Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Folic Acid Deficiency

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Olaparib

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Folic Acid supplement 1 mg by mouth daily

Folic Acid Tablet

This is a study investigating folate deficiency (lack of folic acid in the blood) in patients who take the drug olaparib to treat their advanced ovarian or breast cancer. The primary goal of this study is to determine the frequency and timing of folate deficiency, and to learn more about whether giving folic acid supplements (vitamins) will help delay or avoid deficiency in these patients. Deficiency can cause doctors to reduce or stop treatment with olaparib. In this case, patients are not getting the best treatment for their cancer due to the unwanted side effect.

A Study of Serum Folate Levels in Patients Treated With Olaparib

The frequency of folate deficiency in patients with ovarian and breast cancers who are treated with olaparib will be measured.

The timing of folate deficiency in patients with ovarian and breast cancers who are treated with olaparib will be measured.

To evaluate the effect of folic acid supplementation on hemoglobin level, CBC will be measured every 2 weeks for the first 3 months, and then monthly thereafter for duration of olaparib therapy. Hematological toxicity will be assessed by utilizing CTC Version 4.0.

To evaluate the effect of folic acid supplementation on serum folate levels, serum folate will be measured every 2 weeks for the first 3 months, and then monthly thereafter for duration of olaparib therapy.

The number of blood transfusions during olaparib treatment will be measured.

The number of interruptions in olaparib treatment will be measured.

The number of reductions in olaparib treatment will be measured.

The number of subjects who have their olaparib treatments discontinued will be measured.

The response rate will be assessed by treating physicians. The data on the response rate will be collected and correlated with hematologic toxicity, serum folate level, and folic acid supplementation.

Investigators will compare progression free survival in Lynparza- treated patient with folate deficiency who were subsequently treated with folic acid to those who did not develop folate deficiency and did not require supplementation.

Rush University Medical Center

Associate Professor of Medicine

Precancerous Conditions

Experiment group: oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day, + oral administration of Folic Acid Tablet simulation half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.

Control group: oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day, + oral administration of folic acid tablets half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks.

oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day

MoLuoDan

oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day

Sanchi powder

oral administration of folic acid tablets half an hour after meal for 5 mg each time for 3 times a day.

oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day

MoLuoDan simulation

oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day

Sanchi powder simulation

oral administration of folic acid simulation tablets half a hour after meal for 5 mg each time for 3 times a day.

Folic Acid Tablet simulation

Xiangxue Ma, Doctor

Xiangxue Ma

This study had adopted the multi-center, randomized and controlled experiment design based on standardized mucosal biopsy and pathohistological operation, as well as therapeutic evaluation methodology. Meanwhile, patients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia (grade C2/C3 of Vienna classification) confirmed by gastroscopic histopathology were enrolled as the objects of study, while folic acid was used as the control. The therapeutic effect and safety of Jianpi Huoxue Recipe (Moluodan + Sanchi powder) in intervening the gastric Premalignant lesion were evaluated from the points of view of pathology, gastroscopy and symptoms. The elimination rate of intraepithelial neoplasia of gastric mucosa was expected to be improved by 9-12%. Moreover, high quality evidence-based medical evidence regarding traditional Chinese medicine (TCM) in intervening gastric Premalignant lesion would be obtained, which could form the mature, propagable and effective scheme.

Intraepithelial neoplasia of gastric mucosa is a well-recognized gastric Premalignant lesion, which is the key of secondary prevention for gastric cancer. However, no universally acknowledged effective therapeutic scheme is available at present. Previously, the investigator's research group has carried out clinical trial study based on solving the key problems such as diagnostic criteria, mucosal biopsy consistency and therapeutic evaluation methodology, and has attained certain achievements. This study had adopted the multi-center, randomized and controlled experiment design based on standardized mucosal biopsy and pathohistological operation, as well as therapeutic evaluation methodology. Meanwhile, patients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia (grade C2/C3 of Vienna classification) confirmed by gastroscopic histopathology were enrolled as the objects of study, while folic acid was used as the control. The therapeutic effect and safety of Jianpi Huoxue Recipe (Moluodan + Sanchi powder) in intervening the gastric Premalignant lesion were evaluated from the points of view of pathology, gastroscopy and symptoms. The elimination rate of intraepithelial neoplasia of gastric mucosa was expected to be improved by 9-12%. Moreover, high quality evidence-based medical evidence regarding traditional Chinese medicine (TCM) in intervening gastric Premalignant lesion would be obtained, which could form the mature, propagable and effective scheme. At the same time, molecular and biological indicators, including CDX2, SOX2, MUC2, MUC6, MUC5AC and CD10, were detected using the pathological tissues, so as to explore the therapeutic mechanism of Jianpi Huoxue Recipe in intervening gastric Premalignant lesion, and to construct the model platform for special disease research on gastric Premalignant lesion.

Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion

Therapeutic Mechanism of Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion：A Multi-center, Randomized and Controlled Experiment

The all patients' histopathology will be evaluated two times, the first time is when the patients' are included into the clinical trials, the second time is after 24 weeks treatment in each group, patients' histopathology should be evaluated for comparison between two groups,at the same time patients' histopathology should be evaluated for comparison in each group.The change in histological score (mean score of all biopsie after treatment in each group and between groups was calculated. The response rate of each pathological lesion was calculated as a percentage of those improved or disappeared at the 6th month to all subjects. The disappearance rate of dysplasia between groups were compared, which was defined as the absence of dysplasia (score 0) in all biopsy specimens after treatment.

The score changes of atrophy, intestinal metaplasia, chronic inflammation and active inflammation compared between baseline and after 6-month treatment.

The score changes of endoscopic findings, such as erosion, bleeding, coarse and uneven mucosa, and bile reflux were compared between baseline and after 6-month treatment.

Changes of symptom score were compared. The symptom include upper abdominal pain, upper abdominal distension, poor appetite, nausea and belching. The disappearance rate of symptom was expressed as a percentage of the subjects whose symptoms disappeared after medication to those exhibiting symptoms before medication.

The patient-reported outcome (PRO) instrument for chronic gastrointestinal diseases was a 35-item instrument, including 6 dimensions of regurgitation, dyspepsia, defecation, general condition, emotion and social function. All items graded into 5 levels and scored 0-4, except for decreased appetite, which is grouped into 4 levels and scored 0-3.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Serum Folate Levels in Patients Treated With Olaparib	NCT04024254	Ovarian Cancer Breast Cancer Folic Acid Defi...	Folic Acid Tabl...	18 Years -	Rush University Medical Center
Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion	NCT03823248	Gastric Precanc...	MoLuoDan Sanchi powder Folic Acid Tabl... MoLuoDan simula... Sanchi powder s... Folic Acid Tabl...	18 Years - 75 Years	Xiyuan Hospital of China Academy of Chinese Medical Sciences

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