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
Rashmi Gupta
IMS, BHU
Study Sites (1)
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