| CTRI Number |
CTRI/2018/10/015927 [Registered on: 08/10/2018] Trial Registered Prospectively |
| Last Modified On: |
05/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Other |
|
Public Title of Study
|
A study to identify the effect of foot massage in reducing nausea and vomiting among newly diagnosed patients undergoing chemotherapy in RCC, JIPMER. |
|
Scientific Title of Study
|
Effect of foot massage on patients with chemotherapy induced nausea and vomiting (CINV) in RCC, JIPMER. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Cluny Asha |
| Designation |
MSc. Nursing |
| Affiliation |
Jawaharlal Istitute of Post graduate Medical Education & Research |
| Address |
Room No.: 348, nightingale house, college of nursing, JIPMER, Dhanvanthri nagar, gorimedu, Puducherry-06.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8940517045 |
| Fax |
|
| Email |
ashaashokan93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MJKumari |
| Designation |
Professor Cum Principal (Ag.) & Vice-Principal |
| Affiliation |
Jawaharlal Istitute of Post graduate Medical Education & Research |
| Address |
Professor Cum Principal (Ag.) & Vice-Principal, College of Nursing, JIPMER.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894595420 |
| Fax |
|
| Email |
kumari_mj@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Cluny Asha |
| Designation |
MSc. Nursing |
| Affiliation |
Jawaharlal Istitute of Post graduate Medical Education & Research |
| Address |
Room No.: 348, nightingale house, college of nursing, JIPMER, Dhanvanthri nagar, gorimedu, Puducherry-06.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8940517045 |
| Fax |
|
| Email |
ashaashokan93@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Cluny Asha |
| Address |
Room no-348 Nightingale House College of Nursing Dhanvanthri Nagar JIPMER Puducherry-06 |
| 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 |
| Cluny Asha |
JIPMER. Puducherry-06 |
Regional Cancer Center, Ground floor- Day care. Medical Oncology
Pondicherry
PONDICHERRY |
8940517045
0413-2272066
ashaashokan93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ehical Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D098||Carcinoma in situ of other specified sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Foot Massage group |
foot massage is given 20 minutes before starting the chemotheray, 20minutes after starting chemotherapy and 20 minutes after completion of chemotherapy (10 minutes for each leg). Total duration of therapy is 60 minutes.
Pretest and posttest will be done |
| Comparator Agent |
routine care group |
Pretest and posttest will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed cancer patients who are all undergoing highly emetogenic chemotherapy in RCC, JIPMER
Patients who are more than 18 years of age and less than 70 years of age in both gender
patients who are conscious and able to communicate. |
|
| ExclusionCriteria |
| Details |
Patients who have vomiting prior to chemotherapy
patients having any neuromuscular problems of the lower extremities
patients with esophageal and stomach malignancis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| patients will have reduction in nausea, vomiting and retching during chemotheray after the foot massage |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
15/10/2018 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomize control trial, to assess the effectiveness of foot massage on reducing nausea and vomiting among newly diagnosed cancer patients undergoing highly emetogenic chemotherapy. Pretest wll be done prior to chemotherapy and post test will be done after 48 hours of undergoing chemotherapy with the help of Rhodes indexof nausea, vomiting and retching scale. Patients will have reduction in nausea and vomiting after getting chemotherapy after foot massage.
|