Grape Juice and Dermatitis in Breast Cancer

NCT ID: NCT04890184

Last Updated: 2021-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-08

Study Completion Date

2021-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aimed to investigate the effect of grape juice on acute radiation dermatitis in breast cancer (BC) patients undergoing radiotherapy (RT). 50 eligible BC patients will randomly assign to consume 100 gr of grape juice per day during and 1 week after RT or with no intervention (control group). The radiation dermatitis will be assessed weekly according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/EORTC) scales.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Dietary intake of patients will be examined by expert dietitians at baseline and end of RT using the average of three-day 24-hour recalls. Weight (kg), body fat percentage, skeletal muscle percentage and visceral fat level will be measured using the OMRON Body Composition Monitor and Scale.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

grape juice

100 g of grape juice daily

Group Type ACTIVE_COMPARATOR

grape juice

Intervention Type DIETARY_SUPPLEMENT

grape juice

control

no dietary intervention

Group Type PLACEBO_COMPARATOR

control

Intervention Type OTHER

no intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

grape juice

grape juice

Intervention Type DIETARY_SUPPLEMENT

control

no intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* women with Brest Cancer undergoing adjutant Radiation therapy

Exclusion Criteria

* previous history of RT, MRM,
* concomitant presence of two or more malignant tumors
* metastasis to other areas
* allergy or intolerance to tahini
* skin diseases and wounds
* severe liver and renal disease
* autoimmune diseases
* pregnant and lactating women
* those who treated with hypo fraction RT
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Azita Hekmatdoost

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1401

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Aloe Vera on Irradiated Breast Tissue
NCT01824134 COMPLETED PHASE3