A study to find out the effect of crushing and administering the tablets/capsules on the drug levels in the blood

Not Applicable

Conditions: Health Condition 1: C01- Malignant neoplasm of base of tongueHealth Condition 2: C039- Malignant neoplasm of gum, unspecifiedHealth Condition 3: C138- Malignant neoplasm of overlappingsites of hypopharynxHealth Condition 4: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynxHealth Condition 5: C118- Malignant neoplasm of overlappingsites of nasopharynxHealth Condition 6: C068- Malignant neoplasm of overlappingsites of other and unspecified parts of mouth

Registration Number: CTRI/2018/01/011458

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures