Grape Juice and Dermatitis in Breast Cancer

May 15, 2021 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: grape juice
100 g of grape juice daily
Dietary supplement: grape juice
grape juice
Placebo Comparator: control
no dietary intervention
Other: control
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 8, 2021

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 15, 2021

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 15, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 15, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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