Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Diarrhea

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Signs and Symptoms, Digestive

All Drugs and Chemicals

Dermatologic Agents

Other Dietary Supplements

Amino Acids

Tyrosine Kinase Inhibitors

Astringents

Acidophilus

Tyrosine

Glutamine

Astringent diet supplemented with one sachet containing 10 grams of glutamine plus 100 million Colony Forming Units (CFU) of Lactobacillus reueri every 12 hours, from baseline treatment up to 6 weeks or death.

Astringent diet from baseline treatment up to 6 weeks or death.

Glutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death

Glutamine plus L. reuteri

Oscar G Arrieta Rodriguez, M.D., M.Sc.

This open-label randomized clinical trial aims to evaluate the glutamine plus Lactobacillus reuteri supplementation effect in a standard-of-care diet in EGFR mutant patients with advanced non-small cell lung cancer (NSCLC) under tyrosine kinase inhibitors (TKIs) therapy.

The main question it aims to answer is ¿What is the effect of glutamine plus L. reuteri added to an astringent diet in preventing diarrhea generated by TKI therapy?

Patients will receive an astringent diet supplemented with 10 grams of glutamine and L. reuteri (100 million CFU). Researchers will compare the Glutamine plus L. reuteri diet with a standard astringent diet to see if TKI therapy diarrhea is prevented.

Patients in the experimental group will receive two sachets of Glutapak-R every twelve hours for up to six weeks alongside treating physician-chosen EGFR therapy. Patients in the control group will receive a standard-of-care diet.

All patients will receive nutritional counseling every two weeks.

Patients with Non-Small Cell Lung Cancer and EGFR Mutation receiving first or second generation-TKI therapy.

Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC

Effect of Glutamine Plus Lactobacillus Reuteri Added to an Astringent Diet in Preventing Diarrhea Caused by Tyrosine Kinase Inhibitors (TKIs) in Patients With Advanced Non-small Cell Lung Cancer

The diarrhea grade will be determined from 1 to 5 following the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. As shown below:

grade 1: Increase of \< 4 stools per day over baseline; mild increase in ostomy output compared to baseline grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental ADL.

grade 3: Increase of \>= 7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL.

grade 4: Life-threatening consequences; urgent intervention indicated grade 5: Death

This assessment will be evaluated with a specific scale for diarrhea (FACIT instrument), which consists of 11 items that assign a value of 0 to 4 for each one. Higher the score, the better quality of life related to diarrhea.

This outcome will be determined from grades 1 to 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for gastrointestinal disorders.

The QoL of patients with cancer will be determined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 (EORTC QLQ-C30 v3.0) instrument.

The QoL for Lung Cancer patients will be determined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 (EORTC QLQ-LC13) instrument.

Instituto Nacional de Cancerologia de Mexico

Head of the Thoracic Oncology Unit and Personalized Medicine Laboratory

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Subjects received two probiotic sachets per day

Subjects received two placebo sachets per day

Three-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive).

Probiotic

Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.

Placebo

Fang-Kuei Lin, Master

Wan-Hua Tsai, PhD

Po-Sheng Yang, MD, PhD

Chemotherapy-associated side-effects would affect therapeutic effect, quality of life, and cause permanent harm to breast cancer patients. This study is designed to explore after consumption of probiotics of lactobacillus composite strain powder sachets for 6 months in breast cancer chemotherapy, and whether the improvement of meliorate the side effects, further assists patients completing the chemotherapy.

In 2020, the incidence rate of women's breast cancer in Taiwan was up to 82.1% . The death rate increased to 16%; in 2021, the ranking rose to no.3, and the death rate grew up to 24.6%. In the decades, breast cancer gradually becomes the dominant malignant women's cancer in Taiwan. Besides the lumpectomy, chemotherapy is one of the dominant and important treatments for breast cancer. Beyond the effects of chemotherapy, several side effects rise up. The most common chemotherapy are anthracyclin drugs (doxorubicin and epirubicin) and taxane (docetaxel and paclitaxel ). There are common side effects including neutropenia, hair loss, vomiting, diarrhea, stomatitis, mucositis, peripheral neuropathy, dermatitis, nephrotoxicity, and hepatotoxicity. Currently, most treatments for chemotherapy-induced side effects are symptomatic treatment, but there is no good solution to prevent it.

Parallel Assignment, Randomized Controlled Trial

To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer

To Evaluate the Efficacy of Probiotics in Improvement and Prevention of Chemotherapy Associated Side Effectes in Patients With the Breast Cancer

The questionnaire will finished to record the side effects, including nausea, vomiting, diarrhea, stomatitis, peripheral neuropathy, skin rashes, and hand-food syndrome before and after the treatment.

The FACT-G questionnaire will record the quality of life by subjects at 12-weeks and-24 weeks. There are 4 domains of quality of life will be measured, including physical well-being, social/family well-being, emotional well-being, functional well-being. All domains will sum as total score of 108, and each domain will also evaluated.

BMI will calculated with weight and height combined in kg/m\^2. Measured every visit (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

Blood samples will collected to examine the variation of hs-CRP from baseline at 12 weeks.

Blood samples will collected to examine the variation of hs-CRP from baseline at 24 weeks.

Blood samples will collected to examine the variation of IL-6 from baseline at 12 weeks.

Blood samples will collected to examine the variation of IL-6 from baseline at 24 weeks.

Blood samples will collected to examine the variation of IL-10 from baseline at 12 weeks.

Blood samples will collected to examine the variation of IL-10 from baseline at 24 weeks.

Blood samples will collected to examine the variation of TNF-α from baseline at 12 weeks.

Blood samples will collected to examine the variation of TNF-α from baseline at 24 weeks.

Fecal sample will collected to extract DNA from the intestinal microbiota to examine the variations of gut microbiome from baseline at 12 weeks by NGS (Next Generation Sequencing) analysis.

Fecal sample will collected to extract DNA from the intestinal microbiota to examine the variations of gut microbiome from baseline at 24 weeks by NGS (Next Generation Sequencing) analysis.

ALT levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

AST levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

Creatinine levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

Hb levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

RBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

Ht levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

WBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

MCV levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

MCH levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

MCHC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

Total neutrophils and WBC collected from routine medical records at each visit to calculate ANC levels. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) ANC is calculated as 10 x WBC count in 1000s x (%Segment neutrophils + % bands neutrophils).

Platelet levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC	NCT05852990	Non-Small Cell ...	Glutamine plus ...	18 Years - 80 Years	Instituto Nacional de Cancerologia de Mexico
To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer	NCT06039644	Breast Cancer	Probiotic Placebo	20 Years - 80 Years	GenMont Biotech Incorporation
To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer	NCT06039644	Breast Cancer	Probiotic Placebo	20 Years - 80 Years	GenMont Biotech Incorporation
To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer	NCT06039644	Breast Cancer	Probiotic Placebo	20 Years - 80 Years	GenMont Biotech Incorporation
Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC	NCT05852990	Non-Small Cell ...	Glutamine plus ...	18 Years - 80 Years	Instituto Nacional de Cancerologia de Mexico

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