Grape Juice and Dermatitis in Breast Cancer

Breast Cancer Clinical Trial

Official title:

The Effect of Grape Juice Consumption on Radiotherapy-induced Dermatitis in Breast Cancer - A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04890184
• Other study ID #: 1401
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 8, 2021
• Est. completion date: July 15, 2021

Study information

• Verified date: May 2021
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 15, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Dermatitis

Intervention

Dietary Supplement:
• grape juice
grape juice

Other:
• control
no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of dermatitis	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	4 weeks