A Cohort Study of Beta-Glucan or Beta-Glucan Compound in Metastatic Cancers

NCT04710290 | Unknown Phase 2

• 1 other identifier: EMRP50106N
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Immunity of cancer patients is an important issue. According to cancer immunity, it can be divided into three phases: clearance phase, equilibrium phase, and escape phase (cancer cells can avoid the recognition of immune cells). Βeta-glucans is extracted from yeast, it can increase immune function and drive of hematopoietic stem cells in animals and clinical trials. Glutamine can increase the repair of oral and intestinal mucosa of patients receiving chemical and radiation therapy and can increase the lymphocytes of patients. Colostrum contains IgA, IgG, IgM, etc., known to protect the baby Cancer patients who are infected with intestinal bacteria and undergo systemic chemotherapy are less immune than normal adults. Investigators will compare β-glucan, glutamine, and colostrum immunoglobulin powder with β-glucan and control group, each group has 30 people, and observe the side effects and blood of patients under standard chemotherapy. The performance of the immune system, such as helpers and cytotoxic T cells and NK cells, and to observe the differences in treatment interruption or delay rates and treatment rates.

Conditions

Metastatic Cancer; Chemotherapy

Keywords

beta-glucan; metastatic cancer; chemotherapy

Outcome Measures

Primary Outcomes (18)

• the change of total white blood cells, neutrophils, and lymphocytes at day 14 of 2nd cycle, from day 7 of 2nd cycle of chemotherapy

  the units of white blood cells, neutrophils, and lymphocytes are /ul.

  7days

• the change of total white blood cells, neutrophils, and lymphocytes at day 1 of 3rd cycle, from day 14 of 2nd cycle of chemotherapy

  the units of white blood cells, neutrophils, and lymphocytes are /ul

  14-21 days

• the change of total white blood cells, neutrophils, and lymphocytes at day 7 of 3rd cycle, from day 1 of 3rd cycle of chemotherapy

  the units of white blood cells, neutrophils, and lymphocytes are /ul.

  7 days

• the change of total white blood cells, neutrophils, and lymphocytes at day 7 of 4th cycle, from day 7 of 3rd cycle of chemotherapy

  the units of white blood cells, neutrophils, and lymphocytes are /ul.

  21-28 days

• the change of total white blood cells, neutrophils, and lymphocytes at day 1 of 5th cycle, from day 7 of 4th cycle of chemotherapy

  the units of white blood cells, neutrophils, and lymphocytes are /ul.

  14-21 days

• the change of total white blood cells, neutrophils, and lymphocytes at day 7 of 5th cycle, from day 1 of 5th cycle of chemotherapy

  the units of white blood cells, neutrophils, and lymphocytes are /ul.

  7 days

• the change of total white blood cells, neutrophils, and lymphocytes at day 1 of 6th cycle, from day 7 of 5th cycle of chemotherapy

  the units of white blood cells, neutrophils, and lymphocytes are /ul.

  14-21 days

• the change of total white blood cells, neutrophils, and lymphocytes at day 7 of 6th cycle, from day 1 of 6th cycle of chemotherapy

  the units of white blood cells, neutrophils, and lymphocytes are /ul.

  7 days

• the change of total white blood cells, neutrophils, and lymphocytes at day 22 of 6th cycle, from day 7 of 6th cycle of chemotherapy

  the units of white blood cells, neutrophils, and lymphocytes are /ul.

  15 days

• the change of total white blood cells, neutrophils, and lymphocytes at 2nd month after chemotherapy, from day 22 of 6th cycle of chemotherapy

  the units of white blood cells, neutrophils, and lymphocytes are /ul.

  63 days

• change of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and EORTC-quality-of-life questionnaire cervical cancer module (EORTC-QLQ-CX24 [Taiwan version]) score at C4D7 from C2D7

  total 54 questions. 1-4 points for each EORTC QLQ-C30 and EORTC QLQ-CX24 (Taiwan version) are continue question list, that contain total 54 questions. The questionnaire is divided into two parts.One is that the higher the score, the more obvious the uncomfortable symptoms.One is that the higher the score, the better the state, for example:1. The overall health score of the self-assessment in this week is 7 points, 1 point means very poor and 7 points means excellent.2. Self-assess the overall quality of life during the week. 1 point means very poor and 7 points means excellent.

  6-8 weeks

• change of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and EORTC-quality-of-life questionnaire cervical cancer module (EORTC-QLQ-CX24 [Taiwan version]) score at C6D22 from C4D7

  total 54 questions. 1-4 points for each EORTC QLQ-C30 and EORTC QLQ-CX24 (Taiwan version) are continue question list, that contain total 54 questions The questionnaire is divided into two parts.One is that the higher the score, the more obvious the uncomfortable symptoms.One is that the higher the score, the better the state, for example:1. The overall health score of the self-assessment in this week is 7 points, 1 point means very poor and 7 points means excellent.2. Self-assess the overall quality of life during the week. 1 point means very poor and 7 points means excellent.

  8-10 weeks

• change of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and EORTC-quality-of-life questionnaire cervical cancer module (EORTC-QLQ-CX24 [Taiwan version]) score at 2 month from C6D22

  total 54 questions. 1-4 points for each EORTC QLQ-C30 and EORTC QLQ-CX24 (Taiwan version) are continue question list, that contain total 54 questions The questionnaire is divided into two parts.One is that the higher the score, the more obvious the uncomfortable symptoms.One is that the higher the score, the better the state, for example:1. The overall health score of the self-assessment in this week is 7 points, 1 point means very poor and 7 points means excellent.2. Self-assess the overall quality of life during the week. 1 point means very poor and 7 points means excellent.

  9 -10 weeks

• the change of lymphocyte surface markers percentage at day 7 of 2nd chemotherapy, from baseline.

  the lymphocytes surface markers including:CD3, CD4, CD8, CD20, CD28, CD279, CD16, CD56, CD158a/h, CD158b, CD158e, CD158f, CD158i

  4-5 weeks

• the change of lymphocyte surface markers percentage at day 14 of 2nd chemotherapy, from day 7 of 2nd chemotherapy

  the lymphocytes surface markers including:CD3, CD4, CD8, CD20, CD28, CD279, CD16, CD56, CD158a/h, CD158b, CD158e, CD158f, CD158i

  7 days

• the change of lymphocyte surface markers percentage at day 7 of 4th cycle of chemotherapy, from day 14 of 2nd chemotherapy

  the lymphocytes surface markers including:CD3, CD4, CD8, CD20, CD28, CD279, CD16, CD56, CD158a/h, CD158b, CD158e, CD158f, CD158i

  5-7 weeks

• the change of lymphocyte surface markers percentage at day 22 of 6th cycle of chemotherapy, from day 7 of 4th cycle of chemotherapy

  the lymphocytes surface markers including:CD3, CD4, CD8, CD20, CD28, CD279, CD16, CD56, CD158a/h, CD158b, CD158e, CD158f, CD158i

  8-10 weeks

• the change of lymphocyte surface markers percentage at 2 month after 6th cycle of chemotherapy, from day 22 of 6th cycle of chemotherapy

  the lymphocytes surface markers including:CD3, CD4, CD8, CD20, CD28, CD279, CD16, CD56, CD158a/h, CD158b, CD158e, CD158f, CD158i

  5 weeks

Secondary Outcomes (1)

• analysis overall survival

  2 years

Study Arms (3)

Solid beverage powder

EXPERIMENTAL

Whey portein solid beverage powder use 1 pack for every 10 kg of body weight. A total of 6 pack under 60 kg a day, an extra 1pack for each additional 10 kg over 60 kg.Use from the 7th day of the 2nd course of treatment for 5 months.

Dietary Supplement: Beta-Glucan; Dietary Supplement: Glutamine; Dietary Supplement: Immunoglobuin

Capsule

EXPERIMENTAL

Capsules use 1 cap for every 10 kg of body weight.A total of 6 cap under 60 kg a day, an extra 1cap for each additional 10 kg over 60 kg. Use from the 7th day of the 2nd course of treatment for 5 months.

Dietary Supplement: Beta-Glucan

Placebo

PLACEBO COMPARATOR

placebo use 1 powder for every 10 kg of body weight. A total of 6 pack under 60 kg a day, an extra 1pack for each additional 10 kg over 60 kg.Use from the 7th day of the 2nd course of treatment for 5 months.

Dietary Supplement: Corn starch

Interventions

Beta-Glucan DIETARY_SUPPLEMENT

Solid beverage powders, capsules and placebo were randomly assigned. The main components of the solid beverage powder are beta-glucan combined with glutamine and immunoglobuin.and the main component of the capsule is beta-glucan . The main ingredient of placebo is corn starch.

Capsule; Solid beverage powder

Glutamine DIETARY_SUPPLEMENT

Solid beverage powders, capsules and placebo were randomly assigned. The main components of the solid beverage powder are beta-glucan combined with glutamine and immunoglobuin.and the main component of the capsule is beta-glucan . The main ingredient of placebo is corn starch.

Solid beverage powder

Immunoglobuin DIETARY_SUPPLEMENT

Solid beverage powders, capsules and placebo were randomly assigned. The main components of the solid beverage powder are beta-glucan combined with glutamine and immunoglobuin.and the main component of the capsule is beta-glucan . The main ingredient of placebo is corn starch.

Solid beverage powder

Corn starch DIETARY_SUPPLEMENT

Solid beverage powders, capsules and placebo were randomly assigned. The main components of the solid beverage powder are beta-glucan combined with glutamine and immunoglobuin.and the main component of the capsule is beta-glucan . The main ingredient of placebo is corn starch.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with metastatic cancer receiving systemic chemotherapy
• ECOG=0,1
• Age ≥20 years
• Chemotherapy drugs include platinum drugs (cisplatin, carboplatin, oxaliplatin), irinotecan / topotecan, paclitaxel (docetaxel), fluorouracil (5-FU), and alkylating drugs (such as cyclophosphamide)

You may not qualify if:

• Early cancer patients.
• Patients receiving systemic chemotherapy or large-area radiation therapy 6 months before chemotherapy.
• The patient had a history of allergies to β-glucan or glutamine.
• Patients with liver dysfunction not associated with cancer. (GOT\> 2 × ULN; GPT\> 2 × ULN)
• Patients with abnormal renal function (creatinine over 2 mg / dl)
• Age \<20 years

Sponsors & Collaborators

• E-DA Hospital: lead

Study Sites (1)

E-DA hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

beta-Glucans; Glutamine; Starch

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: this trial is single-blind clinical trial
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: beta-glucan group; beta-glucan + glutamin; placebo

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: January 14, 2021
• Study Start: January 4, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)