Caphosol

Caphosol

PEP Topic 
Mucositis
Description 

Caphosol is a calcium phosphate solution resembling human saliva that is intended to replace the normal ionic and pH balance in the oral cavity. It has been used as a mouth rinse to moisten, lubricate, and clean the oral mucosa, tongue, and throat. Caphosol has been evaluated for mucositis.

Effectiveness Not Established

Research Evidence Summaries

Papas, A.S., Clark, R.E., Martuscelli, G., O’Loughlin, K.T., Johansen, E., & Miller, K.B. (2003). A prospective, randomized trial for the prevention of mucositis in patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplantation, 31, 705–712.

doi: 10.1038/sj.bmt.1703870
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Intervention Characteristics/Basic Study Process:

Patients rinsed with 30 ml of calcium phosphate at least four times per day. Patients also received four topical treatments of 1% fluoride as neutral 2% sodium fluoride gel administered by tray at the screening visit and completed prior to hospitalization.

Patients in the control group received an aqueous 0.01% sodium fluoride rinse. Prior to transplantation, the control group received four topical treatments with a placebo gel administered with the same technique as the experimental group. During transplantation, patients used the sodium fluoride rinse at least four times daily, 30 ml each time.

Patients who developed severe mucositis were instructed to rinse up to 10 times per day with their solution.

All patients received acyclovir and antifungal prophylaxis per protocol.

Sample Characteristics:

  • The study reported on 95 patients undergoing hematopoietic stem cell transplantation (HSCT).
  • Patients receiving autologous HSCT had peripheral stem cells and granulocyte colony-stimulating factor (G-CSF).
  • Patients receiving allogenic HSCT had bone marrow cells and methotrexate (MTX).
  • The experimental group had 50 patients, and the control group had 47 patients.

Study Design:

This was a randomized, controlled trial.

Measurement Instruments/Methods:

The National Institute of Dental and Craniofacial Research scale was used.

The following were measured and recorded.

  • Days to absolute neutorphile count (ANC) greater than 200 mm3
  • Days to ANC greater than 500 mm3
  • Days of mucositis
  • Peak mucositis level
  • Peak pain level
  • Days of pain
  • Milligrams of self-administered morphine
  • Days of morphine
  • Average length of stay (ALOS)

Results:

  • Duration of mucositis was 7.2 days in the control group and 3.72 days in the caphosol group (p = 0.00096).
  • The control group had a smaller percentage of patients experiencing no mucositis (19% versus 40%).
  • Peak mucositis was significantly higher for the control group (p = 0.004).
  • The experimental group experienced fewer days of pain, milligrams of morphine, and days of morphine.

Conclusions:

  • The study had an adequate sample size according to power analysis.
  • Frequency, duration, and severity of oral inflammatory processes were significantly lower in the experimental group.

Limitations:

  • Use of fluoride may have decreased infection.
  • No comparison was provided between allogeneic and autologous transplantations and the presence of mucositis.

Pettit, L., Sanghera, P., Glaholm, J., & Hartley, A. (2014). The use of MuGard™, Caphosol® and Episil® in patients undergoing chemoradiotherapy for squamous cell carcinoma of the head and neck. Journal of Radiotherapy in Practice, 13(2), 218–225.

doi: 10.1017/S1460396912000581
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Study Purpose:

To record mucositis and dysphagia toxicity and level of anesthesia for patients receiving MuGard, Caphosol, or Episil in comparison to standard care

Intervention Characteristics/Basic Study Process:

Patients undergoing concurrent radiotherapy and chemotherapy for locally advanced head and neck cancer were audited for eight weeks during treatment. Patients were sequentially given either the standard oral care regimen of aspirin, glycerin, and sucralfate and Gelclair® or one of the other products. Patients were assessed weekly during four weeks of radiotherapy and for four weeks after completion. All patients received the same protocol approach for analgesia.

Sample Characteristics:

  • N = 104  
  • AGE: Not reported
  • MALES: Not reported, FEMALES: Not reported
  • KEY DISEASE CHARACTERISTICS: All had squamous cell head and neck cancer, most were of the oropharynx. All were receiving concurrent carboplatin or cetuximab. Radiotherapy was 55 Gy in 20 fractions over 25 days.

Setting:

  • SITE: Single site 
  • SETTING TYPE: Outpatient 
  • LOCATION: United Kingdom

Phase of Care and Clinical Applications:

PHASE OF CARE: Active antitumor treatment

Study Design:

Observational

Measurement Instruments/Methods:

Common Terminology Criteria for Adverse Events v3

Results:

No differences were seen between groups in average grade of dysphagia or analgesia use. No differences were seen between those receiving radiotherapy with intensity-modulated radiation therapy or conformal radiotherapy.

Limitations:

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results
  • A much larger group of patients was in the standard care group. No information is provided about general oral care, and frequency of use of any of the oral agents is not described. Adherence varied considerably across groups, with the largest adherence to the standard care regimen.

Nursing Implications:

This study had numerous design limitations and provides little supportive evidence for any of the approaches used for prevention and management of oral mucositis or associated pain.

Svanberg, A., Ohrn, K., & Birgegard, G. (2015). Caphosol mouthwash gives no additional protection against oral mucositis compared to cryotherapy alone in stem cell transplantation. A pilot study. European Journal of Oncology Nursing, 19, 50–53. 

doi: 10.1016/j.ejon.2014.07.011
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Study Purpose:

To determine whether the addition of Caphosol® mouth rinse to a standard of care that included oral cryotherapy would decrease the incidence of oral mucositis

Intervention Characteristics/Basic Study Process:

Patients were randomized with a computer table to the experimental or the control group. All patients received oral cryotherapy (crushed ice in the mouth during treatment), but only the experimental group received Caphosol®. Patients in the experimental group used Caphosol® 30 mL to rinse the oral cavity four times per day starting before high-dose chemotherapy and ending on day 21. Data were collected daily from the start of chemotherapy till day 21.

Sample Characteristics:

  • N = 40  
  • MEAN AGE = 50.4 years
  • MALES: 23, FEMALES: 17
  • KEY DISEASE CHARACTERISTICS: Hematologic malignancies including acute myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, chronic myelomonocytic leukemia, and myelodysplastic syndrome
  • OTHER KEY SAMPLE CHARACTERISTICS: There were no significant differences between the conditioning regimes of the two groups.

Setting:

  • SITE: Single-site    
  • SETTING TYPE: Inpatient    
  • LOCATION: University Hospital, Sweden

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment

Study Design:

Randomized, controlled, open-label study

Measurement Instruments/Methods:

  • World Health Organization (WHO) mucositis grading
  • Pain was assessed using the Visual Analog Scale (VAS).
  • Pain medications, C-reactive protein (CRP) values, lab values, number of total parenteral nutrition (TPN) days, and hospital days were obtained from medical records.

 

Results:

There was no statistically significant difference between the mucositis scores, oral pain, days with TPN, use of opioids, number of hospital days, or lab values.

Conclusions:

Adding Caphosol® to oral cryotherapy did not provide any additional effects.

Limitations:

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Other limitations/explanation: In the experimental group, 15% of patients discontinued the intervention.

Nursing Implications:

Oral mucositis continues to be a major complication of chemotherapy, particularity high-dose chemotherapy. Additional research with larger sample sizes is suggested because of a trend of lower pain levels, mucositis scores, and use of analgesics in patients using Caphosol®. The 21-day use of Caphosol® and the discontinuation of Caphosol® because of taste or nausea are other items that merit additional study.


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