Grape Juice and Dermatitis in Breast Cancer

Not Applicable

• Conditions: Breast Cancer
• Interventions: Other: control; Dietary Supplement: grape juice

• Registration Number: NCT04890184
• Lead Sponsor: National Nutrition and Food Technology Institute

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-05
• Study Start: 2021-05-08
• Study First Submitted QC: 2021-05-15
• Last Update Submitted: 2021-05-15
• Study First Posted: 2021-05-18
• Last Update Posted: 2021-05-18
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	no dietary intervention
grape juice	grape juice	100 g of grape juice daily

Primary Outcome Measures

Name	Time	Method
severity of dermatitis	4 weeks	Change from Baseline severity at 4 weeks. The radiation dermatitis will be assessed according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/EORTC) scales