A clinical trial to evaluate the quality of life with AYUSH QOL 2C in patients of Non metastatic breast cancer as an adjuvant to chemotherapy
- Conditions
- Health Condition 1: null- Female Non Metastatic Breast Cancer patients receiving Chemotherapy
- Registration Number
- CTRI/2010/091/001247
- Lead Sponsor
- CCRAS AYUSH New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 80
Patients of breast cancer.
Age eligibility for study : 18 years and older
Gender eligible for study : Female
Disease characteristics : Histologically confirmed Cancer breast
Patient characteristics : Over 18 years, of age
Performance status : ECOG grade up to 2
Life expectancy : At least 3 months
Haematopoietic : WBC greater than 4000/mm3
Platelet count > 100,000 mm3
Hepatic : Bilirubin less than 1.5 mg/ dl
SGOT & SGPT more than 2 times normal
Renal : Creatinine less than 1.5 mg/ dl
Other : No concurrent active infection.
No prior malignancy.
Not pregnant or nursing
Effective contraception for all Prior : Biologic therapy: not specified
Chemotherapy : no prior chemotherapy
Known secondary neoplasia or central nervous system metastases. Acute or chronic leukemias. Lymphoma or multiple myeloma.
Body weight below 40 kg
Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective birth control measures Concurrent severe or uncontrolled medical disease.
Acute or chronic liver disease.
Confirmed diagnosis of HIV.
Uncontrolled diabetes.
Surgery less than 2 weeks prior to entry ( or not recovered from effects of surgery)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TO EVLUATE THE EFFICACY OF AYUSH QOL 2C in improving Quality of Life [QOL]in non metastatic breast cancer female patients receiving chemotherapyTimepoint: Every 21 days till patient receives 4 or 8 chemotherapy cycles & at 6th month, 9th month, & final follow up at one year.
- Secondary Outcome Measures
Name Time Method TO MONITOR THE SAFETY OF AYUSH QOL 2C in FEMALE PATIENTS WITH non-metastatic BREAST CANCER AS AN ADJUVANT to CHEMOTHERAPYâ?? <br/ ><br> <br/ ><br>â??TO ASSESS THE IMPROVEMENT IN QUALITY OF LIFE OF BREAST CANCER PATIENTS SUFFERING FROM GRADE I ,II & III receiving CHEMOTHERAPY FOLLOWING ADMINISTRATION of AYUSH QOL 2C as supplement to chemotherapy at each chemotherapy cycle and at 6 months and one year AFTER THE TREATMENTâ?? <br/ ><br>Timepoint: Every 21 days till patient receives 4 or 8 chemotherapy cycles & at 6th month, 9th month, & final follow up at one year.