| CTRI Number |
CTRI/2022/02/040212 [Registered on: 11/02/2022] Trial Registered Prospectively |
| Last Modified On: |
10/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exercise, nutrition and mental well being support in reducing complications after surgery for cancer of ovary. |
|
Scientific Title of Study
|
Pre-habilitation in ovarian cancer cytoreductive surgery and its effect on postoperative morbidity (PROSPERITY): A randomized controlled trial |
| Trial Acronym |
PROSPERITY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasanna Vani Vanamail |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (W.I.A.) |
| Address |
10, surgical oncology block, Cancer Institute (W.I.A.), 38, Sardar Patel Road, Adyar, Chennai.
Chennai
TAMIL NADU
600036
India |
| Phone |
8946042271 |
| Fax |
|
| Email |
prasna.vani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna Vani Vanamail |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (W.I.A.) |
| Address |
10, surgical oncology block, Cancer Institute (W.I.A.), 38, Sardar Patel Road, Adyar, Chennai.
Chennai
TAMIL NADU
600036
India |
| Phone |
8946042271 |
| Fax |
|
| Email |
prasna.vani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanna Vani Vanamail |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (W.I.A.) |
| Address |
10, surgical oncology block, Cancer Institute (W.I.A.), 38, Sardar Patel Road, Adyar, Chennai.
Chennai
TAMIL NADU
600036
India |
| Phone |
8946042271 |
| Fax |
|
| Email |
prasna.vani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cancer Institute (W.I.A.) |
|
|
Primary Sponsor
|
| Name |
Cancer Institute |
| Address |
38, Sardar Patel Road,Adyar, Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prasanna Vani Vanamail |
Cancer Institute (WIA) |
38, Sardar Patel Road, Adyar, Chennai
Chennai
TAMIL NADU |
8946042271
prasna.vani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Cancer Institute (WIA) Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Prehabilitation group |
Exercise therapy
Strengthening activity will be prescribed 3 days per week, which includes exercises for 8 muscle groups for 30 minutes (including 5-minute warm up and 5-minute cool down ) 2 sets of 10 repetitions each. The exercises include: seated rows, chest fly, deltoid lift, bicep curls, triceps extensions, chair squats, hamstring curls, standing calf raises. In the interim three days of the week, participants will be asked to do brisk walking for twenty minutes on a levelled surface at moderate intensity.
Nutrition
Patients at severe nutrition risk will receive targeted nutrition treatment with oral nutrition supplements targeting 25 Kcal/day and protein 1.5g/kg/day.
Patients at risk based on NRS 2002 score3 and ≤5 will receive a formal nutrition assessment with 24 hours dietary recall will be done. Patients will be advised dietary modification to achieve intended calorie of 25 Kcal/day and protein 1.5g/kg/day. Multivitamins will be supplemented at 50% RDA.
Anemia correction
If patient has a haemoglobin (Hb) 11 g/dl, they will be investigated for causes of anemia. For patients with iron defeciecy anaemia intravenous iron will be given.
Patients with Hb 12G/dl will be given two capsules of Cap.2B12 once daily for 4 weeks. All patients with receive multivitamin and calcium with vitamin D supplements.
Psychological counselling
The intervention module involves a combination of psychoeducation, relaxation strategies, problem-solving and coping skills. The therapy session will be cognitive-behavioural in orientation.
|
| Comparator Agent |
Standard care group |
Patients in this group will receive routine standard of care including preoperative nutritional advice of high protein diet and incentive spirometry
If patient has Hb 12 g/dl, oral iron supplements with elemental iron content 60 mg / day will be given. All patients will be given multivitamin and calcium with vitamin D supplements. Compliance to oral medication will be assessed at weekly follow up and recorded.
If patient has NRS 2002 score 3 , high protein diet will be advised based on the dietary guidelines. (https://www.nin.res.in/downloads/DietaryGuidelinesforNINwebsite.pdf) All patients will be started on incentive spirometry exercises. A booklet adapted from WHO global recommendation on physical activity for health will be provided to the participants (https://www.who.int/publications/i/item/9789240015128). Postoperative chest physiotherapy will be given and incentive spirometry will be encouraged until four weeks postoperatively. Patients will be asked to continue high protein diet in the postoperative period for upto 4 weeks.
All patients who have postop hemoglobin11g/dL will be given oral iron supplements with elemental iron 60 mg per day for four weeks. Multivitamin and calcium with vitamin D supplementation will be continued for four weeks post surgery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Age > 18 years
2. Patients awaiting elective cytoreductive surgeries for ovarian cancer after completion of the due course of chemotherapy.
3. Time to surgery 2 to 6 weeks.
|
|
| ExclusionCriteria |
| Details |
1. Laparoscopic surgery
2. Heart disease with positive stress test
3. Chronic pulmonary disease with dyspnoea at exertion.
4. Limb immobility
5. Hemoglobin <7 g/dl
6. Acute infection
7. Known hypersensitivity to any drugs or to parenteral iron
8. Bronchial asthma
9. Chronic liver disease with SGOT, SGPT >3 times the upper limit of normal
10. Renal disease requiring dialysis
11. Inability to comprehend and perform the exercise interventions
12. Active bleeding from tumour
13. Massive ascites /pleural effusion refractory after the last cycle of chemotherapy
14. Patients for primary surgery will be excluded.(Surgery before chemotherapy)
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcomes are 30 day comprehensive complication index in the two groups. It will be assessed based on a online tool. (https://www.assessurgery.com/about_cci-calculator/ ) |
The primary outcomes are 30 day comprehensive complication index in the two groups. It will be assessed based on a online tool. (https://www.assessurgery.com/about_cci-calculator/ ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare, in patients undergoing ovarian cytoreductive surgeries, prehabilitation and conventional care with respect to
1. Six minute walk test- assessed on day before surgery and four weeks after surgery.
2. QOL- assessed on day before surgery, at discharge from hospital and four weeks after surgery.
3. Length of ICU stay
4. Perioperative blood transfusion- packed red cell transfusion within 2 weeks of surgery.
|
day before surgery, at discharge and 4 weeks after surgery |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/03/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prasna.vani@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Cancer of the ovaries is the third most common cancer in women. It also has the worst outcomes and high risk of death. This is due to lack of screening method, delayed symptom onset and insidious growth of the disease earning it the moniker of ‘the silent killer’. Cancer ovary is the leading cause of death from cancer in Indian women. Most of the patients are diagnosed in the advanced stages, stages 3 and 4, when only 28% of them have the chance of survival at 5 years. Treatment of most of the ovarian cancers includes chemotherapy followed by surgery and subsequent cycles of chemotherapy. Chemotherapy though beneficial in reducing the cancer extent, has concomitant side effects which predispose these patients to poor nutrition, anemia, decreased immunity, general debility and muscle wasting. These negatively impact their physical functioning in daily activities and predispose these patients to prolonged hospitalization, need for blood transfusions, post-surgical infections and also increase the health care costs. Post- surgical complications impair their quality of life and also reduce their chance of completion of subsequent cycles of chemotherapy. Consequently, they enter a state of life long dependency and the overall survival of these patients is also adversely affected. The patient factors adversely affecting their surgical outcome can be mitigated by prehabilitation. Prehabilitation is the process of improving the functional ability of the individual to enable them to ‘weather the storm’ of surgery. Prehabilitation incorporates components of exercise training, nutrition support and mental health counseling in the 2 to 4 weeks period before surgery. Prehabilitated patients are better placed to cope with surgery and avoid or overcome complications. Even if the prehabilitated patients develop a complication, they have the reserve to recover and maintain a life of independence. The aim of the proposed project is to investigate the feasibility of prehabilitation in patients undergoing surgery for cancer ovary after chemotherapy and to determine its effects on reducing the complications post-surgery as compared to the current standard care. |