Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C039- Malignant neoplasm of gum, unspecified Health Condition 3: C138- Malignant neoplasm of overlappingsites of hypopharynx Health Condition 4: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Health Condition 5: C118- Malignant neoplasm of overlappingsites of nasopharynx Health Condition 6: C068- Malignant neoplasm of overlappingsites of other and unspecified parts of mouth
Conditions
Interventions
Intervention1: Pantoprazole, Ranitidine, Aprepitant, Capecitabine, Methotrexate. Erlotinib, Celecoxib, Tramadol, Alprazolam, Fluconazole: The drugs will be administered as a part of routine management
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients, who are on study drugs and are able to swallow tablets as whole and also those who are unable to swallow the formulation as whole (those who are on Naso Gastric tube or PEG tube as well as those who are on liquid diet). 2. ECOG PS <= 2
Exclusion criteria
Exclusion criteria: 1. History of allergy to the study drug they are prescribed. 2. Patients with esophageal or gastric surgery. 3. Patients with known gastrointestinal diseases like malabsorption syndromes, iliac sprue, Crohnâ??s disease, irritable bowel syndrome. 4. Patients being prescribed on any of the study drug in the last 2 weeks. 5. Patients with severe nausea or vomiting or diarrhea of grade >=2 in the last 24hrs. 6. Patients on drugs (as enlisted in Table 2) which can alter the GI motility 7. Patients with major organ dysfunction, Active bleeding, hemodynamic instability 8. Any other medical condition or any abnormal lab findings which may adversely affect the patient, based on physician discretion. 9. Patients on any drug which is an enzyme inducer or inhibitor as enlisted in (Table 3). 10. Smoking / consumption of alcohol within one week of entering into the study 11. Consumed grapefruit juice within one week of entering into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of Pharmacokinetic parameters ( Cmax, AUC, Vd,tmax, t1/2,Clearance) of the administered drugs in cancer patients taking crushed vs whole formulations of drugsTimepoint: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of NG tube/PEG tube on pharmacokinetics of administered drugsTimepoint: 5 years | — |
Countries
India
Contacts
Public ContactDr Manjunath Nookala
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), TMC
Outcome results
None listed