Request Number:
083664
ACTR Number:
ACTRN12609000163202
Trial Status:
Registered
Date Submitted:
3/03/2009
Date Registered:
3/04/2009
Page 1
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.
ANZCTR registration
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:
UTN:
Trial acronym:
Page 2
Health condition(s) or problem(s) studied:
Chemotherapy induced diarrhoea
Condition category:
Condition code:
Oral and Gastrointestinal
Other diseases of the mouth, teeth,
oesophagus, digestive system including
liver and colon
Page 3
Description of
intervention(s) /
exposure:
Intervention code:
Comparator / control
treatment:
Control group:
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 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.
Prevention
Each patient is expected to ingest a single 100g
tub of placebo per day for a total of 8 weeks,
starting 2 weeks before chemotherapy and
continuing for the first 6 weeks of chemotherapy.
Placebo will contain energy-matched soy (16%)
based ice cream.
Placebo
Page 4
Primary outcome:
Timepoint:
Secondary outcome
1:
Timepoint:
Secondary outcome 2:
Timepoint:
Secondary outcome 3:
Timepoint:
Secondary outcome 4:
Timepoint:
Secondary outcome 5:
Timepoint:
Secondary outcome 6:
Timepoint:
Secondary outcome 7:
Timepoint:
Secondary outcome 8:
Timepoint:
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.
8 weeks after commencing ingesting the study
product.
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.
8 weeks after commencing ingesting the study
product.
To assess diarrhoea related quality of life as
measured by the Functional Assessment of
Chronic Illness Therapy-Diarrhea (FACIT-D)
quality of life questionnaire.
Day 1 and 2, 4, 6, 8 and 12 weeks following the
start of study product.
To assess the duration and severity of
neutropenia by measuring full blood count during
cycle 1 of chemotherapy.
Days 1, 3, 5, 8, 10, 12, ( and days 15, 18, 21 if
on a 3 weekly regimen) of cycle 1
To assess overall health related quality of life as
measured by the FACIT-D quality of life
questionnaire.
Day 1 and 2, 4, 6, 8 and 12 weeks following the
start of study product.
To assess safety of ReCharge by monitoring by
health care professionals.
Day 1 and 2, 4, 6, 8 and 12 weeks following the
start of study product.
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.
4, 6 and 8 weeks following the start of study
product
To assess the effect of ReCharge on use of antidiarrhoeal medication as measured by
completion of a daily patient diary.
8 weeks after commencing ingesting the study
product
To assess the severity of CID by monitoring by
health care professionals.
Day 1 and 2, 4, 6, 8 and 12 weeks following the
start of study product.
Page 5
Key inclusion
criteria:
*Patient with 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 > 60
mL/min
Minimum Age:
18 Years
Maximum Age:
No limit
Gender:
Both males and females
Healthy volunteers?
No
Key exclusion
criteria:
*Patient’s therapeutic regimen includes
oxaliplatin *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 a therapeutic substance
Page 6
Study type:
Interventional
Purpose of the study:
Prevention
Allocation to
intervention:
Randomised controlled trial
Describe the 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.
Describe the 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:
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Assignment:
Other design features
(specify):
Type of endpoint(s):
Safety/efficacy
Page 7
Phase
Phase 2
Anticipated or actual
start date:
3/08/2009
Target sample size:
200
Recruitment status:
Open to recruitment
Page 8
Funding source:
Commercial sector/Industry
Name:
LactoPharma
Address:
LactoPharma Level 5, Fonterra Centre 9 Princes
Street Auckland 1010
Country:
New Zealand
Primary sponsor:
Commercial sector/Industry
Name:
LactoPharma Ltd
Address:
LactoPharma Level 5, Fonterra Centre 9 Princes
Street Auckland 1010
Country:
New Zealand
Secondary sponsor:
None
Name:
Address:
Country:
Other collaborator:
Page 9
Has the study received
approval from at least
one ethics committee?
Ethics Committee name:
Yes
Multi Region Ethics Committee (MREC)
Address:
Country:
New Zealand
Date of approval:
18/06/2009
HREC Number:
MEC 09/03/031
Countries of
recruitment:
Outside Australia
New Zealand
Brief summary:
ReCharge is a food supplement which contains
two milk bioactive components, milk fat and
lactoferrin. The purpose of this study is to test
the effectiveness of ReCharge in preventing
chemotherapy induced diarrhoea (CID). To find
out if ReCharge works this study compares
ReCharge ice cream (the study product) with an
inactive ice cream product (called a placebo).
The inactive ice cream looks and tastes just like
the ReCharge icecream. Participants will be
allocated to one of these two products with equal
chances of each product being the one received.
Neither the participants nor doctors will know
which product participants will be receiving.
During the study participants will complete a
daily gastrointestinal symptom diary and Quality
of Life questionnaire and dietary habits
questionnaire at study visits.
Trial website:
Presentations / publication
list:
Page 10
Contact person for public queries
Name:
Dr David Perez
Address:
Consultant Oncologist
Dunedin Hospital
201 Great King Street
Dunedin 9016
Country:
New Zealand
Tel:
+64 3 474 0999
Fax:
Email:
david.perez@otagodhb.govt.nz
Contact person for scientific queries
Name:
Arie Geursen
Address:
LactoPharma
Level 5, Fonterra Centre
9 Princes Street
Auckland 1010
Country:
New Zealand
Tel:
+64 9 374 9590
Fax:
Email:
Arie.Geursen@fonterra.com
Contact person responsible for updating information
Name:
Janie Proctor
Address:
Country:
New Zealand
Tel:
Fax:
Email:
j.proctor@auckland.ac.nz