The effect of oral zinc sulfate on radiotherapy-induced acute dermatitis in breast cancer

The effects of oral zinc sulfate on prevention and treatment of radiation induced acute dermatitis in patients with breast cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200621047857N1

Enrollment

150

Registered

2021-08-26

Start date

2021-05-10

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute dermatitis to breast cancer radiation therapy. Radiodermatitis

Interventions

Intervention 1: Intervention group: This group will be treated daily with a dose of 220 mg of zinc sulfate (containing pharmacy) equivalent to 50 mg of elemental zinc, 3 times a day every 8 hours (tot

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with non-inflammatory breast cancer Undergone surgery and chemotherapy Candidates for whole breast radiotherapy

Exclusion criteria

Exclusion criteria: Dissatisfaction with participating in the study Existence of contraindications to radiation therapy

Design outcomes

Primary

Measure	Time frame
Degree of dermatitis. Timepoint: In the first treatment session and weekly after every 5 sessions and then at the end of treatment sessions and then 1 month and then 3 months after radiotherapy. Method of measurement: The dermatitis grade will be based on the following RTOG criteria: Grade 1: Erythema and brief reddening and follicular or fading of the skin, dry scaling of the skin, reduction of skin perspiration Grade 2: Painful or glowing erythema of the skin, patchy scaling Wet, brief skin edema Grade 3: Wet scaling of the skin in areas other than skin folds, skin edema Grade 4: Wounds, necrosis, bleeding at each visit / burn site (supraclavicular, axilla, submamillaria, internal Mammillaria) / Cases in which dermatitis leads to discontinuation of treatment or pain resulting from drug use.;Need for narcotic. Timepoint: In the first treatment session and weekly after every 5 sessions and then at the end of treatment sessions and then 1 month and then 3 months after radiotherapy. Method of measurement: Frequent need for analgesia.	—

Measure

Time frame

Degree of dermatitis. Timepoint: In the first treatment session and weekly after every 5 sessions and then at the end of treatment sessions and then 1 month and then 3 months after radiotherapy. Method of measurement: The dermatitis grade will be based on the following RTOG criteria: Grade 1: Erythema and brief reddening and follicular or fading of the skin, dry scaling of the skin, reduction of skin perspiration Grade 2: Painful or glowing erythema of the skin, patchy scaling Wet, brief skin edema Grade 3: Wet scaling of the skin in areas other than skin folds, skin edema Grade 4: Wounds, necrosis, bleeding at each visit / burn site (supraclavicular, axilla, submamillaria, internal Mammillaria) / Cases in which dermatitis leads to discontinuation of treatment or pain resulting from drug use.;Need for narcotic. Timepoint: In the first treatment session and weekly after every 5 sessions and then at the end of treatment sessions and then 1 month and then 3 months after radiotherapy. Method of measurement: Frequent need for analgesia.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoumeh Nouri

Kerman University of Medical Sciences

nourim861@gmail.com0098343327236

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026