| CTRI Number |
CTRI/2024/03/064558 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Supervision of exercises for improving compliance and reducing the side effects of prostate cancer treatment |
|
Scientific Title of Study
|
Optimising adHERence with A Customised flexibLE multimodal exerciSe regimen in prostate cancer patients on radiation and androgen deprivation therapy - a substudy of HERACLES on adherence |
| Trial Acronym |
(HERACLES-A) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishnu Ravindran P |
| Designation |
DNB Radiation Oncology resident |
| Affiliation |
Tata medical center,kolkata |
| Address |
Tata medical center,14, MAR(E W), DH Block(Newtown), Action Area I, Newtown, Kolkata, Chakpachuria, West Bengal
Kolkata
WEST BENGAL
700160
India |
| Phone |
8818926399 |
| Fax |
|
| Email |
vishnu.ravindranp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Moses Arunsingh |
| Designation |
Consultant, Dept. of Radiation Oncology, |
| Affiliation |
Tata medical center,kolkata |
| Address |
Tata Medical Center,,14, MAR(E W), DH Block(Newtown), Action Area I,Newtown, Kolkata, Chakpachuria, West Bengal
Kolkata
WEST BENGAL
700160
India |
| Phone |
9007395797 |
| Fax |
|
| Email |
85moses@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tata medical center kolkata |
| Designation |
Consultant, Dept. of Radiation Oncology, |
| Affiliation |
Tata medical center,kolkata |
| Address |
Tata Medical Center,,14, MAR(E-W), DH Block(Newtown), Action Area I, Newtown, Kolkata, Chakpachuria, West Bengal
Kolkata
WEST BENGAL
700160
India |
| Phone |
9007395797 |
| Fax |
|
| Email |
85moses@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Medical Center, 14, Major Arterial Road (EW), New Town, Rajarhat, Kolkata |
|
|
Primary Sponsor
|
| Name |
Tata medical center |
| Address |
,14, MAR(E W), DH Block(Newtown), Action Area I, Newtown, Kolkata, Chakpachuria, West Bengal |
| 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 Vishnu Ravindran |
Tata medical center |
Consultation Room 1, Department of Radiation Oncology, (Basement of Phase 2 Building), Tata Medical Center, 14, Major Arterial Road (EW), New Town, Rajarhat, Kolkata
Kolkata
WEST BENGAL |
03366057000
vishnu.ravindranp@tmckolkata.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Tata Medical Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C61||Malignant neoplasm of prostate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A semi-supervised flexible multimodal exercise regimen |
The patients randomised to the study arm will meet with the physiotherapy team for advice regarding exercise regimen to be followed by them. These patients will then be provided with a prescription which will detail the customised set of exercises which will have to be done by the patient. It will be taught to them by the physiotherapist. The prescription will have details on the duration and number of repetitions of each exercise to be done by the patient. The study arm patients will have multiple visits with the physiotherapy team for supervised exercise sessions. These sessions will happen according to the following time periods: First visit to the physiotherapy team on the day of consenting, on the day of the planning CT scan, once a week during the radiation therapy (4 visits), on the days of review with the oncologist in the clinic once in 3 months after RT. During these visits, the exercise regimen can be tweaked according to the patient’s feedback by the physiotherapy team. An attendant who lives with the patient will also be taught the exercises during the first session and how to assist the patient in carrying them out. The attendant will then act as an accountability partner who will then be asked to encourage the patient to adhere to the exercises at home. The intervention will last for a duration of 6 months. |
| Comparator Agent |
Unsupervised exercise regimen guided by literature and an one-off instruction session on the exercise regimen |
The patients randomised to the standard arm will meet with the physiotherapy team for advice regarding exercise regimen to be followed by them. These patients will then be provided with a prescription which will detail the standard set of exercises which will have to be done by them. It will be taught to them by the physiotherapist. The prescription will have details on the duration and number of repetitions of each exercise to be done by the patient. Exercises will continue for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
Participants must have all of the following:
1 Confirmed prostatic carcinoma
2 Will undergo radiation therapy - radical
3 radiation therapy or prostate directed radiation therapy
4 Is on androgen deprivation therapy with either medical or surgical methods and is planned to be on this for a minimum duration of 6 months
5 ECOG Performance status 0-1
6 Signed study specific consent form
7 Patient willing and reliable for follow-up
|
|
| ExclusionCriteria |
| Details |
1.ECOG Performance status 2 or more
2.Limitation in mobility and/or comorbidities that will prevent them from complying to exercise requirements
3.Unable to follow up or poor logistic or social support
4.Deemed to be at high risk of harm due to the presence of lytic bone metastases
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess whether the prescription of an exercise regimen as part of the treatment and offering a semi-supervised flexible multimodal exercise regimen to prostate cancer patients undergoing androgen deprivation therapy and radiation therapy results in better adherence to the exercise regimen at 24 weeks from the start of androgen deprivation therapy taking adherence as 85 %o fthe prescribed exercises
|
at 12 weeks and 24 weeks and 36 week after start of androgen depravation therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess whether the prescription of an exercise regimen as part of the treatment and offering a semi-supervised flexible multimodal exercise regimen to prostate cancer patients undergoing androgen deprivation therapy and radiation therapy results in better adherence to the exercise regimen at 24 weeks from the start of androgen deprivation therapy.
|
at 12 weeks and 24 weeks after start of androgen depravation therapy. |
|
|
Target Sample Size
|
Total Sample Size="83"
Sample Size from India="83"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
PROTOCOL TITLE | Optimising adHERence with A Customised flexibLE multimodal exerciSe regimen in prostate cancer patients on radiation and androgen deprivation therapy - (HERACLES) | RATIONALE | A semi-supervised and a flexible personalised prescription of an exercise regimen is likely to improve adherence and consequently improve the quality of life of the prostate cancer patients undergoing androgen deprivation therapy in addition to radiation therapy. | AIM | Evaluate the effectiveness of incorporation of exercise into the treatment and offering a semi-supervised multimodal exercise regimen in improving exercise adherence of prostate cancer patients undergoing ADT and radiation therapy. | PRIMARY STUDY OBJECTIVES | To assess whether the prescription of an exercise regimen as part of the treatment and offering a semi-supervised flexible multimodal exercise regimen to prostate cancer patients undergoing androgen deprivation therapy and radiation therapy results in better adherence to the exercise regimen at 24 weeks from the start of androgen deprivation therapy. | STUDY DESIGN | This will be a two-arm prospective randomised controlled, open-label, parallel-group, superiority trial. | TRIAL POPULATION | Inclusion criteria Participants must have all of the following: Confirmed prostatic carcinoma Will undergo radiation therapy - radical radiation therapy or prostate directed radiation therapy Is on androgen deprivation therapy with either medical or surgical methods and is planned to be on this for a minimum duration of 6 months ECOG Performance status 0-1 Signed study specific consent form Patient willing and reliable for follow-up
Exclusion criteria Patients should have none of the following ECOG Performance status 2 or more Limitation in mobility and/or comorbidities that will prevent them from complying to exercise requirements Unable to follow up or poor logistic or social support Deemed to be at high risk of harm due to the presence of lytic bone metastases.
| TREATMENT REGIMEN | ARM 1 (Control Arm): Unsupervised exercise regimen guided by literature and an one-off instruction session on the exercise regimen
ARM 2 (Experimental Arm): A semi-supervised flexible multimodal exercise regimen | RECRUITMENT TARGET | The trial will recruit 83 patients. | PRIMARY ENDPOINT
| Adherence to the prescribed exercise protocol at 24 weeks: A compliance of performing 85% of the exercises required for the week will be considered as adherence for that week. This will be measured using the log maintained by the trial participants and calculating the adherence against the prescribed exercise regimen.
| KEY SECONDARY ENDPOINTS
| Changes in the Quality of Life as measured by FACT-F, FACT-G and EORTC - PR25 measured at baseline, at 12 weeks and at 24 weeks Functional performance of the patients at baseline, at 12 weeks and at 24 weeks Body Composition of the patients at baseline, at 12 weeks and at 24 weeks
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