Adjuvant Homoeopathic Management for side effects from chemotherapy in breast cancer patients

Phase 1

• Conditions: Health Condition 1: null- Side effects of chemotherapy in breast cancer patients

• Registration Number: CTRI/2011/12/002271
• Lead Sponsor: Central Council for Research in Homoeopathy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

?Females, 18 years or over, with any stage of any type of breast cancer undergoing chemotherapy

?Patient having any two of the following side effects of chemotherapy viz. nausea, vomiting, abdominal pain, diarrhea, constipation, decreased appetite, hair loss, fatigue reporting within 2 weeks of chemotherapy.

?Patient should not be under Homoeopathic treatment for the side effects of chemotherapy

?Patients able to take self care

?Patients willing to sign written informed consent

?Hb% more than 6.5 gm%

Exclusion Criteria

?Inability to comply with the study protocol, including psychiatric disease

?Features of renal failure (urea more than 50 mg%, creatinine more than 2 mg %)

?Features of gastro intestinal obstruction

?Patients deemed ineligible by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Edmonton Symptom Assessment Scale: Revised Version (ESAS-r)Timepoint: patients will be assessed as per Edmonton Symptom Assessment Scale: Revised Version (ESAS-r)on 3rd and 7th day of homoeopathic treatment after each chemotherapy session. If the patient is not receiving subsequent chemotherapy course, ESES-r is to be filled up every month till 4 months.

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ-C30 and QLQ-BR23Timepoint: To assess the Health Related Quality of Life: EORTC QLQ-C30 and QLQ-BR23 at 1st and 7th day of homoeopathic treatment after each chemotherapy session. If the patient is not receiving subsequent chemotherapy course, EORTC QLQ-C30 and QLQ-BR23 is to be filled up every month till 4 months.