Perez, D., Sharples, K.J., Broom, R., Jeffery, M., Proctor, J., Hinder, V., . . . Findlay, M. (2015). A randomised phase IIb trial to assess the efficacy of ReCharge ice cream in preventing chemotherapy-induced diarrhoea. Supportive Care in Cancer, 23, 3307–3315. 

To assess the efficacy of ReCharge ice cream in reducing the number of days with chemotherapy-induced diarrhea (CID)

Eligible patients were randomized 1:1 to ReCharge or placebo, administered as one 11 g placebo serving or ReCarge daily for 10–18 days prechemotherapy and continued for six weeks from the start of chemotherapy.

• N = 197  
• AGE = 47–71 years
• MALES: 63.7%, FEMALES: 47.3%
• KEY DISEASE CHARACTERISTICS: All cancers
• OTHER KEY SAMPLE CHARACTERISTICS: Four weeks or more since last chemotherapy; starting first-, second-, or third-line regimen with cycles of two or three weeks; includes at least one of capecitabine, docetaxel, paclitaxel, 5-FU, or irinotecan

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: New Zealand

• PHASE OF CARE: Active antitumor treatment

• Randomized, controlled trials

• Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
• Functional Assessment of Chronic Illness Therapy-diarrhea subscale (FACIT-D)
• Primary intention to treat analysis
• Poisson regression model
• Patient diary
• Clinic assessments

The mean number of days with CID was not statistically significant on ReCharge versus placebo. There were no statistically significant differences between the treatment arms.

The study did not demonstrate effectiveness of ReCharge in reducing diarrhea.

• Risk of bias (no blinding)
• Selective outcomes reporting
• Key sample group differences that could influence results 
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Many patients accrued were not included in study

ReCharge is not effective in CID management.