Clinical trial · Interventional
The Effect of LentinexHP® on Quality of Life in Stage IV Colorectal Cancer
The Effect of LentinexHP® on Quality of Life in Stage IV Colorectal Cancer: a Randomized, Parallel-group, Placebo-controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Change in Mood | — | UNRESOLVED | — |
| Change in Personality | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Undenatured beta-glucan solution | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active Therapy
- description
- The active comparator intervention is a solution containing undenatured beta-glucans
- interventionNames
- Dietary Supplement: Undenatured beta-glucan solution
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- The placebo comparator intervention is the same solution used in the active comparator intervention except it does not contain any beta-glucans
- interventionNames
- Other: Placebo
Primary outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available