Study to find the distress, expectations, preferences and QOL in patients treated with palliative chemotherapy in Head and neck cancers

Not Applicable

• Conditions: Health Condition 1: null- patients must have histologically confirmed squamous cell cancers of the Head and neck region warranting palliative chemotherapy

• Registration Number: CTRI/2015/11/006392
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 200

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 <=2

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 < 1.5 times normal

d.AST(SGOT)/ALT(SGPT)<=2.5 Ã? institutional upper limit of normal

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified