Health Condition 1: null- patients must have histologically confirmed squamous cell cancers of the Head and neck region warranting palliative chemotherapy
Conditions
Interventions
Intervention1: NA: NA
Control Intervention1: NA: NA
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants must have histologically confirmed squamous cell cancers of the Head and neck region warranting palliative chemotherapy 2. Age : Any age above 18 years. No maximum age. 3. ECOG performance status 4. Life expectancy of less than 12 months with standard palliative treatments. 5. Participants must have normal organ and marrow function as defined below: a. Leukocytes >=3,000/mcL b. Platelets >=100,000/mcL c. Total bilirubin d. AST(SGOT)/ALT(SGPT) e. Calculated Creatinine clearance > 30 ml/min 6. Both men and women of all races and ethnic groups are eligible for this trial 7. Ability to understand Hindi, Marathi or English language 8. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled intercurrent illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis) or psychiatric illness/social situations that would limit compliance with study requirements. Patients should be considered physiologically fit to withstand major cancer surgery. 2. Pregnant women and breastfeeding women are excluded from this study 3. HIV-positive, Hepatitis B and C seropositive patients are excluded from this study. 4. Patients with previous history of other cancers. 5. Patients who have been started on palliative chemotherapy regimen. ( Patients who have received previous palliative chemotherapy and awaiting start of second line chemotherapy are not excluded) ECOG PS 0-2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients opting for increase in survival as the primary expectation from chemotherapyTimepoint: Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The preferences for chemotherapy 2. Identify patients having high distress scores ( score 4 or more) and factors associated with it 1. Factors studied would be age (above or below 70 years), sex( Male/Female), socioeconomic status ( Above poverty line/ Below poverty line) and residential address ( Mumbai / Rest of Maharashtra / Rest of India). 3. To asses proportion of patients having improvement in QOL at 2 months with palliative chemotherapy Timepoint: 1.Day 1 2.Time point : Day 1 3.2 month | — |
Countries
India
Contacts
Public ContactDr Vijay Patil
Tata Memorial Hospital
Outcome results
None listed