To Compare And Evaluate Side Effect Profile Of Cancer Patients Undergoing Current Treatment along with Food Supplements

Not Applicable

Conditions: Health Condition 1: C50- Malignant neoplasm of breastHealth Condition 2: O- Medical and Surgical

Registration Number: CTRI/2021/04/032808

Lead Sponsor: ichiIn Biosciences Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Aged 18 to 65.

2. Patients who diagnosed with breast cancer.

3. Patients who are on 1st and 2nd cycles of chemotherapy.

4. Diagnostic histopathology of Breast Cancer stage II and above.

5. Subjects with any co-morbid conditions can be added.

6. Patient who are willing into participate in the study with a written Informed Consent. Form.

Exclusion Criteria

1. Have previously received any cancer therapy including but not limited to radiotherapy, chemotherapy and surgery.

2. Use of GCSF-Granulokine Â® (growth-stimulating factor granulocyte).

3. Use of immunosuppressive drugs, diuretics and supplements of zinc or copper.

4. Use of other supplements during the study duration.

5. Significant cardiac, pulmonary, renal, hepatic, gastrointestinal, CNS, psychiatric disease or illicit substance use/abuse that in the opinion of the investigator would make the participant a poor candidate for study participation.

6. Patients with a history of autoimmune or inflammatory disease, active infectious disease, liver disease or renal failure.

7. Pregnancy (for women of childbearing potential)/lactation.

8. Systemic use of progestinâ??s, androgens or other steroids -dexamethasone is allowed if used as antiemetic therapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Assessment of side effects in different study group. <br/ ><br>2. Quality of Life (EORTC QLQ-C30 Questionnaire) (18): Better scores in the questionnaire after intervention <br/ ><br>Timepoint: Assessment will be done on 15th day of each arm

Secondary Outcome Measures

Name	Time	Method
1. Immunology and Blood parameters Panel (Complete Blood Count, Neutrophils to Lymphocyte ratio, IL6, Tumor Necrosis Factor Î±, C-Reactive Protein Levels, ESR, FACS for CD56, CD16, CD3, CD4 and CD8 from peripheral blood) Improvement Metrics.Timepoint: Adverse events monitoring every visit