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.
- Conditions
- Health Condition 1: C50-C50- Malignant neoplasms of breastHealth Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2024/04/065327
- Lead Sponsor
- Dr. Ebenezer Staines
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 )
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.