| CTRI Number |
CTRI/2024/03/064573 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Additional supervision of prescribed exercise regimen] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Supervised exercises for 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 |
| Trial Acronym |
HERACLES |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Moses Arunsingh |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Consultation Room 1, Department of Radiation Oncology, (Basement of Phase 2 Building), Tata Medical Center, 14, Major Arterial Road (EW), New Town, Rajarhat, Kolkata
North Twentyfour Parganas
WEST BENGAL
700160
India |
| Phone |
03366057000 |
| Fax |
|
| Email |
moses.arunsingh@tmckolkata.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Moses Arunsingh |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Consultation Room 1, Department of Radiation Oncology, (Basement of Phase 2 Building), Tata Medical Center, 14, Major Arterial Road (EW), New Town, Rajarhat, Kolkata
North Twentyfour Parganas
WEST BENGAL
700160
India |
| Phone |
03366057000 |
| Fax |
|
| Email |
moses.arunsingh@tmckolkata.com |
|
Details of Contact Person
Public Query
|
| Name |
Moses Arunsingh |
| Designation |
Consultant |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Consultation Room 1, Department of Radiation Oncology, (Basement of Phase 2 Building), Tata Medical Center, 14, Major Arterial Road (EW), New Town, Rajarhat, Kolkata
North Twentyfour Parganas
WEST BENGAL
700160
India |
| Phone |
03366057000 |
| Fax |
|
| Email |
moses.arunsingh@tmckolkata.com |
|
|
Source of Monetary or Material Support
|
| Tata Medical Center, Kolkata |
|
|
Primary Sponsor
|
| Name |
Tata Medical Center |
| Address |
14, Major Arterial Road (EW), New Town, Rajarhat, Kolkata |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Moses Arunsingh |
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
North Twentyfour Parganas
WEST BENGAL |
03366057000
moses.arunsingh@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 the exercise regimen to be followed by them. These patients will then be provided with a prescription that details the customised set of exercises that will have to be done by the patient. The physiotherapist will teach them this. 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. 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 and be asked to encourage the patient to adhere to the exercises at home.
Total Duration of the intervention: 6 months
Frequency of the intervention:
1st intervention: On the day of consenting (Week 1)
2nd intervention: On the day of the planning CT scan (Week 6-8) 3rd to 6th intervention: Once a week during the radiation therapy (Week 13,14,15,16)
7th intervention: 3 months after completion of RT (Week 24) |
| 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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
1. Confirmed prostatic carcinoma
2. Will undergo radiation therapy - radical radiation therapy or prostate-directed radiation therapy
3. 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
4. ECOG Performance status 0-1
5. Signed study-specific consent form
6. Patient willing and reliable for follow-up |
|
| ExclusionCriteria |
| Details |
Patients should have none of the following
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the Quality of Life as measured by FACIT-F |
At 24 weeks and at 36 weeks after the start of ADT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adherence to the prescribed exercise protocol measured at 24 weeks and at 36 weeks after the start of ADT |
At 24 weeks and at 36 weeks after the start of ADT |
| Changes in the Quality of Life as measured by FACT-G and EORTC - PR25 |
At 24 weeks and at 36 weeks after the start of ADT |
| Functional performance of the patients |
At 24 weeks and at 36 weeks after the start of ADT |
| Body Composition of the patients |
At 24 weeks and at 36 weeks after the start of ADT |
|
|
Target Sample Size
|
Total Sample Size="175"
Sample Size from India="175"
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="4"
Months="0"
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 - YES
- What data in particular will be shared?
Response (Others) - Not yet decided
- What additional supporting information will be shared?
Response (Others) - Not yet decided
- Who will be able to view these files?
Response (Others) - Not yet decided
- For what types of analyses will this data be available?
Response (Others) - Not yet decided
- By what mechanism will data be made available?
Response (Others) - Not yet decided
- For how long will this data be available start date provided 01-02-2028 and end date provided 31-01-2033?
Response (Others) - Not yet decided
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Rationale: Androgen deprivation therapy is an important component of prostate cancer treatment. This acts by reducing the testosterone levels in the body and thereby cutting off the primary factor which is driving prostate cancer growth. However, testosterone in addition to being the sexual hormone it is also needed for several other protective functions in the body. These include maintaining bone strength, muscle strength, cardiovascular safety, maintaining sugar and cholesterol levels etc. Hence, any reduction in testosterone levels leads to side effects related to these factors resulting in metabolic syndromes, bothersome fatigue, loss of muscle power etc. Exercises have been shown to help in reducing many of these side effects including fatigue and improving muscle strength. While supervised exercise sessions are recommended it is difficult for our patients to get access to such facilities and availability of expertise in the community is a concern. In view of this, in standard practice patients are referred to the rehabilitation services for advice on exercises and after that the patients continue these at home.
Novelty: The present study is looking to leverage the patient’s visit to the hospital for radiation therapy procedures to give them more frequent visits to the rehabilitation services for supervised sessions to improve adherence to the exercise protocol and thereby improve the quality of life of patients.
Aim: The aim of this study is to test the effectiveness of frequent visits to the rehabilitation services in improving adherence and quality of life of patients on androgen deprivation therapy.
Objectives: To assess whether more frequent visits to the rehabilitation services for monitoring of the exercises lead to better adherence to exercises and result in better quality of life of the patients. We will assess the difference in the functional status and body composition between the two groups.
Methods: This will be a two-arm prospective randomised controlled, open-label, parallel-group, superiority trial.
Expected outcome: Incorporation of frequent visits to rehabilitation services is likely to result in increased adherence in doing regular exercises and lead to better quality of life in terms of reduction in fatigue levels. There may also be improvements in functional status and body composition measures with the intervention. |