The Effect of LentinexHP® on Quality of Life in Stage IV Colorectal Cancer

NCT ID: NCT05954390

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-20
• Study Completion Date: 2024-12-31

Brief 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. 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.

Conditions

Change in Mood; Change in Personality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Therapy

The active comparator intervention is a solution containing undenatured beta-glucans

Group Type: ACTIVE_COMPARATOR

Undenatured beta-glucan solution

Intervention Type: DIETARY_SUPPLEMENT

The active comparator is a solution containing undenatured beta-glucans

Placebo

The placebo comparator intervention is the same solution used in the active comparator intervention except it does not contain any beta-glucans

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The placebo comparator is the same solution as the active therapy except it does not contain any undenatured beta-glucans

Interventions

Undenatured beta-glucan solution

The active comparator is a solution containing undenatured beta-glucans

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The placebo comparator is the same solution as the active therapy except it does not contain any undenatured beta-glucans

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OPIS USA

OTHER

Sponsor Role: collaborator

GlycaNova AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stoil Borchev, MD

Role: PRINCIPAL_INVESTIGATOR

CLINECA EAD Hospital, Medical Oncology

Locations

CLINECA EAD Hospital

Haskovo, , Bulgaria

Site Status: RECRUITING

Countries

Bulgaria

Central Contacts

Stoil Boichev, MD

Role: CONTACT

dr.stoil.boichev@gmail.com

+359889214157

Lybomira T Mavrova

Role: CONTACT

luobomira.vavrova@clinica.net

+359884513464

Facility Contacts

Stoil B Boychev, MD

Role: primary

dr.stoil.boichev@gmail.com

+359 884 513 464

Lyubomira T Mavrova

Role: backup

+359 884 513 464

Other Identifiers

GNAS-22-01

Identifier Type: -

Identifier Source: org_study_id