| CTRI Number |
CTRI/2025/04/085017 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
13/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check the effectiveness of oral metronomic therapy in improving the quality of life in advanced head and neck cancer patients. |
|
Scientific Title of Study
|
Effectiveness of oral metronomic therapy vs supportive management in improving quality of life in metastatic and recurrent head and neck cancer: A randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishakha Pandey |
| Designation |
Junior Resident, Department of Onco-Anesthesia and Palliative Medicine |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Palliative Care Unit, first floor, room 154, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS- New Delhi campus
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
6307724800 |
| Fax |
|
| Email |
vishakhap009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Mishra |
| Designation |
Professor- Department of Onco-Anesthesia and Palliative Medicine |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Palliative Care Unit, first floor, room 154, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS- New Delhi campus
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9899061105 |
| Fax |
|
| Email |
seemamishra2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Mishra |
| Designation |
Professor- Department of Onco-Anesthesia and Palliative Medicine |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Palliative Care Unit, first floor, room 154, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS- New Delhi campus
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9899061105 |
| Fax |
|
| Email |
seemamishra2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Onco-Anesthesia and Palliative Medicine, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, New Delhi pin- 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
Ansari Nagar, New Delhi pin- 110029 India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishakha Pandey |
DR B.R. Ambedkar Institute Rotary Cancer Hospital |
Palliative Medicine OPD- Room number 60, Department of Onco Anesthesia and Palliative Medicine, ground floor, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
DELHI
110029
India
South
DELHI |
6307724800
vishakhap009@gmail.com |
| Dr Vishakha Pandey |
National Cancer Institute |
Palliative Medicine OPD, Department of Onco Anesthesia and Palliative Medicine, first floor, OPD Building, National Cancer Institute, Badsa, Jhajjar, Haryana pin-124105, Jhajjar, Haryana, India
Jhajjar
HARYANA |
6307724800
vishakhap009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee- All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Metronomic Therapy drugs |
Oral Metronomic Therapy drugs- methotrexate (10 mg/m² weekly), celecoxib(200mg twice daily) and geftinib(250mg once daily) to be given and evaluated at baseline, 2 months, 4 months and 6 months. |
| Comparator Agent |
Supportive Management |
Supportive management including analgesics, nutritional support and other symptomatic management to be given and evaluated at regular intervals(baseline, 2 months, 4 months and 6 months) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients(more than or equal to eighteen years) diagnosed with metastatic or recurrent head and neck cancers.
2. Patients with Eastern Cooperative Oncology Group performance scale of more than or equal to two.
3. Patients who can understand either English or Hindi. |
|
| ExclusionCriteria |
| Details |
1. Patients below eighteen years of age.
2. Patients with significant co-morbid conditions that preclude safe participation in the study.
3. Pregnant or breastfeeding women, due to potential drug teratogenicity.
4. Patients with a known contraindication to the drugs used in OMT(e.g., allergy to methotrexate or celecoxib).
5. Patients with ECOG PS more than or equal to two.
6. Patients who do not understand either Hindi or English.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of this study is to evaluate the effectiveness of oral metronomic therapy (OMT) in improving the quality of life (QoL) using the EORTC QLQ-C30 and QLQ-HN35 questionnaire in patients with metastatic and recurrent head and neck cancer. |
At baseline, 2 months, 4 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Overall Survival (OS): To evaluate overall survival as a secondary outcome,
determining if OMT extends survival times in comparison to supportive care. |
It will be evaluated at 6 months. |
| Progression-Free Survival (PFS): To compare the progression-free survival rates between patients receiving OMT and those receiving supportive management. |
This will be evaluated using radiological imaging and reporting at 3 months and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
27/04/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Head and neck cancer possess a very high symptom burden in patients especially in advanced stages. However, the treatment options in such patients ware very limited. Various studies have been conducted showing the uses of OMT in patients of palliative intent or in patient with resectable tumors. The outcomes have been measured in terms of disease progression, survival, and QoL. Not many studies have been conducted showing effectiveness of oral metronomic therapy especially in head and neck cancer patients with poor performance. This protocol aims to further evaluate the efficacy of OMT compared to supportive management in improving the QoL of patients with advanced stages of head and neck cancer. This study plans to enrol a total of 200 patients with ECOGPS more than or equal to 2 with 100 patients in each study arm. Study conducted by Patil V (Patil et al 2020) reported a mean difference of -10 in the global health status (an effect size of 0.55) among those on OMCT at 6 months. However, the above study included only patients with ECOGPS less than or equal to 2. As the current study focusses on patients with ECOGPS more than or equal to 2, we assume a lower effect size of Global Health status at 6 months compared to that reported by Patil V. Assuming an effect size of 0.40 in this current study, a minimum of 78 patients are required in each arm at an alpha of 0.05 and 80% power. Given a dropout rate of approximately 20%, 94 patients in each arm will be required. |