| CTRI Number |
CTRI/2024/04/065327 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JIP/IEC/2024/01/11 Version: 1.1 Date: 05/03/24 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ebenezer Staines |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research, JIPMER |
| Address |
Department of Radiation Oncology,
Regional Cancer Centre RCC,
JIPMER,
Dhanvantri Nagar,
Gorimedu,
Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843312378 |
| Fax |
|
| Email |
eby23staines@gmail.com; jr8129@jipmer.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyama Prem S |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research, JIPMER |
| Address |
Department of Radiation Oncology,
Regional Cancer Centre RCC,
JIPMER,
Dhanvantri Nagar,
Gorimedu,
Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9787814215 |
| Fax |
|
| Email |
shyamaprems1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyama Prem S |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research, JIPMER |
| Address |
Department of Radiation Oncology,
Regional Cancer Centre RCC,
JIPMER,
Dhanvantri Nagar,
Gorimedu,
Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9787814215 |
| Fax |
|
| Email |
shyamaprems1@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Intramural Research Fund |
|
|
Primary Sponsor
|
| Name |
Dr. Ebenezer Staines |
| Address |
Department of Radiation Oncology,
Regional Cancer Centre RCC,
JIPMER,
Dhanvantri Nagar,
Gorimedu,
Pondicherry.
605006. |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ebenezer Staines |
Regional Cancer Centre, JIPMER. |
Department of Radiation Oncology,
Regional Cancer Centre RCC, JIPMER,
Dhanvantri Nagar,
Gorimedu,
Pondicherry.
Pondicherry
PONDICHERRY |
9843312378
eby23staines@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (2) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Best supportive care as per institutional protocol. |
Patients in the control arm will also be monitored for the development of radiation dermatitis. They will be offered the institutional standard protocol measures for the management of radiation dermatitis. |
| Intervention |
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 to the start of radiation treatment, those patients in the intervention arm will be called to the JIPMER transfusion medicine department where around 100 to 125 ml of platelet rich plasma will be collected from the patient, in a sterile manner under strict aseptic precautions and aliquoted into 3 or 5 ml sterile screw capped containers (3 ml containers for head and neck cancer patients and 5 ml containers for breast cancer patients). The containers will then be stored at minus 18 degree Celsius in the JIPMER Transfusion medicine department refrigerator.
Following radiation treatment for the day, the patient will be directed to the transfusion medicine department where 1 aliquot of the PRP will be handed to them. The PRP will then be mixed with neutral paraffin cream to obtain an ointment like consistency which will be applied at the radiation treatment site. The initial few applications will be done by the primary investigator and subsequently the patient themselves will be taught how to apply it. The topical application of PRP for patients in the intervention arm will be done throughout the radiation treatment course, only on the days they receive radiation. No further topical application of PRP will be done once the patient completes their radiation treatment course. The patient will be monitored every week during their treatment course for the development of radiation dermatitis. In addition to PRP, they will also be offered the institutional standard protocol measures for the management of radiation dermatitis. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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 ) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
Weekly during the course of radiation treatment and 3 months after the completion of radiation treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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. |
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. |
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. |
Weekly during the course of radiation treatment and 3 months after the completion of radiation treatment. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
More than 90% of head and neck and breast cancer patients require radiotherapy either in the definitive, adjuvant or palliative setting. Radiation dermatitis leads to significant distress to the patient due to the pain and burning sensation and can greatly impair the patient’s quality of life. It may further get complicated by superadded infections on the raw surface and can quickly turn into sepsis due to the breach of the protective barrier of the skin. In severe cases it can also result in interruptions to treatment and prolongation of treatment time which can have detrimental effects on the local control of the disease and can affect the treatment outcomes. There is currently no literature available on the prophylactic potential of autologous platelet-rich plasma in reducing the incidence of acute radiation dermatitis in patients with head and neck and breast cancer. This study aims to address this gap in the body of evidence and contribute to our understanding of this topic. This study may provide a safe, cost-effective solution to reduce radiation dermatitis in head and neck and breast cancer patients, while also advancing our knowledge of the role of autologous platelet-rich plasma in mitigating radiation-induced complications, guiding further research possibilities. |