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

NCT05954390 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-07-20

No results posted yet for this study

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.

Conditions

  • Change in Mood
  • Change in Personality

Interventions

DIETARY_SUPPLEMENT

Undenatured beta-glucan solution

The active comparator is a solution containing undenatured beta-glucans

OTHER

Placebo

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

Sponsors & Collaborators

  • OPIS USA

    collaborator OTHER

  • GlycaNova AS

    lead INDUSTRY

Principal Investigators

  • Stoil Borchev, MD · CLINECA EAD Hospital, Medical Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-20
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05954390 on ClinicalTrials.gov