Assessing the efficacy of ice-cream-formulated iron-saturated lactoferrin and anhydrous milk fat in preventing chemotherapy induced diarrhoea – the ReCharge Study, a randomised phase IIb trial — ASN Events
  1. Schedule
  2. Best of the Best Orals - Supportive care
  3. Assessing the efficacy of ice-cream-formulated iron-saturated lactoferrin and anhydrous milk fat in preventing chemotherapy induced diarrhoea – the ReCharge Study, a randomised phase IIb trial

Assessing the efficacy of ice-cream-formulated iron-saturated lactoferrin and anhydrous milk fat in preventing chemotherapy induced diarrhoea – the ReCharge Study, a randomised phase IIb trial (#127)

Sarah Benge 1 , David Perez 2 , Katrina Sharples 1 3 , Reuben Broom 4 , Mark Jeffery 5 , Janie Proctor 1 , Victoria Hinder 1 , Stephanie Pollard 1 , Jim Edwards 6 , Andrew Simpson 6 , Michael Jameson 7 , Richard Isaacs 8 , Richard North 9 , Jade Scott 1 , Geoff Krissansen 10 , Arie Geursen 11 , Kate Palmano 11 , Dorothy Keefe 12 , Michael Findlay 1
  1. Cancer Trials New Zealand, University of Auckland, Auckland, New Zealand
  2. Medical School, University of Otago, Dunedin, New Zealand
  3. Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand
  4. Auckland Regional Cancer & Blood Service, Auckland District Health Board, Auckland, New Zealand
  5. Medical Oncology, Canterbury District Health Board, Christchurch, New Zealand
  6. Wellington Blood & Cancer Centre, Capital & Coast District Health Board, Wellington, New Zealand
  7. Medical Oncology, Waikato District Health Board, Hamilton, New Zealand
  8. Medical Oncology, Mid-Central District Health Board, Palmerston North, New Zealand
  9. Medical Oncology, Bay of Plenty District Health Board, Tauranga, New Zealand
  10. University of Auckland, Auckland, New Zealand
  11. LactoPharma, Auckland, New Zealand
  12. Cancer Medicine, University of Adelaide, Adelaide, SA, Australia

Introduction:
A medicinal food product containing iron-saturated lactoferrin and anhydrous milk fat (ReChargeTM) has been shown to reduce the effects of chemotherapy on the gut in animals. We conducted a randomised double blinded placebo-controlled Phase IIb trial to investigate the efficacy and safety of ReCharge, formulated as ice-cream, in preventing chemotherapy induced diarrhoea (CID) in patients receiving chemotherapy.

Objectives:
Primarily to determine whether ReCharge reduces the number of days a patient has CID with the incidence of diarrhoea as a key secondary measure.

Methods:
Patients (197) were randomised 1:1 to ReCharge or placebo. Patients consumed 100ml study product for 14 ± 4 days before starting chemotherapy and for 6 weeks after starting chemotherapy; they completed daily diaries for 8 weeks and attended clinic visits for 12 weeks (two-week cycles) or 14 weeks (three-week cycles).

Results:
The mean number of days with diary-recorded CID was marginally but not statistically significantly lower on ReCharge than placebo (-2.0, 95% confidence interval (-4.7 to 0.7)), (p=0.2). However the proportion reporting diarrhoea at clinic was 30% lower (p=0.012). Missing diary data may have contributed to the discrepancy.

Conclusions:
There was no clear evidence of a benefit from ReCharge in reducing CID as measured by patient self-report diary. The converse finding of benefit as measured at clinic visits (secondary endpoint) and the incomplete adherence to diary completion however indicate further research is required into optimal methods for measuring CID. 

#COSAASM