Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Carcinoma

Breast Neoplasms

Recurrence

Flushing

Carcinoma in Situ

Carcinoma, Lobular

Breast Carcinoma In Situ

Hot Flashes

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Tamoxifen

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Soy Bean

All patients receive placebo for 7 days as part of the run-in period. Patients being treated with tamoxifen were randomized to treatment arm I and received 40 gm soy protein and 90 mg isoflavones daily for 12 weeks.

All patients receive placebo for a 7 day run in period. Patients being treated with tamoxifen randomized to Arm II received placebo daily for 12 weeks.

soy protein

isoflavones

Placebo

Gini F. Fleming, MD

RATIONALE: Soy protein supplement may be effective in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast disease.

PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast disease such as ductal hyperplasia or breast cancer.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to duration of hot flashes (less than 9 months vs 9 months or more) and frequency of hot flashes (7 to 9 per day vs more than 9 per day). For more information regarding the treatment regimens, please see the treatment arms section.

Primary objectives:

1. To compare the effect of daily soy supplementation versus placebo on the daily number of hot flushes experienced by postmenopausal women taking tamoxifen measured at three months from baseline
2. To compare the effect of daily soy supplementation versus placebo on hot flush severity as measured by the average daily hot flash score in this population of women measured at three months from baseline

Secondary objectives:

1. To evaluate the effect of soy supplementation as compared to women randomized to placebo on quality of life as measured by the Medical Outcomes Study (MOS) sleep subscale, the Mental Health Inventory (MHI), the CES-D Short Form, the Menopause and Reproductive Health Questionnaire, and the General Quality of Life Form
2. To measure the effect of soy supplementation as compared to women randomized to placebo on serum isoflavones, estradiol, SHBG, IGF1 and IGFBP3 levels as measures of hormonal change
3. To estimate the effect of daily soy supplementation versus placebo on the time to first relief of hot flushes

A total of 112 patients accrued on this study. Patients were followed 6 months post-randomization.

Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease

Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen

National Cancer Institute (NCI)

Protein Technologies International

Alliance for Clinical Trials in Oncology

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Sarcopenia

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Muscular Atrophy

Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Other Dietary Supplements

Whey Protein

This group received dietary guidance and soy protein intervention for 3 months

This group received dietary guidance and whey protein intervention for 3 months

This group received dietary guidance and ｍltodextrin for 3 months

The intervention is made up of soy protein supplements (30g/d) and dietary pattern modification.

The intervention is made up of whey protein supplements (30g/d) and dietary pattern modification.

whey protein

The intervention is made up of maltodextrin (30g/d) and dietary pattern modification.

placebo

Kang Yu, MD

Yu Zang, MD

Sarcopenia is common in lung cancer patients. It is one of the significant factors affecting the overall survival, radiotherapy and chemotherapy efficacy, and quality of life of patients with lung cancer. Previous studies have shown that increased protein intake can stimulate postprandial muscle synthesis, and improve muscle mass, strength, function, and overall survival. However, most previous studies have focused on the intervention of whey protein, while the protective effect of soybean protein on lung cancer-related sarcopenia (LCRS) has not yet been fully explored and reached an agreement.

So, this study aims to explore the effects of soy and whey protein on muscle, gut microbiota, and clinical outcomes among patients with lung cancer-related sarcopenia, to provide a reference for further nutrition treatment.

This study will last 6 months. For the duration of the study, an anticipated total of 90 participants will be randomly assigned to receive either a 30-gram protein supplement or a placebo daily. There will be a total of 5 study visits, and dietary records, questionnaires, blood and stool collection, and functional testing will occur at all study visits. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be conducted in statistical analysis.

Effects of Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia

Effects of Soy Protein and Whey Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia（LCRS）: a Randomized, Double-blind, Controlled Clinical Study

Measured by Short Physical Performance Battery (0-12) with higher scores meaning better physical performance.

Measured by FRAIL scale (0-5) with higher scores meaning better physical function.

Measured by EuroQol- 5 Dimension scale (0-5) with higher scores meaning better Quality of life.

The stool samples of participants before and after intervention were collected and analized by 16S rRNA.

Completing initially planned chemotherapy course is defined as good tolerance; dose adjustment, delayed completion or interruption of treatment are considered as poor tolerance.

Measured after initiation of chemotherapy using the WHO Toxicity Grades (gradeI-IV) with higher grades neaning severer chemotheraphy toxicity.

Peking Union Medical College Hospital

Professor

Rare Diseases

Chronic Pain

Chronic Disease

Pain

Disease Attributes

Chronic Graft Versus Host Disease

Caseins

Chelating Agents

30-50g of protein powder daily for 2 weeks.

Isolated soy protein

Isolated milk protein

Yoram Shir, MD

The incidence of chronic pain after breast cancer surgery (CPBCS) is high in women diagnosed with breast cancer. Similar to other chronic postoperative pain conditions, existing treatments for CPBCS do not always work. Adopting the concept of using pain relieving measures prior to surgery rather than after it, may lead to decreased postoperative pain levels. Soy has been shown to have pain-relieving properties and may reduce the risk for developing chronic post-surgical pain. The purpose of this study is to determine the effects of adding soy protein to the diet before surgery on the development of chronic pain.

Preclinical studies indicate that soy consumption suppresses the development of pain behavior and hyperalgesia following nerve injury. The pain-suppressing properties of soy protein have been shown to be predominately the result of soy pre-operative consumption.

This is a randomized, double blind, placebo-controlled clinical trial for women diagnosed with breast cancer and scheduled to undergo breast cancer surgery. The trial will comprise two phases: 1. A 2-week preoperative dietary manipulation phase, and 2. A one-year postoperative follow up period. In the first phase eligible candidates will undergo a basic dietary evaluation followed by stratification into 4 study groups, based on their pre-vs. postmenopausal status and the planned type of surgery, i.e., formal mastectomy vs. breast-conserving surgery. Women in each group will be randomized to receive either powdered soy protein in the experimental group or milk protein in the control group. During the second, post-surgical phase women will resume their normal diet. If shown to be beneficial, this simple dietary manipulation may prevent one of the most severe sequelae of breast cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease	NCT00031720	Breast Cancer Hot Flashes Hot Flushes	soy protein isoflavones Tamoxifen Placebo	18 Years -	Alliance for Clinical Trials in Oncology
Effects of Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia	NCT05771207	Lung Cancer Sarcopenia	soy protein whey protein placebo	18 Years -	Peking Union Medical College Hospital
The Effect of Soy Protein on Post- Breast Cancer Surgery Pain	NCT01047774	Pain Chronic Disease Breast Cancer	Isolated soy pr... Isolated milk p...	21 Years - 99 Years	McGill University Health Centre/Research Institute of the McGill University Health Centre
The Effect of Soy Protein on Post- Breast Cancer Surgery Pain	NCT01047774	Pain Chronic Disease Breast Cancer	Isolated soy pr... Isolated milk p...	21 Years - 99 Years	McGill University Health Centre/Research Institute of the McGill University Health Centre

Spots Global Cancer Trial Database for soy protein

Every month we try and update this database with for soy protein cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for soy protein

Every month we try and update this database with for soy protein cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for soy protein cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.