Grape Juice and Dermatitis in Breast Cancer | NCT04890184

Studies
Grape Juice and Dermatitis in Breast Cancer

NCT04890184

Sponsor

National Nutrition and Food Technology Institute

Status

Unknown status

Last Update Posted

May 18, 2021Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

grape juice
control

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 8, 2021Estimated

Primary Completion Date

Jul 1, 2021Estimated

Completion Date

Jul 15, 2021Estimated

First Submitted Date

May 5, 2021

First Submission Date that Met QC Criteria

May 15, 2021

First Posted Date

May 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2021

Last Update Posted Date

May 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Azita Hekmatdoost, professor, National Nutrition and Food Technology InstitutePrincipal Investigator

Lead Sponsor

National Nutrition and Food Technology InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
grape juice	Active Comparator	100 g of grape juice daily	Dietary Supplement: grape juice
control	Placebo Comparator	no dietary intervention	Other: control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
grape juice	Dietary Supplement	grape juice	grape juice
control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided