Investigating the Effect of Oral Whey Protein on Radiation-Induced Dermatitis in Breast Cancer Patients
Design
This double-blind randomized clinical trial will include 100 breast cancer patients undergoing adjuvant radiotherapy at Imam Reza Clinic and Namazi Hospital in Shiraz. Patients will be randomized into intervention and control groups (50 each). The intervention group will receive 30 g/day of whey protein while the control group will receive a matching placebo, from the start to the end of radiotherapy. Radiation-induced dermatitis will be assessed weekly using the EORTC/RTOG criteria.
Settings and conduct
Imam Reza Clinic and Namazi Hospital
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Pathologically confirmed breast cancer; previous breast-conserving surgery and eligibility for adjuvant radiotherapy; absence of systemic or skin diseases affecting wound healing or preventing radiotherapy; no concurrent chemotherapy or trastuzumab, with at least 3 weeks since the last chemotherapy cycle; no systemic corticosteroid use; no lactose intolerance or dairy allergy; and provision of informed consent.
Exclusion Criteria:
Withdrawal from the study; previous breast radiotherapy; development of a medical condition affecting study participation or radiotherapy tolerance; consumption of less than 70% of the prescribed supplement; serious adverse effects related to whey protein; discontinuation of radiotherapy for any reason; diagnosis of metastasis; or requirement for a tumor-bed boost or bolus.
Intervention groups
Whey protein
Main outcome variables
Reduction in the Incidence and Severity of Radiation-Induced Dermatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260807070559N1
Registration date:2026-08-10, 1405/05/19
Registration timing:prospective
Last update:2026-08-10, 1405/05/19
Update count:0
Registration date
2026-08-10, 1405/05/19
Registrant information
Name
Seyede sahar Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 910 710 8271
Email address
s.sahar.hashemi1999@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-23, 1405/06/01
Expected recruitment end date
2028-08-22, 1407/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Oral Whey Protein (Mā’ al-Jubn) on Radiation-Induced Dermatitis in Breast Cancer Patients
Public title
investigating the Effect of Whey Protein on Radiation-Induced Dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pathologically confirmed breast cancer previous breast-conserving surgery, and eligibility for adjuvant radiotherapy
No underlying condition contraindicating radiotherapy
Written informed consent.
No concurrent chemotherapy or trastuzumab (Herceptin)
At least 3 weeks since the last chemotherapy cycle.
Age 18–70 years
No systemic or skin diseases affecting wound healing, such as diabetes mellitus or collagen vascular diseases
No concurrent use of medications affecting wound healing, including systemic corticosteroids
No lactose intolerance or dairy allergy.
Exclusion criteria:
Withdrawal from the study at any stage.
Previous radiotherapy to the breast
Development of a new medical condition affecting wound healing, radiotherapy tolerance, or continued participation
Consumption of less than 70% of the prescribed supplement.
Serious adverse effects related to whey protein.
Need to discontinue radiotherapy for any reason.
Diagnosis of metastasis during the study.
Requirement for a boost or bolus.
Age
From 18 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
A permuted block randomization method with blocks of four will be used. There are six possible permutations for each block of four. Using a random-number table, a randomization list of 100 participants consisting of 25 blocks of four will be generated, determining the allocation sequence for the intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The whey protein supplement and placebo will be prepared in identical containers with respect to appearance, color, size, taste, and packaging, and will be labeled only with codes A and B. Based on the patient’s identification number and the randomization list, the radiation oncology resident will provide the assigned container to the patient. Supplement or placebo administration will begin on the first day of radiotherapy and continue until the last day of treatment.
Patients and study assessors (the radiation oncology resident and specialist) will be blinded to the assigned intervention; therefore, the study will be conducted as a double-blind trial. Group allocation codes will remain confidential until completion of data collection and analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Karimkhanzand
City
Shraz
Province
Fars
Postal code
7134814336
Approval date
2026-08-08, 1405/05/17
Ethics committee reference number
35727
Health conditions studied
1
Description of health condition studied
Radiation-Induced Dermatitis
ICD-10 code
L58
ICD-10 code description
Radiodermatitis
Primary outcomes
1
Description
Reducing the severity of radiation-induced dermatitis
Timepoint
weekly
Method of measurement
Radiation dermatitis will be evaluated weekly by a radiation oncology resident and a radiation oncology specialist, and in case of any disagreement, the specialist's opinion will be recorded as final.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiver of whey protein supplement
Category
Treatment - Other
2
Description
Control group: Oral placebo recipient
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Behnam kadkhodaei
Street address
Karimkhanzand
City
Shiraz
Province
Fars
Postal code
71936-13311
Phone
+98 71 3612 5000
Email
namazee_inf@sums.ac.ir
2
Recruitment center
Name of recruitment center
Emam reza clinic
Full name of responsible person
Behnam kadkhodaei
Street address
Karimkhan zand
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Email
emamreza@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Behnam kadkhodaei
Street address
Karimkhanzand
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3233 2366
Email
President_d@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Behnam Kadkhodaei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Karimkhanzand
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3233 2366
Email
behkad748@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Behnam kadkhodaei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Karimkhanzand
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 917 322 7501
Fax
Email
behkad748@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyede sahar hashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Karimkhanzand
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 910 710 8271
Fax
Email
s.sahar.hashemi1999@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Individual participant data will not be shared because the study data are subject to patient confidentiality and privacy requirements. Only aggregated results will be reported.