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Clinical Trials/CTRI/2024/05/067186
CTRI/2024/05/067186
Not yet recruiting
Phase 2/3

Integrative approach for improving the Quality of Life of Cancer patients treated with Radiotherapy and Chemotherapy

Department of Shalya tantra Banaras Hindu University1 site in 1 country100 target enrollmentStarted: May 23, 2024Last updated:

Overview

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Department of Shalya tantra Banaras Hindu University
Enrollment
100
Locations
1
Primary Endpoint
Quality of Life

Overview

Brief Summary

This study is a randomized, open label, parallel group, single center trial, comparing the side effects and quality of life in Head and Neck cancer and Breast cancer patients who receive immune-modulator herbs and those who do not receive immune-modulator herbs following Radiotherapy and Chemotherapy for 6 months in 100 patients in Sir Sunderlal Hospital, Banaras Hindu University, India. The primary outcome is to assess the effects of immune-modulators on Quality of life in Head and neck and Breast cancer patients.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Histologically proven and newly diagnosed patients of Head & Neck and Breast cancer patients with no metastasis, ECOG performance scale 0-1, normal hematological, renal and hepatic parameters.

Exclusion Criteria

  • previously treated for any cancer and on any other alternative medicine.

Outcomes

Primary Outcomes

Quality of Life

Time Frame: Monthly till 6 months

Secondary Outcomes

  • Side effects(Monthly till 6 months)

Investigators

Sponsor
Department of Shalya tantra Banaras Hindu University
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Rashmi Gupta

IMS, BHU

Study Sites (1)

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