailed description
This is a randomized, double-blind parallel-group, placebo-controlled study. Subjects with stage IV metastatic colorectal cancer identified by the Principal Investigator or other qualified oncologists will be referred for potential study inclusion.
- Baseline Visit (Week 1) After written informed consent and verification of eligibility criteria, patients will be randomly assigned (1:1 ratio) to take 2 ml of LentinexHP or placebo orally twice a day (a total of 6 mg). Products will be dispensed to allow administration of the product for six weeks. Each bottle of LentinexHP or placebo contains 30 mL, which at 1.5 mg/mL will provide dosage for approximately five days.
Patient demographics, blood chemistries, complete blood count (CBC), and vital signs, will be obtained from the patient's medical records and included as part of the study.
The patients will then complete the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Quality of Life (QoL) instrument, the short form 36 (SF-36), the Fatigue Symptom Inventory (FSI), and the QoL questionnaire used in the previous LentinexHP QoL s
- Visit 2 (Week 6) After six weeks, patients will be asked to return to the clinic and return used/unused bottles of LentinexHP or placebo for compliance evaluation. Patients will evaluate their QoL over the first six weeks of supplementation through the FACT-C, SF-36, FSI and the QoL questionnaire used in a prior LentinexHP study assessing QoL. Any self-perceived adverse events (AE) will be discussed with the patient. The Investigator will also review cancer treatments, vital signs and blood data (if available) to assess for any changes that might have occurred over the first six-week period.
- Visit 3 (Week 12) Patients will return to the clinic with their used/unused bottles of LentinexHP or placebo and again fill out the various QoL questionnaires. As in Visit 2, cancer treatments, blood data and vital signs obtained from medical records will be reviewed.
At this time patients will be given the option of taking LentinexHP free of charge for an additional 40 weeks. If they select that option, the sponsor will send them a 6-week supply of LentinexHP along with the four questionnaires to complete. After receiving the completed questionnaires for each 6-week period, another shipment of LentinexHP for the next 6 weeks will automatically be sent to the patients. Patients will be called every six weeks to enquire about survival, cancer treatments and any adverse events.
The duration of the study for each patient is 12 weeks, extending up to one year for patients opting to continue supplementation after the initial 12-week period.
- Conditions
- Change in Mood, Change in Personality
- Being tested
- Undenatured beta-glucan solution, Placebo
- Keywords
- B-Glucan, Quality-of-Life, Colerectal Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Undenatured beta-glucan solutionDietary supplement
The active comparator is a solution containing undenatured beta-glucans
PlaceboOther
The placebo comparator is the same solution as the active therapy except it does not contain any undenatured beta-glucans
| Study group | Role | What they receive |
|---|---|---|
| Active Therapy | Active comparator | The active comparator intervention is a solution containing undenatured beta-glucans Receives: Dietary Supplement: Undenatured beta-glucan solution |
| Placebo | Placebo comparator | The placebo comparator intervention is the same solution used in the active comparator intervention except it does not contain any beta-glucans Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective: * The primary objective of the study is to explore the effect of LentinexHP versus placebo as an add-on non-drug therapy to improve QoL in patients with stage IVmetastatic colorectal cancer.
The primary Instrument to be used for evaluation of the QoL is a validated 27-item questionnaire (FACT-C) designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. The FACT-C questionnaire assess the quality of life concerns pertinent to colorectal cancer patients.at weeks, 0 (baseline), 6 and 12. The scale has a numerical value from 0 to 9, where the rating of 0 means the patient feels worse than they did at a previous time point, and a rating of 9 means the patient feels much better than they did at a previous time point. Values between 0 and 9 reflect relative feelings on that day.
Measured: 12 Weeks
Secondary outcomes (1)
Secondary Objective (Outcome 2)* A secondary objective of this study is to evaluate the patients' self-perception of their overall health.
A secondary Instrument to be used for evaluation of the QoL is the validated 36-Item Short Form Survey (SF-36). This is an outcome measure instrument that is often used self-reported measure of health. SF-36 scores range from 0 (worst) to 100 (best) (5). This instrument addresses health concepts from the patient's perspective. The SF-36 questionnaire assesses the quality of life at weeks 0 (baseline), 6 and 12.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start20 May 2023
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Change in MoodStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlycaNova AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OPIS USA
- Responsible party
- Sponsor
- Investigators
- Stoil Borchev, MD, Principal investigator, CLINECA EAD Hospital, Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954390
- Sponsor's protocol ID
- GNAS-22-01
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available to other researchers and/or recognized organizations upon request, at the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of LentinexHP® on Quality of Life in Stage IV Colorectal Cancer: a Randomized, Parallel-group, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05954390
- Acronym / sponsor ID
- GNAS-22-01
- Conditions
- Change in Mood, Change in Personality
- Keywords
- B-Glucan, Quality-of-Life, Colerectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- GlycaNova ASIndustry (pharma, biotech, devices)
- Collaborators
- OPIS USA
- Study start
- 20 May 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Jul 2023 (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.
This is a randomized, double-blind parallel-group, placebo-controlled study. that will last 40 weeks and will focus on Quality of Life.36 Subjects with stage IV metastatic colorectal cancer will be referred for study inclusion. Patients will be randomly assigned (1:1 ratio) to take 2 ml of LentinexHP or placebo orally twice a day (a total of 6 mg). Products will be dispensed to allow administration of the product for six weeks. Each bottle of LentinexHP or placebo contains 30 mL, which at 1.5 mg/mL will provide dosage for approximately five days. The patients will periodically complete the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Quality of Life (QoL) instrument, the short form 36 (SF-36), the Fatigue Symptom Inventory (FSI), and the QoL questionnaire used in the previous LentinexHP QoL study.
Detailed description
This is a randomized, double-blind parallel-group, placebo-controlled study. Subjects with stage IV metastatic colorectal cancer identified by the Principal Investigator or other qualified oncologists will be referred for potential study inclusion.
- Baseline Visit (Week 1) After written informed consent and verification of eligibility criteria, patients will be randomly assigned (1:1 ratio) to take 2 ml of LentinexHP or placebo orally twice a day (a total of 6 mg). Products will be dispensed to allow administration of the product for six weeks. Each bottle of LentinexHP or placebo contains 30 mL, which at 1.5 mg/mL will provide dosage for approximately five days.
Patient demographics, blood chemistries, complete blood count (CBC), and vital signs, will be obtained from the patient's medical records and included as part of the study.
The patients will then complete the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Quality of Life (QoL) instrument, the short form 36 (SF-36), the Fatigue Symptom Inventory (FSI), and the QoL questionnaire used in the previous LentinexHP QoL s
- Visit 2 (Week 6) After six weeks, patients will be asked to return to the clinic and return used/unused bottles of LentinexHP or placebo for compliance evaluation. Patients will evaluate their QoL over the first six weeks of supplementation through the FACT-C, SF-36, FSI and the QoL questionnaire used in a prior LentinexHP study assessing QoL. Any self-perceived adverse events (AE) will be discussed with the patient. The Investigator will also review cancer treatments, vital signs and blood data (if available) to assess for any changes that might have occurred over the first six-week period.
- Visit 3 (Week 12) Patients will return to the clinic with their used/unused bottles of LentinexHP or placebo and again fill out the various QoL questionnaires. As in Visit 2, cancer treatments, blood data and vital signs obtained from medical records will be reviewed.
At this time patients will be given the option of taking LentinexHP free of charge for an additional 40 weeks. If they select that option, the sponsor will send them a 6-week supply of LentinexHP along with the four questionnaires to complete. After receiving the completed questionnaires for each 6-week period, another shipment of LentinexHP for the next 6 weeks will automatically be sent to the patients. Patients will be called every six weeks to enquire about survival, cancer treatments and any adverse events.
The duration of the study for each patient is 12 weeks, extending up to one year for patients opting to continue supplementation after the initial 12-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Therapy | Active comparator | Dietary Supplement: Undenatured beta-glucan solutionThe active comparator intervention is a solution containing undenatured beta-glucans |
| Placebo | Placebo comparator | Other: PlaceboThe placebo comparator intervention is the same solution used in the active comparator intervention except it does not contain any beta-glucans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written informed consent.
- Age 18 years or older.
- Male or female.
- Patients with stage IV metastatic colorectal cancer with less than three metastatic sites.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Key exclusion criteria (5 listed)
- Patients with known or suspected hypersensitivity to any of the components of the test food supplement.
- Pregnant or breastfeeding.
- Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (COVID-19 drugs recommended by local regulatory authorities are permitted).
- Patients who in the opinion of the treating physician should not participate in this program.
- Prisoners.
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 |
|---|---|---|
| Undenatured beta-glucan solutionThe active comparator is a solution containing undenatured beta-glucans | Dietary supplement | Active Therapy |
| PlaceboThe placebo comparator is the same solution as the active therapy except it does not contain any undenatured beta-glucans | Other | Placebo |
Primary outcome
Primary Objective: * The primary objective of the study is to explore the effect of LentinexHP versus placebo as an add-on non-drug therapy to improve QoL in patients with stage IVmetastatic colorectal cancer.
Time frame: 12 Weeks
The primary Instrument to be used for evaluation of the QoL is a validated 27-item questionnaire (FACT-C) designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. The FACT-C questionnaire assess the quality of life concerns pertinent to colorectal cancer patients.at weeks, 0 (baseline), 6 and 12. The scale has a numerical value from 0 to 9, where the rating of 0 means the patient feels worse than they did at a previous time point, and a rating of 9 means the patient feels much better than they did at a previous time point. Values between 0 and 9 reflect relative feelings on that day.
1 secondary outcome
Secondary Objective (Outcome 2)* A secondary objective of this study is to evaluate the patients' self-perception of their overall health.
Time frame: 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Yes. All data will be available to other researchers and/or recognized organizations upon request, at the end of the study
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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.
Stoil Borchev, MD principal investigator
CLINECA EAD Hospital, Medical Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Undenatured beta-glucan solution in people with Change in Mood and Change in Personality, run by GlycaNova AS at 1 site in Bulgaria.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Jul 2023. 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 Bulgaria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stoil Boichev, MD (+359889214157, dr.stoil.boichev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective: * The primary objective of the study is to explore the effect of LentinexHP versus placebo as an add-on non-drug therapy to improve QoL in patients with stage IVmetastatic colorectal cancer. (time frame: 12 Weeks). 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 20 Jul 2023.