The Effect of Grape Juice Consumption on Radiotherapy-induced Dermatitis in Breast Cancer - A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Primary Endpoint
- severity of dermatitis
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
severity of dermatitis
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Azita Hekmatdoost
professor
National Nutrition and Food Technology Institute