| CTRI Number |
CTRI/2023/08/056465 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
24/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of skin related adverse effects of chemotherapy drugs and radiotherapy in cancer patients |
|
Scientific Title of Study
|
Study of mucocutaneous adverse effects of chemotherapeutic drugs and radiotherapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaveri Rusia |
| Designation |
Junior Resident |
| Affiliation |
DMIHER, Department of dermatology , Sawangi, Meghe |
| Address |
DMIHER , paloti road , Department of dermatology,sawangi , wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
08889889814 |
| Fax |
|
| Email |
kaverirusia12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhushan Madke |
| Designation |
Professor and Head of Department |
| Affiliation |
DMIHER, Department of dermatology , Sawangi, Meghe |
| Address |
DMIHER DU , paloti road , Department of dermatology,sawangi , wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7066887353 |
| Fax |
|
| Email |
drbhushan81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaveri Rusia |
| Designation |
Junior Resident |
| Affiliation |
DMIHER, Department of dermatology , Sawangi, Meghe |
| Address |
DMHIER DU , paloti road , Department of Dermatology,sawangi , wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
08889889814 |
| Fax |
|
| Email |
kaverirusia12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, AVBRH Hospital, sawangi, Wardha |
|
|
Primary Sponsor
|
| Name |
- |
| Address |
- |
| Type of Sponsor |
Other [-] |
|
|
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 |
| kaveri rusia |
Siddharth Gupta Memorial Cancer Hospital or Acharya Vinoba Bhave Rural Hospital, Sawangi |
DMIHER DU , paloti road, Department of Dermatology, sawangi ,wardha
Wardha
MAHARASHTRA |
08889889814
kaverirusia12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L599||Disorder of the skin and subcutaneous tissue related to radiation, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
Patients receiving chemotherapy and radiotherapy irrespective of their age and sex.
Patients willing to participate.
|
|
| ExclusionCriteria |
| Details |
Patient with mucocutaneous manifestation due to malignancy.
Known Prior primary dermatoses.
Drug reaction due to Non-Chemotherapeutic Drugs.
Mucocutaneous manifestation of Paraneoplastic syndromes.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the various mucocutaneous manifestations in patients with solid organ malignancy or haematological malignancy receiving chemotherapy and radiotherapy. |
1 year 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To find out the frequency of mucocutaneous manifestation in patient receiving chemotherapy.
•To find out the frequency of mucocutaneous manifestation in patient receiving radiotherapy.
•To know the various pattern of mucocutaneous involvement in chemotherapy.
•To know the various pattern of mucocutaneous involvement in radiotherapy.
•To assess the severity of mucocutaneous involvement with the chemotherapeutic drugs.
|
1 year 2 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2023 |
| 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="1"
Months="2"
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
|
There is an enormous advancement of chemotherapeutic drugs and in radiotherapy. With the advancement the adverse effects in patient receiving chemotherapeutic drugs and radiotherapy have also increased. Hence identifying and treating adverse effects of chemotherapeutic drugs and radiotherapy is utmost important for patients. This will be an observational prospective study that will be conducted in a tertiary care cancer hospital [Siddharth Gupta Memorial Cancer hospital] and patients coming to OPD of AVBRH in Department of Dermatology over a period of 1.5 years who will be presenting with the mucocutaneous adverse effects. Detailed History and Cutaneous examination will be performed and graded according to Common Terminology Criteria for Adverse Events v5. The various mucocutaneous adverse effects will be compiled and grading will be done. This study will help us to find out the various mucocutaneous adverse effects associated with various new chemotherapeutic drugs and radiation. |