Breast cancer MedDRA version: 14.0 Level: LLT Classification code 10006188 Term: Breast cancer female NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: HELIXOR® M 1mg
Product Name: HELIXOR® M 1 mg
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for in
Sponsors
Research, Enterprise & Development (UOB)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female patients with a new diagnosis of early or locally advanced breast cancer, 2-4 weeks following definitive breast surgery whose treatment plan includes chemotherapy with or without radiotherapy. Patients will be recruited from North Bristol NHS Trust and University Hospitals Bristol NHS Foundation Trust. Patients who are to receive only radiotherapy will be excluded as this treatment is generally well-tolerated and of short duration. Where appropriate patients who are recommended to receive Trastuzumab and/or endocrine therapy, as well as chemotherapy, are eligible. a) Over 18 years (no upper age limit) b) Histological verification of breast cancer c) Chemotherapy regime with or without radiotherapy d) Eastern Cooperative Oncology Group(ECOG)performance status 0 or 1 e) Survival expectancy >3 mths f) Completely resected disease with negative surgical margins(apart from deep margin if full thickness resection or involved radial margins following wide local excision if further surgery to the breast is planned on completion of chemotherapy) g) Early stage disease(T0-3 N0-2 M0) without clinical suspicion/evidence of distant metastases on routine staging. h) Definite indication for adjuvant therapy i) Fit to receive any of the treatments, with adequate bone marrow, hepatic and renal function i.e. Hb > 9g/dL; WBC > 3 x 109/L; platelets > 100 x 109/L Bilirubin within normal range (unless known Gilbert’s disease) AST/ALT = 1.5 x Upper limit of normal (ULN) Creatinine =1.5 x ULN and calculated creatinine clearance using Cockroft-Gault formula >50ml/min j) No active, uncontrolled infection k) Randomisation within 2-4 weeks of surgery l) No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except: Previous radiotherapy for basal cell carcinoma Previous pre-operative endocrine therapy provided that there was no evidence of progression during this therapy, that it was for less than 6 weeks in duration, and was stopped at least one month prior to trial entry m) No previous malignancy except in the case of DCIS, or basal cell carcinoma or cervical carcinoma in situ, or where the patient has been disease-free for 10 years, and where treatment consisted solely of resection n) Non-pregnant and non-lactating, with no intention of pregnancy during chemotherapy, and prepared to adopt adequate contraceptive measures if pre-menopausal and sexually active o) No concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: a) Hospital inpatients. b) Additional immunomodulatory therapy. c) Other serious disease, acute or chronic. d) Patients with known serious viral infection such as active Hepatitis B, Hepatitis C or HIV. e) Pregnancy or lactation. f) Only cytological proof of malignancy. g) Previous invasive breast cancer or bilateral breast cancer (DCIS or LCIS that has been surgically treated or is planned for surgical treatment post-chemotherapy is allowed provided there is no evidence of further disease in the contralateral breast). h) Patients not able or willing to give informed consent. i) Patients known not to be available for a minimum of 1.5 years’ follow-up. j) Known allergy to mistletoe preparations. k) Current or previous use of mistletoe l) Women who are non English speakers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Principal objective: to determine the feasibility of a clinical trial of mistletoe treatment for breast cancer in which the potential participants will either be allocated the (active) mistletoe treatment or an inactive (placebo) treatment during and immediately after a treatment plan including chemotherapy with or without radiotherapy. Our questions: *Will participants with newly diagnosed breast cancer want to participate in the trial? *Will participants cope with this additional treatment and stay in the trial until the end? *Will participants complete the follow-up assessment forms? *Will the participants and nurses providing treatment know whether they have received the active or placebo treatment? ;Secondary Objective: The secondary objective is to understand the experience of participants participating in the trial and of the nurses supervising treatment, with a view to improving the trial design. This objective will be achieved by interviews with participants and nurses and analysis of symptom diaries by participants. We will also seek to interview potential participants who have declined participation in the pilot, to analyse their reasons and inform our recruitment strategy for the main trial.; Primary end point(s): To test the feasibility of a parallel group, placebo-controlled RCT of mistletoe treatment in patients with breast cancer undergoing chemotherapy with or without radiotherapy and with or without herceptin. Specifically to test the trials feasibility in terms of the: • recruitment of patients into trial • retention of participants through the full duration of the trial • completeness of follow up assessments • blinding of participants and clinicians to treatment allocation ; Timepoint(s) of evaluation of this end p | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: During and possibly immediately after the intervention/placebo adminstration period of the trial. ;Secondary end point(s): To articulate the trial participants’ experiences of the mistletoe/placebo treatment, and of the trial procedures as a whole via interviews with participants and research nurses. | — |
Countries
United Kingdom
Outcome results
None listed