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NCT04890197 Clinical Trial

Tahini and Dermatitis in Breast Cancer

Breast Cancer Clinical Trial

Official title:
The Effects of Tahini Consumption on Radiotherapy Induced Dermatitis in Breast Cancer - A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04890197
Other study ID # 1400
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to investigate the effect of tahini on acute radiation dermatitis in breast cancer (BC) patients undergoing radiotherapy (RT). 50 eligible BC patients will randomly assign to consume tahini 48 gr 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.

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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• tahini
48 grams tahini
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
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