Grape Juice and Dermatitis in Breast Cancer

National Nutrition and Food Technology Institute

Status: Unknown

Conditions: Breast Cancer

Treatments: Dietary Supplement: grape juice; Other: control

Study type: Interventional

Funder types: Other

Identifiers

NCT04890184

1401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

grape juice

Active Comparator group

Description:

100 g of grape juice daily

Treatment:

Dietary Supplement: grape juice

control

Placebo Comparator group

Description:

no dietary intervention

Treatment:

Other: control