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Grape

Participants will be randomized into one of the study drinking sequence groups: white wine followed by white grape juice or white grape juice followed by white wine.

The research study procedures include one screening visit to obtain informed consent, four study visits with blood draws, and ten weekly phone calls and online questionnaires over the ten weeks of the study.

-3 weeks of daily white wine followed by 3 weeks of daily white grape juice

Participants will be randomized into one of the study drinking sequence groups: white grape juice followed by white wine.

The research study procedures include one screening visit to obtain informed consent, four study visits with blood draws, and ten weekly phone calls and online questionnaires over the ten weeks of the study.

- 3 weeks of daily white grape juice followed by 3 weeks of daily white wine

One serving (5 ounces) of white wine daily for 3 weeks

White Wine

One serving (6 ounces) of white grape juice daily for 3 weeks

Grape Juice

Kenneth Mukamal, MD, MPH

This research study is a pilot study, which is the first time investigators are examining the effect of light alcohol consumption on sex hormones among postmenopausal women with estrogen receptor-positive (ER+) breast cancer taking an aromatase inhibitor

The names of the study exposures involved in this study are:

* White wine
* White grape juice

This research study is trying to to help understand whether light alcohol consumption causes short-term changes in the levels of estrogen, progesterone and testosterone, called sex hormones, among postmenopausal women with estrogen and/or progesterone receptor positive breast cancer taking estrogen-blocking medications called aromatase inhibitors.

The research study procedures include one screening visit to obtain informed consent, four study visits with blood draws, and ten weekly phone calls and online questionnaires over the ten weeks of the study.

This research study involves 10 weeks of participation, including 3 weeks consuming one serving of white wine daily, 3 weeks consuming one serving of white grape juice daily, and 2 weeks of drinking neither alcohol nor grape juice before each of these 3-week drinking periods.

In this experimental study, participants will be asked to drink white wine and white grape juice, which are not consumed as the standard of care. The U.S. Food and Drug Administration (FDA) has not approved alcohol as a treatment for any disease.

It is expected that about 20 women will take part in this research study.

Alcohol and Breast Cancer (ABC) Trial

Effect of Light Alcohol Intake on Sex Hormone Levels Among Postmenopausal Women With ER+ Breast Cancer on Aromatase Inhibitor Therapy: The Alcohol and Breast Cancer (ABC) Trial

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Principal Investigator

Symptoms and General Pathology

Anorexia

Patients consume white wine twice daily for 3-4 weeks.

Patients receive an oral non-wine nutritional supplement (e.g., Boost or Ensure) twice daily for 3-4 weeks.

therapeutic nutritional supplementation

white wine

questionnaire administration

Aminah Jatoi, M.D.

Tom R. Fitch, M.D.

Amber L. Isley, M.D.

RATIONALE: It is not yet know whether white wine is more effective than a nutritional supplement in improving appetite.

PURPOSE: This randomized clinical trial is studying white wine to see how well it works compared with a nutritional supplement in improving appetite in patients with cancer

OBJECTIVES:

I. To compare white wine (Arm A) to non-wine nutritional supplement (Arm B) for the treatment of cancer-associated anorexia.

II. To evaluate the side effect profile of white wine (Arm A).

OUTLINE: Patients are stratified according to primary malignant disease (lung vs gastrointestinal vs other \[specify\]), severity of weight loss (excluding peri-operative weight loss) within the past 2 months (\< 4.6 kg \[\< 10 lbs\] vs \>= 4.6 kg \[\>= 10 lbs\]), age (\< 50 years vs \>= 50 years), and planned concurrent chemotherapy or radiation (yes vs no).

Patients are randomized to 1 of 2 arms.

ARM A: Patients consume white wine with =\< 15% alcohol content twice daily for 3-4 weeks.

ARM B: Patients receive an oral non-wine nutritional supplement (e.g., Boost or Ensure) twice daily for 3-4 weeks.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Alcohol and Breast Cancer (ABC) Trial	NCT05423730	ER+ Breast Canc... Breast Cancer Aromatase Inhib...	White Wine Grape Juice	21 Years - 90 Years	Beth Israel Deaconess Medical Center
White Wine or Nutritional Supplement in Improving Appetite in Patients With Cancer	NCT00936728	Unspecified Adu...	therapeutic nut... white wine questionnaire a...	21 Years -	Academic and Community Cancer Research United

Spots Global Cancer Trial Database for white wine

Every month we try and update this database with for white wine 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 white wine

Every month we try and update this database with for white wine 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 white wine 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.