Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Bone Density Conservation Agents

Herbal and Botanical

Hormones

Calcium

Caseins

Calcium, Dietary

Soy Bean

Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion.

Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones.

Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.

soy milk

Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.

cow's milk

Lee-Jane W Lu, Ph.D.

Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian hormones and breast density are considered breast cancer risk markers. We propose to test the hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a corresponding reduction in breast density comparing to casein protein.

The aims will be tested by conducting a randomized, double-blind study, with two arms and 100 women in each arm. Premenopausal women will be recruited and randomly allocated to take one of two different dietary supplements daily for 2 years. The two test diets soy protein drink and caseinate protein drink. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary intervention period and analyzed for ovarian hormones. At baseline and after the intervention period, breast density, and bone density will be assessed by radiological techniques at baseline and 1 yr and 2 yr after protein drink supplementation. The efficacy of the dietary intervention will be determined by comparing mean changes of ovarian steroids, and density of the breast and bone tissues over the 2 year dietary intervention period in the two diet groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soya dietary supplements will reduce breast density, which will be explained by individual hormonal changes.

Randomized, double-blind, placebo controlled, 2 parallel groups

Research pharmacist dispensed blinded assigned sachets according to a pre-generated randomization list. Pharmacists were blinded to all other aspects of the research protocols.

Subjects, investigators, research staff, and statisticians were all blinded to treatment assignment.

Only females with regular monthly menstrual cycles, not expecting to become pregnancy, not breast feeding, and not on contraceptives

Soy Protein and Breast Cancer Risk Reduction

Soybean Diet and Breast Density

Will not share as this required financial resources.

Serum will be measured for for blood chemistries , 4 times at baseline, and thereafter at 3-monthly interval for up to 2 years of protein drink supplementation

Serum will be measured for progesterone (ng/ml), 4 times at baseline, and thereafter at 3-monthly interval for up to 2 years of protein drink supplementation

Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.

Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

U.S. Army Medical Research and Development Command

National Center for Research Resources (NCRR)

The University of Texas Medical Branch, Galveston

Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion.

soy milk: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.

Soy Milk

Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with \~1.6 liter of water for ingestion. Casein is free of ovarian hormones.

cow's milk: Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.

Cow's Milk

Total

Ages from 29 to 41

Agesfrom 30 to 41

Age, Customized

Sex: Female, Male

American Indian/Alaskan

Asian

Black/African American

Hispanic or Latino

Other (>2 races)

Caucasian

Race/Ethnicity, Customized

United States

Region of Enrollment

Leejane W. Lu

4 participants images in the cow's milk and 3 images in soy milk were either missing or corrupt.

Mammographic Density (Baseline)

Mammographic Density (1 Year)

Participants completed 2 years of study. 1 image missing from the cow's milk group due to it was corrupt.

Mammographic Density (2 Years)

Fatty Breast Tissue, cc

Glandular Breast Tissue, cc

Total Breast, cc

4 participants images in the cow's milk and 14 images in soy milk were either missing or corrupt.

Breast Tissue Composition Measured by MRI

Blood Will be Measured for Standard Clinical Chemistries

Progesterone (ng/ml)

Percentage of Grandular Tissue in Total Breast Measured by MRI

Baseline

One Year After Diet

Two Years After Diet

Substance Related Disorders

Behaviors and Mental Disorders

Substance-Related Disorders

Tobacco Use Disorder

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Central Nervous System Stimulants

Estrogens

Nicotine

Progesterone

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Participants will start their quit attempts during the mid-follicular phase of their MC (6-8 days post-onset of menses). Each participant will be provided with a range of appropriate dates based on the information about their menstrual cycle, and they will select a target quit date from the range. Participants will be receiving NRT and will have access to behavioral support for the following 6 weeks.

Participants will start their quit attempts during the mid-luteal phase of their MC (6-8 days pre-onset of menses). Each participant will be provided with a range of appropriate dates based on the information about their menstrual cycle, and they will select a target quit date from the range. Participants will be receiving NRT and will have access to behavioral support for the following 6 weeks.

Participants will start their quit attempts within 30 days of their enrollment into the study. They will select their target quit dates without regard for their MC. Participants will be receiving NRT and will have access to behavioral support for the following 6 weeks.

Nicotine replacement therapy and abstinence from smoking are initiated at a specific period with regard to the menstrual cycle.

Timing of nicotine replacement therapy start date

Nicotine patch and a choice of nicotine gum or lozenge (2 mg) for 6 weeks. Participants who smoke 10 or more cigarettes per day receive a package of 21 mg, 14 mg, and 7 mg nicotine patches. For participants who smoke 5-9 (inclusive) cigarettes per day, the package contains 14 mg and 7 mg nicotine patches.

Nicotine Replacement Therapy Agent

Laurie A Zawertailo, PhD

Tina Kabir, BMSc

Laurie Zawertailo

Laurie Zawertailo, PhD

Tobacco use is a risk factor for at least 20 types of cancer and remains the leading preventable cause of cancer in Canada. Smoking cessation is an important cancer prevention strategy for the close to 2 million Canadian women who currently smoke. However, findings from controlled trials and real-world clinical settings indicate that women have greater difficulty achieving abstinence following a quit attempt than men. There is some evidence that hormonal levels and fluctuations throughout the menstrual cycle (MC) may contribute to the greater difficulty women experience when trying to quit smoking. In this study, the start of a quit attempt using nicotine replacement therapy (NRT) will be targeted to specific phases of MC. It was hypothesized that starting a quit attempt during the first half of MC (follicular phase) will result in increased quit success compared to starting during the second half of MC (luteal phase) or the usual practice of not targeting quit start date to MC phase.

Evidence for the influence of the menstrual cycle (MC) phase on smoking cessation outcomes is contradictory and has been limited by small samples and a lack of clarity surrounding ideal quit date timing. Therefore, this large rigorously designed study aims to clarify whether targeting quit date to either the follicular or luteal phase of MC improves quit success. The primary hypothesis states that participants assigned a TQD in the follicular phase of their MC will be more likely to have quit successfully on day 7 of treatment than participants setting their own TQD (usual care). Quit rates at the end of treatment and 6 months post-TQD were identified as secondary objectives.

Participants will enroll in an online smoking cessation program providing nicotine replacement therapy (NRT) and behavioral support. Participants will receive a 6-week supply of NRT consisting of nicotine patch plus their choice of nicotine gum or lozenge, which the participants will be instructed to start on their target quit date (TQD). Eligible individuals will be randomized to a TQD: \[1\] during the mid-luteal phase of their MC (6-8 days pre-onset of menses), \[2\] during the mid-follicular phase of their MC (6-8 days post-onset of menses), or \[3\] within 30 days of enrollment with no regard to MC phase (usual care). Behavioural support will consist of a free downloadable app (My Change Plan) and brief videos delivered via e-mail. These videos will be produced by the CAMH Nicotine Dependence Service and will focus on health behavior change strategies such as building a quit plan, coping with cravings, and relapse prevention.

Smoking Cessation and Menstrual Cycle Phase

Coordinating Smoking Cessation Treatment With Menstrual Cycle Phase to Improve Quit Outcomes: A Randomized Controlled Trial

Proportion of the sample that has been abstinent from smoking for 7 days at the time of assessment (i.e., managed to quit smoking on their target quit date).

Proportion of the sample that has been abstinent from smoking for at least 7 days at the time of assessment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Soy Protein and Breast Cancer Risk Reduction	NCT00204477	Breast Cancer	soy milk cow's milk	30 Years - 40 Years	The University of Texas Medical Branch, Galveston
Smoking Cessation and Menstrual Cycle Phase	NCT05515354	Nicotine Depend... Tobacco Smoking Smoking Cessati... Nicotine Use Di... Substance Use D...	Timing of nicot... Nicotine Replac...	18 Years - 40 Years	Centre for Addiction and Mental Health

Spots Global Cancer Trial Database for ovarian hormones