A study to evaluate role of Zinc in decreasing radiation induced diarrhea in patients of carcinoma cervix undergoing pelvic radiotherapy.
Phase 2
Recruiting
- Conditions
- Health Condition 1: null- Biopsy proven squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma of cervix, FIGO stage IB- IV A undergoing chemoradiation.
- Registration Number
- CTRI/2014/08/004819
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
•Biopsy proven cancer cervix stage IB- IIIB
•Karnofsky Performance Status minimum 70
•Patient fit for concurrent chemotherapy
•Patient informed consent
Exclusion Criteria
•KPS less than 60
•Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
•Metastatic disease beyond para-aortic region (L1-L2)
•Previous pelvic or abdominal radiotherapy
•Previous total or partial hysterectomy
•Combination of preoperative radiotherapy with surgery
•Patients receiving BT only
•Patients receiving EBRT only
•Patients receiving neoadjuvant chemotherapy
•Active infection or severe medical condition endangering treatment delivery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess acute gastro-intestinal toxicity during and at treatment completion. <br/ ><br>Timepoint: Weekly during radiation treatment. <br/ ><br>At completion of treatment(41/2 to 5 weeks from onset of radiotherapy) <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess the Quality of life at treatment completion.Timepoint: At treatment completion