3. An Adverse Event
Is any unfavourable and unintended sign (including an abnormal
laboratory finding), symptom, or disease temporally associated
with the use of a medical treatment or procedure that may or
may not be considered related to the medical treatment or
procedure
4. Early, or acute, effects Late, or chronic effects
An Adverse event
5. Early, or acute, effects
⢠Occur within a few days or weeks of irradiation .
⢠In tissues with a rapid rate of turnover.
⢠Examplesď in the epidermal layer of the skin, gastrointestinal
epithelium, and hematopoietic system,
⢠The time of onset of early reactions correlates with the relatively
short life span of the mature functional cells
6. Late, or chronic effects
⢠Appear after a delay of months or years and occur predominantly in
slowly proliferating tissues, such as tissues of the lung, kidney,
heart, liver, and central nervous system.
⢠Fibrosis of stromal tissues
⢠Sclerosis of blood vessels
⢠Atrophy of epithelial tissues including parenchymal and glandular
organs
⢠consequential late effect
8. Grade
Refers to the severity of the adverse events
⢠Grade 0 No symptoms
⢠Grade 1 Mild
⢠Grade 2 Moderate
⢠Grade 3 Severe
⢠Grade 4 Life-threatening
⢠Grade 5 Death
9. CTCAE
⢠First developed in 1990
⢠Formally called common toxicity criteria
⢠Uses MedDRA terminology (The Medical Dictionary for Regulatory
Activities)
⢠Incorporates activities of daily living (ADL)
ďą instrumental ADL
ďą Self care ADL
10. ⢠Grade 1 Mild; asymptomatic or mild symptoms; clinical or
diagnostic observations only; intervention not indicated.
⢠Grade 2 Moderate; minimal, local or noninvasive intervention
indicated; limiting age-appropriate instrumental ADL*.
⢠Grade 3 Severe or medically significant but not immediately life-
threatening; hospitalization or prolongation of hospitalization
indicated; disabling; limiting self care ADL**.
⢠Grade 4 Life-threatening consequences; urgent intervention
indicated.
⢠Grade 5 Death related to AE.
11.
12. RTOG/EORTC Radiation toxicity criteria
⢠First published in 1983
⢠Specifically adapted to radiation treatment effects
⢠Used in RTOG and NRG Oncology studies
Late morbidity scoring criteria Acute radiation morbidity scoring criteria
RTOG Toxicity
criteria
13.
14. LENT SOMA Scale
⢠Improve the recording so that there can be uniform reporting of
toxicity,
18. General Precautions for skin before RT
Doâs
⢠Cleanse daily gently
⢠Moisturize the skin
⢠Protect the radiated site from sun
exposure
⢠Monitor weight during treatment
⢠Good nutrition
⢠Remove all dressings or creams before
RT
⢠Clean with normal saline or a
noncytotoxic wound cleanser
⢠Remove any necrotic tissue
Donâts
⢠Rub, put pressure on, or scratch
radiated area
⢠Wear loose clothes
⢠Take hot water showers
⢠Use a razor in the radiation site Apply
astringents, facial toners, after shave
the radiation site
⢠Use drying agents to the skin unless
instructed
⢠Use any tape or adhesives on the
radiated skin
⢠Antimicrobial wound cleansers
19. Week Skin Reaction Reaction Type Management
1 and 2 No reaction Rationale:
To promote hydrated skin &
maintain skin integrity
Mx
To apply aqueous cream initially
twice daily
3 Mild hyperpigmentation
with mild erythema
Rationale:
To promote hydrated skin, patient
comfort and maintain skin
integrity. To treat itchy skin. To
reduce pain, soreness and
discomfort
Mx
Increase application of aqueous
cream as needed. 1%
Hydrocortisone cream may also be
prescribed for symptomatic relief.
Commence analgesia as guided by
WHO analgesic ladder
20. Week Skin Reaction Reaction Type Management
6 Progressive erythema
and hyperpigmentation
with areas of dry
desquamation
Rationale::
To promote hydrated skin, patient
comfort and maintain skin
integrity. To treat itchy skin. To
reduce pain, soreness and
discomfort
Mx
- Continue same as previous
7 Moist desquamation
along the neck fold
Rationale:
To promote comfort. Reduce risk
of complications of further trauma
and infection. To reduce pain,
soreness and discomfort
Mx
- Continue aqueous cream on
unbroken skin.
- Stop hydrocortisone on broken
skin.
- Apply an appropriate dressing
to exuding areas (e.g.
PolyMem, Mepilex, Allevyn
N.A.
- Analgesia as guided by WHO
analgesic ladder.
21. Week Skin Reaction Reaction Type Rationale:
8 Confluent dry and
resolving moist
Desquamation (with the
formation of new skin
islands)
Rationale::
To promote comfort reduce risk of
complications of further trauma and
infection
Mx
- Give radiation break can be
considered
- Stop using aqueous cream on
moist/broken skin.
- Apply Aquacel Ag/ Algicel
Ag/Mepitel Ag
- Avoid agents that will dry the
skin (Domeboro, aloe vera)
- Not to use Gentian violet
10 weeks
Post RT
completion
Induration with residual
hyperpigmentation and
resolving erythema of
the radiation site
Rationale:
Mx
- Continue to moisturize the area
one to two times a day
- Continue to apply sunscreen and
protect the area when exposed to
direct sunlight as this can prolong
the Hyperpigmentation
- Consider pentoxifylline and
vitamin E for fibrosis prevention
22. Week Skin Reaction Reaction Type Management
Hemorrhage - Stop RT
- Surgical Intervention
Consequential late
effects
23. Week Skin Reaction Reaction Type Management
1 No reaction Rationale:
To promote hydrated skin
& maintain skin integrity
Mx
To apply aqueous cream
initially twice daily
2 No reaction
24. Week Skin Reaction Reaction Type Management
3 Hyperpigmentation
and early erythema in
the inframammary fold
Rationale:
To promote hydrated skin,
patient comfort and maintain
skin integrity. To treat itchy
skin. To reduce pain, soreness
and discomfort
Mx
- Increase application of
aqueous cream as needed.
- 1% Hydrocortisone cream
may also be prescribed for
symptomatic relief.
- Commence analgesia as
guided by WHO analgesic
ladder
4 Erythema most prominent
in the inframammary fold
and axilla with
hyperpigmentation
25. Week Skin Reaction Reaction Type Management
5 Ccombination of
early moist, dry
desquamation, and
hyperpigmentation
Rationale:
To promote comfort. Reduce risk of complications
of further trauma and infection. To reduce pain,
soreness and discomfort
Mx
- Continue aqueous cream on unbroken skin.
- Stop hydrocortisone on broken skin.
- Apply an appropriate dressing to exuding areas
(e.g. PolyMem, Mepilex, Allevyn N.A.
- Analgesia as guided by WHO analgesic ladder.
Wet desquamation;
evidence of peeling
has occurred
Rationale:
To promote comfort Reduce risk of complications
of further trauma and infection
Mx
- Give radiation break
- Stop using aqueous cream on
moist/broken skin.
- Apply Aquacel Ag/ Algicel Ag/Mepitel Ag
- Avoid agents that will dry the skin (Domeboro,
aloe vera)
- Not to use Gentian violet
Necrosis, wet
desquamation,
infection
- Stop RT
- Surgical Intervention
26. Week Skin Reaction Reaction Type Management
1 week post
radiation
Dry desquamation;
evidence of peeling
has occurred
Rationale:
Mx
- Continue to moisturize the
area one to two times a day
- Continue to apply sunscreen
and protect the area when
exposed to direct sunlight as
this can prolong the
Hyperpigmentation
- Consider pentoxifylline and
vitamin E for fibrosis
prevention
2 weeks
post
radiation
Resolution of
desquamation and
resolving of
hyperpigmentation
27. Prevention of radiation induced oral mucositis
⢠Dental prophylaxis
⢠Good oral hygiene
⢠Plenty of fluids
⢠Soft diet
⢠No smoking or alcohol
⢠Minimize denture use
⢠Radiation shields
⢠IMRT/VMAT
⢠Alcohol-containing chlorhexidine mouth rinse should be
avoided
28. Week Skin Reaction Reaction Type Management
2 Aphthous ulcerations and
mild erythema
Rationale:
To keep mouth hydrated and avoid
irritants
Mx
Oral Prophylaxis
3-4 Patchy mucositis Rationale:
To supplement healing process
and avoid further damage
Mx
- Semisolid diet
- Benzydamine hydrochloride/
betadine mouthrinse
- oral suspension of L-
glutamine
- Pain management as per
WHO analgesic ladder
- Ice chips
- Local anaesthetic sprays
29. Week Skin Reaction Reaction Type Management
6-7 Confluent mucositis Rationale::
To promote healing, avoid further
damage and prevent infection
Mx
- Stop RT
- Liquid diet/ RT feed
- Avoid salty and spicy food
- Continue as before
- Paste of antimicrobial and
antifungal agents or brilacidin-
OM, an oral rinse formulation
Tissue necrosis and
spontaneous bleeding
Surgical intervention
- FJ Feed
After 2nd pointIn which the response is determined by a hierarchical cell lineage composed of stem cells and their differentiating offspring.
If the stem cell population are depleted below levels needed for tissue restoration(tissue rescue unit) ď consequential late effect.
The International Conference on Harmonisation of Technical Requirements (ICH) orldwide by regulatory authorities, pharmaceutical companies, clinical research organisations and health care professionals allows better global protection of patient health.
Antimicrobial wound cleansers should be avoided as they are frequently cytotoxic and antimitotic and will inhibit fibroblast and keratinocyte activity needed for cellular Regeneration
For cleansing an open wound, normal saline or a noncytotoxic wound cleanser is preferred over tap water, as the quality, contaminant level, and levels of chlorine and fluorine additives in tap water are variable
Necrotic tissue in particular should be removed
as it is a source of bacterial proliferation