NCT04890184

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable breast-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

May 8, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

May 5, 2021

Last Update Submit

May 15, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

grape juice

ACTIVE COMPARATOR

100 g of grape juice daily

Dietary Supplement: grape juice

control

PLACEBO COMPARATOR

no dietary intervention

Other: control

Interventions

grape juiceDIETARY_SUPPLEMENT

grape juice

grape juice
controlOTHER

no intervention

control

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with Brest Cancer undergoing adjutant Radiation therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 18, 2021

Study Start

May 8, 2021

Primary Completion

July 1, 2021

Study Completion

July 15, 2021

Last Updated

May 18, 2021

Record last verified: 2021-05