A proposed trial using ActiFormCool® as a prophylaxis to minimise radiation skin reaction for breast patients requiring full bolus.

1. A proposed trial using ActiFormCool® as a prophylaxis to minimise
radiation skin reaction for breast patients requiring full bolus.
Author: Georgina Grant. Lead Radiographer, GenesisCare, Elstree.

2. Breast/Chestwall skin reactions.
For all breast patients:
• Radiographers assess skin reactions using the Radiation Therapy
Oncology Group (RTOG) scoring matrix.
• The RTOG scores recorded are:
- Baseline
- Weekly
- Final fraction
- Follow-up
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3. RTOG Scoring Matrix
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RTOG Score Description
RTOG 0 No visible change to skin.
RTOG 1 Faint or dull erythema. Mild tightness of skin and itching may occur.
RTOG 2 Bright erythema/dry desquamation. Sore, itchy and tight skin.
RTOG 2.5
Patchy moist desquamation, Yellow/pale green exudate. Soreness
with oedema.
RTOG 3
Confluent moist desquamation. Yellow/pale green exudate.
Soreness with oedema.
RTOG 4 Ulceration, bleeding, necrosis (rarely seen)

4. Skin Advice
All patients are given to appropriate skin care advice before, during and
after their radiotherapy. However, the loss of skin sparing effect when using
full bolus often leads to:
• Earlier onset and increased skin reaction.
• More pain and discomfort.
• Need for nursing intervention.
• Longer recovery period.
• Psychological issues.
Small centre-based audit completed comparing patients with no bolus to
those with full chestwall bolus.
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5. Eight randomly selected No Bolus patients
Bolus Dose
RTOG
Baseline
RTOG
Week 1
RTOG
Week 2
RTOG
Week 3
RTOG
Week 4
RTOG
Week 5
Final RTOG
Follow up
RTOG
NoBolus
40Gy/15# + 10Gy/5# IMRT boost 0 0 1 1 2 2
40Gy/15# + 10Gy/5# IMRT boost 0 0 0 1 1 1 1
40Gy/15# + 10Gy/5# IMRT boost 0 0 1 1 1 1
40Gy/15# + 10Gy/5# IMRT boost 0 0 1 2 2
40Gy/15# + 10Gy/5# IMRT boost 0 0 1 1 2 1
40Gy/15# + 10Gy/5# IMRT boost 0 0 1 1 1
50Gy/25# 0 0 1 1 1 2 2 2
50Gy/25# 0 0 1 2 2 2 2
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6. Eight Full Bolus patients
Bolus Dose
RTOG
Baseline
RTOG
Week 1
RTOG
Week 2
RTOG
Week 3
RTOG
Week 4
RTOG
Week 5
Final RTOG
Follow up
RTOG
FullBolus
40Gy/15# 0 0 1 2 2 2.5
40Gy/15# 0 0 2 2 2 2
40Gy/15# 0 0 2 2 2 2.5
40Gy/15# + 10Gy/5# IMRT boost 0 0 1 1 2 2 2
50Gy/25# 0 1 2 2 2 2.5 2.5
50Gy/25# 0 0 1 2 2 2.5 2.5
50Gy/25# 0 2 1 1 2.5 2.5
50Gy/25# Rt and Lt Chestwall 0 0 1 1 2 2.5 2.5 2.5
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7. ActiFormCool®.
• Decided that intervention needed to try and reduce the number of
patients developing RTOG skin toxicity score 2.5.
• BCN informed us of the product ActiFormCool®.
• Representative from the manufacturers (ActivaHealthcare) attended to
give a demonstration.
• All clinical staff impressed by the cooling effect of the product.
• Audits undertaken by radiotherapy nursing staff in a number of NHS
hospitals with good results on radiotherapy skin reactions.
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8. Ionic Sheet Hydrogel Dressing
• 70% Water
• 30% Acrylic Polymer
• Preservative - phenoxyethylene
An Ionic hydrogel responds dynamically to the condition of the wound
It can either donate or absorb fluid to maintain optimal moisture levels
Permeable to water vapour, gases and small protein molecules
Impermeable to bacteria Slide courtesy of ActivaHealthcare

9. • Reduces wound pain and improves patient comfort.
Pain Management in Leg Ulcers using ActiFormCool, Stephen Young, Sylvia
Hampton. Wounds UK Journal, November 2005.
• Dynamically responds to wound changes by donating
or absorbing moisture
• For use on dry to highly exuding wounds
• For all stages of the wound healing
• Easy to use
Slide courtesy of ActivaHealthcare

10. Service Development
Started a thought process at Elstree….
• Could this product be used to help reduce skin reaction?
• At what stage of radiotherapy should it be used?
• How would it be held in position?
• How often should it be applied?
• Could it be used as a prophylaxis?
Discussions started between GenesisCare Elstree and ActivaHealthcare
regarding a possible trial of the product.
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11. Alignment with our Visions and Values

12. The use of ActiFormCool® in this trial would meet all of the Genesiscare
Visions and Values, particularly:
Quality:
Providing the best quality available to our patients
Collaboration:
ActivaHealthcare and GenesisCare working together. Easier access to new,
innovative products.
Compassion:
To improve the patient journey by reducing pain and discomfort during and after
radiotherapy.
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Alignment with our Visions and Values

13. Innovation:
GenesisCare to be the first healthcare provider to use ActiFormCool®
prophylactically. ActivaHealthcare are excited to be part of the trial as it will be
the first of its kind.
Outcomes:
The patient will benefit from less nursing intervention following the completion
of radiotherapy. This could then be implemented as best practice throughout all
GC Centres.
• Could lead to Medical Journal publications.
• Good for increasing patient referrals.
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Alignment with our Visions and Values

14. Proposed Methodology
• Oncologists informed if their patient is involved.
• Patient consent required for the trial.
• The ActiFormCool® pad would need to be kept in position from fraction
1 until the completion of radiotherapy for 24 hours/day. Removal for
treatment and washing only.
• Patient still to apply E45 to intact skin.
Actifast® tubular retention bandages to be used to maintain cool pad
position.
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15. Proposed Methodology
• Radiotherapy Skin Reaction Evaluation form will be completed for
each patient from Baseline RTOG score to FU RTOG score.
• Daily Navigator notes and weekly RTOG scores recorded in Mosaiq.
• RTOG scores will be retrospectively compared to patients who
received full bolus without the intervention of ActiFormCool®.
ActivaHealthcare to provide all resources.
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17. Next Steps…..
• New Research Initiative Evaluation form has been completed.
• Needs to be passed by members of SMT.
• Needs to be passed by an Ethics committee.
• Hopefully start the trial in Early 2017.
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18. Thank-you