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.
Registration number:
|
ACTRN12609000163202 |
Ethics number:
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MEC/09/03/031
|
ReCharge is a food supplement which contains two milk bioactive components, milk
fat and lactoferrin. Animal studies of chemotherapy-induced diarrhea (CID) suggest
that ReCharge has a protective effect
on the lining of the intestine. Lactoferrin
occurs naturally in milk and contains iron.
The purpose of this study is to test the effectiveness of ReCharge in preventing
chemotherapy induced diarrhoea.
To find out if ReCharge works this study compares ReCharge ice cream (the investigational
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.
Participants will be asked to eat a standard tub (100g) of
the study ice-cream every day for a total of 8 weeks, starting 2 weeks before chemotherapy
and for the first 6 weeks of chemotherapy.
200 patients from across New Zealand are needed for the trial.
If you would like more information please contact:
Latest update
Talk to your oncologist for further information about participating in this trial.
Detailed information available here
ReCharge in the media:
Womens Weekly 17/05/2010(1.5MB PDF)
BOPT 27/04/2010(96.1KB PDF)
TVNZ, TV3, TV3
Progress
This trial closed to recruitment on the 27th April 2012.
Results
None to date.
Centres involved
The New Zealand centres participating in this study are:
-
Auckland
- Tauranga
- Waikato
- Palmerston North
- Wellington
- Christchurch
- Dunedin (Lead centre)
