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A study to evaluate role of Zinc in decreasing radiation induced diarrhea in patients of carcinoma cervix undergoing pelvic radiotherapy.

A Prospective study to evaluate role of Zinc in decreasing morbidity from diarrhea resulting from pelvic radiation in patients of carcinoma cervix. - none

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/08/004819
Enrollment
200
Registered
2014-08-04
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- Biopsy proven squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma of cervix, FIGO stage IB- IV A undergoing chemoradiation.

Interventions

Intervention1: Zinc supplementation 40mg/day starting from one week prior to treatment until completion of treatment.: Patients will be supplemented with zinc 40mg/day starting from one week prior to

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Biopsy proven cancer cervix stage IB- IIIB • Karnofsky Performance Status minimum 70 • Patient fit for concurrent chemotherapy • Patient informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
To assess acute gastro-intestinal toxicity during and at treatment completion. Timepoint: Weekly during radiation treatment. At completion of treatment(41/2 to 5 weeks from onset of radiotherapy)

Secondary

MeasureTime frame
To assess the Quality of life at treatment completion.Timepoint: At treatment completion

Countries

India

Contacts

Public ContactDr Vijai Simha

Post Graduate Institute of Medical Education and Research, Chandigarh

bhavana1035@gmail.com91-9814635706

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026