Breast cancer
Conditions
Interventions
Trade Name: Iscador® M 0.01mg
Product Name: Iscador® M 0.01mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Fermented, aqueous extract from Viscum album L (mistletoe) from apple tre
Sponsors
Research, Enterprise & Development (RED), University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female patients with a new diagnosis of early or locally advanced breast cancer, up to 8 weeks following definitive breast surgery whose treatment plan includes chemotherapy with or without radiotherapy. Patients will be recruited from 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. Inclusion criteria a) Female 18 years or over b) Histological verification of early breast cancer (T1 – 3, N0 – 3, M0) without clinical suspicion/evidence of distant metastases on routine staging investigations c) Planned adjuvant chemotherapy with or without radiotherapy regime d) Willing to self-administer or have a nominated person e.g. relative to administer subcutaneous injections e) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 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) No active, uncontrolled infection h) Randomisation within 8 weeks of surgery i) 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 j) 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 k) 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 l) No concomitant medical, psychiatric or geographic problems that might prevent completion of therapy 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 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Exclusion criteria a) Hospital inpatients. b) Additional immunomodulatory therapy c) Patients with known serious viral infection such as active Hepatitis B, Hepatitis C or HIV d) 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) e) Patients not able or willing to give informed consent f) Known allergy to mistletoe preparations g) Previous or current use of mistletoe h) Patients with brain and bone marrow tumours or brain metastases. i) Acute inflammatory or pyrexial conditions j) Chronic granulomatous diseases, active auto-immune diseases k) Hyperthyroidism with tachycardia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim: To test the feasibility of a placebo-controlled double-blind RCT of mistletoe therapy in patients with breast cancer undergoing chemotherapy with or without radiotherapy. There will be three arms (groups) in the trial ISCADOR M, ISCADOR P with physiological saline as the placebo. Objectives: We want to test the trials feasibility in terms of the: Recruitment of the patients into the trial Retention of participants through the full duration of the trial Completeness of follow up assessments Blinding of participants to study group allocation.;Secondary Objective: The secondary objectives are to understand the trial participants’ experience of the mistletoe/placebo therapy and of the nurses supervising treatment, with a view to improving the trial design. Also to explore therapy related symptoms and health related quality of life in the sample population. These objectives 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, via a nested qualitative study, to analyse their reasons and inform our recruitment strategy for the main trial.;Primary end point(s): To test the feasibility of a, placebo-controlled, double-blind RCT of mistletoe therapy in patients with breast cancer undergoing chemotherapy with or without radiotherapy. There will be three arms (groups) in the trial ISCADOR M, ISCADOR P with physiological saline as the placebo. Objectives To test the trials feasibility in terms of the: - recruitment of the patients into trial - retention of participants through the full duration of the trial - completeness of follow up assessments - blinding of participants to study group allocation ;Timepoint(s) of evaluation of this end point: These will be administered as one questionnaire at: Baseline: following randomisation and before start of chemo/radiotherapy regime Time point one: Ha | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objective is to understand the trial participants’ experience of the mistletoe/placebo therapy 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.;Timepoint(s) of evaluation of this end point: During and possibly immediately after the intervention/placebo administration period of the trial. | — |
Countries
United Kingdom
Outcome results
None listed