Oral Chemotherapy for advanced head and neck cancer.

Phase 3

Not yet recruiting

• Conditions: Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,

• Registration Number: CTRI/2021/09/036296
• Lead Sponsor: NO

Brief Summary

Disease burden related to tobacco consumption and oral cancer is high in eastern region of Uttar Pradesh. Due to this, our study is planned to assess the effectiveness of different tobacco intervention methods for tobacco cessation as well as to find out potential pre malignant and malignant lesion and to provide appropriate health intervention at an earliest stage.

Screening camp will be organized in coordination of Municipal office Varanasi city. Total 1200 municipal employees will be enrolled in the study. In each camp around 100-150 employees will be invited to attend the cancer awareness session and free oral cancer screening. After the cancer awareness session, Informed consent will be obtained to participate in this study. Those who are not willing to participate in the study, oral cancer screening will be offered*.* Participants with suspected oral lesion will be referred to HBCH/MPMMCC as per the MOU signed between HBCH/MPMMCC and Municipal Office Varanasi.

Participants with current tobacco history will be randomly divided into groups for application of one of the behavioural intervention for tobacco cessation.  Participant will be followed up at 1 month, 3 months, 6 months and 1 year to assess the tobacco cessation. If they have found using tobacco during follow up, the same intervention will be repeated, which was applied during recruitment of the participant in the study, except for those who had received group counselling initially. These participants will be provided individual counselling during follow up. Analysis of tobacco cessation rate will be done by assessing level of dependence using Fagerstrom scale.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-04-09
• Study Start: 2021-09-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• 1.Head and neck cancers planned for palliative chemotherapy, post first line palliative chemotherapy failure a.Patients who have failed within 6 months of curative treatment, where chemotherapy was a part will be considered.
• 2.Age : Any age ≥18 years 3.ECOG performance status ≤2 4.Histopathologically or FNAC (Fine needle aspiration cytology) proof of cancer.
• 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 × institutional upper limit of normal d.AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal e.Calculated Creatinine clearance > 30 ml/min 6.The effects of chemotherapy on the developing human fetus are teratogenic.
• Hence women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of protocol.
• 7.Both men and women of all races and ethnic groups are eligible for this trial.
• 8.Willing and able to comply with all study requirements.
• 9.Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• 1.Participants who are currently receiving any other investigational agents.
• 2.Patients with QTc prolongation defined as QTc interval greater than 480 ms in view of risk of sudden cardiac death associated with use of ondansetron.
• Patients in whom an initial evaluation QTc is prolonged but with medical interventions it is restored to normal are eligible for the study.
• 3.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
• 4.Uncontrolled intercurrent illness including, but not limited to, active tuberculosis, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents within last 1 year, inflammatory bowel disease, known hyperkalemia ( CTCAE version 5 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients who have uncontrolled hypertension or diabetes or other chronic medical condition at initial evaluation but in whom these conditions are controlled with medical intervention can be assessed for eligibility.
• 5.Pregnant women and breastfeeding women are excluded from this study because Chemotherapy agents have the potential for teratogenicity or abortifacient effects.
• 6.Patients who are able to receive immunotherapy (both financially and medically fit for the same), will be excluded from this study All inclusion and exclusion criteria have to be satisfied for inclusion in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	6 Months

Secondary Outcome Measures

Name	Time	Method
1.QOL	2.Adverse event

Trial Locations

Locations (2)

Homi Bhabha Cancer Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

Mahamana Pandit Madan Mohan Malaviya Cancer Centre; 🇮🇳 Varanasi, UTTAR PRADESH, India

Homi Bhabha Cancer Hospital

🇮🇳Varanasi, UTTAR PRADESH, India

Dr BK Mishra

Principal investigator

9415214254

bkmishra@mpmmcc.tmc.gov.in