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Grape Juice and Dermatitis in Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
grape juice
control
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    grape juice

    control

    Arm Description

    100 g of grape juice daily

    no dietary intervention

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 5, 2021
    Last Updated
    May 15, 2021
    Sponsor
    National Nutrition and Food Technology Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04890184
    Brief Title
    Grape Juice and Dermatitis in Breast Cancer
    Official Title
    The Effect of Grape Juice Consumption on Radiotherapy-induced Dermatitis in Breast Cancer - A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 8, 2021 (Anticipated)
    Primary Completion Date
    July 1, 2021 (Anticipated)
    Study Completion Date
    July 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Nutrition and Food Technology Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    grape juice
    Arm Type
    Active Comparator
    Arm Description
    100 g of grape juice daily
    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Description
    no dietary intervention
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    grape juice
    Intervention Description
    grape juice
    Intervention Type
    Other
    Intervention Name(s)
    control
    Intervention Description
    no intervention
    Primary Outcome Measure Information:
    Title
    severity of dermatitis
    Description
    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
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Grape Juice and Dermatitis in Breast Cancer

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