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Trial registered on ANZCTR


Registration number
ACTRN12609000163202
Ethics application status
Approved
Date submitted
3/03/2009
Date registered
3/04/2009
Date last updated
4/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised phase IIb, placebo controlled trial to assess the efficacy and safety of ReCharge (a medical food) in preventing chemotherapy induced diarrhoea (CID) when administered daily to patients undergoing chemotherapy.
Scientific title
A randomised phase IIb, placebo controlled trial to assess the efficacy and safety of ReCharge (a medical food) in preventing chemotherapy induced diarrhoea (CID) when administered daily to patients undergoing chemotherapy.
Secondary ID [1] 259986 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy induced diarrhoea 4412 0
Condition category
Condition code
Oral and Gastrointestinal 4672 4672 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each patient is expected to ingest a single 100g tub of the investigational product (ReCharge) per day for a total of 8 weeks, starting 2 weeks +/- 4 days before chemotherapy and continuing for the first 6 weeks of chemotherapy. ReCharge icecream is a medical food which contains two milk bioactive components, milk fat and lactoferrin.
Intervention code [1] 4150 0
Prevention
Comparator / control treatment
Each patient is expected to ingest a single 100g tub of placebo per day for a total of 8 weeks, starting 2 weeks +/- 4 days before chemotherapy and continuing for the first 6 weeks of chemotherapy. Placebo will contain energy-matched soy (16%) based ice cream.
Control group
Placebo

Outcomes
Primary outcome [1] 5537 0
The primary objective is to assess the efficacy of ReCharge ice cream formulation in reducing days with chemotherapy induced diarrhoea (CID) when administered once a day to patients undergoing chemotherapy. The primary outcome will be assessed by a daily patient diary.
Timepoint [1] 5537 0
8 weeks after commencing ingesting the study product.
Secondary outcome [1] 9325 0
To assess the incidence of CID as measured by completion of a daily patient diary for 8 weeks of treatment. Any patient who experiences at least one day of diarrhoea while on chemotherapy will be counted as having experienced CID.
Timepoint [1] 9325 0
8 weeks after commencing ingesting the study product.
Secondary outcome [2] 262006 0
To assess diarrhoea related quality of life as measured by the Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D) quality of life questionnaire.
Timepoint [2] 262006 0
Day 1 and 2, 4, 6, 8 and 12 weeks following the start of study product.
Secondary outcome [3] 262007 0
To assess the duration and severity of neutropenia by measuring full blood count during cycle 1 of chemotherapy.
Timepoint [3] 262007 0
Days 1, 3, 5, 8, 10, 12, ( and days 15, 18, 21 if on a 3 weekly regimen) of cycle 1
Secondary outcome [4] 262008 0
To assess overall health related quality of life as measured by the FACIT-D quality of life questionnaire.
Timepoint [4] 262008 0
Day 1 and 2, 4, 6, 8 and 12 weeks following the start of study product.
Secondary outcome [5] 262009 0
To assess safety of ReCharge by monitoring by health care professionals.
Timepoint [5] 262009 0
Day 1 and 2, 4, 6, 8 and 12 weeks following the start of study product.
Secondary outcome [6] 262010 0
To assess the effect of ReCharge on delivery of chemotherapy by calculating the proportion of patients who receive at least 75% of the planned dose over the 6 weeks of chemotherapy.
Timepoint [6] 262010 0
4, 6 and 8 weeks following the start of study product
Secondary outcome [7] 262011 0
To assess the effect of ReCharge on use of anti-diarrhoeal medication as measured by completion of a daily patient diary.
Timepoint [7] 262011 0
8 weeks after commencing ingesting the study product
Secondary outcome [8] 262012 0
To assess the severity of CID by monitoring by health care professionals.
Timepoint [8] 262012 0
Day 1 and 2, 4, 6, 8 and 12 weeks following the start of study product.

Eligibility
Key inclusion criteria
Patient with an early stage cancer suitable for adjuvant chemotherapy or an advanced cancer requiring chemotherapy
Patients due the first cycle of a chemotherapy regimen (1st, 2nd or 3rd line) with >4 weeks since last regimen *Patient is > 18 years of age *Patient’s therapeutic regimen includes capecitabine, docetaxel, paclitaxel, 5-Fluorouracil (5FU), irinotecan or a combination of agents including one of the above *Patient’s chemotherapy regimen has cycles of 2 or 3 weeks length *Written informed consent *Patient can tolerate ice cream *ECOG (Eastern Cooperative Oncology Group) performance status <3 *Adequate organ function as defined as: Haematological – Haemaglobin > 90g/L, absolute neutrophil count(ANC) >1.5 x 109/L, platelets >100 x109/L; Liver function- bilirubin = 2 x upper limit normal(ULN), aspartate transaminase(AST)/alaninine transaminase (ALT)/ Alkaline phosphatase (ALP) = 2.5 x ULN or = 5 x ULN in presence of liver metastases, albumin= 30 g/L;Renal function- Creatinine clearance > 50 mL/min
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with Type I or uncontrolled Type II diabetes. Patients with satisfactory controlled Type II diabetes as defined as a stable haemoglobin A1c (HbA1c) are eligible.
Patient’s chemo-radiation regimen includes radiation to the abdomen *Past history of intolerance or allergy to cow’s milk, soy or nuts *Patients with diabetes *Patients with a current stoma *Patients diagnosed with coeliac disease *Patients who are taking iron supplements within 7 days of starting study product *Patients with planned granulocyte colony stimulating factor (G-CSF) support
Patient has participated in another clinical study within the last 4 weeks before inclusion or currently participating in another clinical study involving any non-chemotherapy therapeutic substance which can influence bowel function or the blood count

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomly allocated to ReCharge or placebo. Patients, medical, nursing and research staff at the study centres will be blinded to treatment allocation. Lists of random allocation will be provided to the pharmacy at each study site, who will distribute the appropriate ice cream in identical tubs labelled according to regulatory requirements and marked with an identification number. The randomisation lists and patient identifiers will be confidential to the study statistician , pharmacy specific monitor and the pharmacies.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be stratified and blocked on study centre and length of chemotherapy cycle (two versus three weeks). Random block sizes will be used to provide maximum concealment of allocation.".
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 1606 0
New Zealand
State/province [1] 1606 0

Funding & Sponsors
Funding source category [1] 4597 0
Commercial sector/Industry
Name [1] 4597 0
LactoPharma
Country [1] 4597 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fonterra Co-operative Group Limited
Address
Fonterra Centre, Level 5, 9 Princes Street, Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 4146 0
None
Name [1] 4146 0
Address [1] 4146 0
Country [1] 4146 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6646 0
Multi Region Ethics Committee (MREC)
Ethics committee address [1] 6646 0
Ethics committee country [1] 6646 0
New Zealand
Date submitted for ethics approval [1] 6646 0
26/02/2009
Approval date [1] 6646 0
18/06/2009
Ethics approval number [1] 6646 0
MEC 09/03/031

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29343 0
Address 29343 0
Country 29343 0
Phone 29343 0
Fax 29343 0
Email 29343 0
Contact person for public queries
Name 12590 0
Dr David Perez
Address 12590 0
Consultant Oncologist
Dunedin Hospital
201 Great King Street
Dunedin 9016
Country 12590 0
New Zealand
Phone 12590 0
+64 3 474 0999
Fax 12590 0
Email 12590 0
David.Perez@southerndhb.govt.nz
Contact person for scientific queries
Name 3518 0
Arie Geursen
Address 3518 0
Fonterra Centre, Level 5, 9 Princes Street, Auckland 1010
Country 3518 0
New Zealand
Phone 3518 0
+64 9 374 9590
Fax 3518 0
Email 3518 0
Arie.Geursen@fonterra.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.