To evaluate if the application of platelet rich plasma on the skin in the radiation site, during radiation treatment will reduce radiation induced skin reactions in patients of head and neck and breast cancer receiving radiotherapy.

Comparison of best supportive care with or without topical autologous platelet rich plasma as a prophylactic agent for reducing acute radiation dermatitis: a randomized controlled study. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065327

Enrollment

120

Registered

2024-04-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 2: C50-C50- Malignant neoplasms of breast

Interventions

Intervention1: Topical application of platelet rich plasma on the radiation treatment site.: The platelet rich plasma (PRP) for topical application will be derived from the patient themselves. Prior

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years of age. 2. Patients of ECOG performance status 0-2 3. Patients with biopsy proven squamous cell carcinoma of the head and neck, receiving curative radiation with or without concurrent chemotherapy in the definitive or adjuvant setting. 4. Patients with biopsy proven adenocarcinoma of the breast, post-surgical resection (either breast conservative surgery or modified radical mastectomy) who are receiving curative radiation in the adjuvant setting.

Exclusion criteria

Exclusion criteria: 1. Patients receiving palliative radiation 2. Patients with prior history of radiation to the head and neck or breast 3. Patients with tumor involving the skin 4. Patients with rash, ulceration or open wounds in the treatment field. 5. Patients too sick to withstand a blood withdrawal of more than 100 ml e.g., those with multiple comorbidities like cardiac diseases, respiratory diseases etc (to be decided by the clinical judgment of the physician in the Blood bank/ Transfusion medicine center )

Design outcomes

Primary

Measure	Time frame
To determine if the proportion of patients developing acute radiation dermatitis of Radiation Therapy Oncology Group (RTOG) grade 2 and above is lesser in the platelet rich plasma arm as compared to the standard treatment arm in patients undergoing radiation therapy for head and neck and breast cancer.Timepoint: Weekly during the course of radiation treatment and 3 months after the completion of radiation treatment.	—

Measure

Time frame

To determine if the proportion of patients developing acute radiation dermatitis of Radiation Therapy Oncology Group (RTOG) grade 2 and above is lesser in the platelet rich plasma arm as compared to the standard treatment arm in patients undergoing radiation therapy for head and neck and breast cancer.Timepoint: Weekly during the course of radiation treatment and 3 months after the completion of radiation treatment.

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Secondary

Measure	Time frame
To compare the locoregional control assessed with complete response of the primary and regional nodes at 3 months in both the arms. This will be done by a CECT scan in head and neck cancer patients using the RECIST (Response Evaluation Criteria In Solid Tumors) criteria and by clinical examination in breast cancer patients.Timepoint: 3 months after the completion of radiation treatment.;To determine if the proportion of patients developing clinically significant acute radiation dermatitis of RTOG grade 3 and above is lesser in the PRP arm as compared to the standard treatment arm.Timepoint: Weekly during the course of radiation treatment and 3 months after the completion of radiation treatment.;To determine if the time taken to develop Radiation Therapy Oncology Group (RTOG) grade 2,3 or 4 dermatitis is more in the PRP arm as compared to the standard treatment arm.Timepoint: Weekly during the course of radiation treatment and 3 months after the completion of radiation treatment.	—

Measure

Time frame

To compare the locoregional control assessed with complete response of the primary and regional nodes at 3 months in both the arms. This will be done by a CECT scan in head and neck cancer patients using the RECIST (Response Evaluation Criteria In Solid Tumors) criteria and by clinical examination in breast cancer patients.Timepoint: 3 months after the completion of radiation treatment.;To determine if the proportion of patients developing clinically significant acute radiation dermatitis of RTOG grade 3 and above is lesser in the PRP arm as compared to the standard treatment arm.Timepoint: Weekly during the course of radiation treatment and 3 months after the completion of radiation treatment.;To determine if the time taken to develop Radiation Therapy Oncology Group (RTOG) grade 2,3 or 4 dermatitis is more in the PRP arm as compared to the standard treatment arm.Timepoint: Weekly during the course of radiation treatment and 3 months after the completion of radiation treatment.

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Countries

India

Contacts

Public ContactDr Shyama Prem S

Jawaharlal Institute of Post Graduate Medical Education and Research, JIPMER

shyamaprems1@gmail.com9787814215

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026