Structured teaching module for Hand foot syndrome Colorectal cancer

EFFECT OF STRUCTURED TEACHING MODULE ON INCIDENCE OF THE CAPECITABINE INDUCED HAND FOOT SYNDROME IN PATIENTS OF COLORECTAL CANCER AT TERTIARY CANCER CARE CENTRE A PROSPECTIVE RANDOMISED CONTROLLED STUDY

Status

Recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/08/007210

Enrollment

280

Registered

2016-08-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Colorectal cancer Health Condition 2: C189- Malignant neoplasm of colon, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: patients above age of 18 yrs Planned for Capecitabine based chemotherapy for colorectal cancer in adjuvant or metastatic setting Can either read or write English, or Hindi or Marathi. Creatinine clearance > 60 ml/min Receiving capectabine in dose of 2000mg/m2/day

Exclusion criteria

Exclusion criteria: Patients who are not willing to participate in the study patients with previous history of hand foot syndrome Previous exposure to 5-FU or Capecitabine Chemotherapy regimens which increase capecitabine induced toxicities e.g. irinotecan induced diarrhea requiring dose reduction of both Capecitabine and irinotecan. LFTs : AST/ALT > 3 ULN, bilirubin > 1.5 ULN, Albumin

Design outcomes

Secondary

Measure	Time frame
To evaluate in a multivariate analysis the effect of several pre-treatment factors on the occurrence of grade 3 or worse diarrhoea. The factors will be treatment arm, BMI, gender, Age, Albumin, and haemoglobinTimepoint: 2 year	—

Primary

Measure	Time frame
To study the effect of Structured Teaching module (STM) on incidence and severity of Hand Foot syndrome among patients receiving Capecitabine based chemotherapy for colorectal cancer at a Tertiary Cancer Care CentreTimepoint: 2 year	—

Countries

India

Contacts

Public ContactVikas Ostwal

Tata Memorial Hospital

tarachandg@gmail.com9819081403

Outcome results