Louisiana Administrative Code
Title 48 - PUBLIC HEALTH-GENERAL
Part I - General Administration
Subpart 1 - General
Chapter 23 - Informed Consent
Section I-2337 - Radiation Therapy (Radiation Oncology)
Universal Citation: LA Admin Code I-2337
Current through Register Vol. 50, No. 9, September 20, 2024
A. Head and Neck
1. Early Reactions
a. reduced and sticky saliva, loss of taste
and appetite, altered sense of smell, nausea;
b. sore throat, difficulty swallowing, weight
loss, fatigue;
c. skin changes;
redness, irritation, scaliness, blistering or ulceration, color change,
thickening, hair loss;
d.
hoarseness, cough, loss of voice and swelling of airway;
e. blockage and crusting of nasal
passages;
f. inflammation of ear
canal, feeling of "stopped-up" ear, hearing loss, dizziness;
g. dry and irritable eye(s), if the eyes or
tear glands are in the radiation beam;
h. depression of blood count leading to
increased risk of infection and/or bleeding;
i. these reactions are likely to be
intensified by chemotherapy before, during or after radiation
therapy.
2. Late
Reaction(s)
a. dry mouth and altered, or loss
sense of, taste;
b. tooth decay and
gum changes;
c. bone damage,
especially in jaws;
d. stiffness
and limitation of jaw movement;
e.
changes in skin texture and/or coloration, permanent hair loss, scarring of
skin, poor healing of surgical wounds, and death of normal tissue;
f. swelling of tissues, particularly under
the chin;
g. throat damage causing
hoarseness, pain, or difficulty breathing or swallowing;
h. eye damage causing dry eye(s), cataract,
loss of vision, or loss of eye(s), if the eye is in the radiation
beam;
i. ear damage causing dryness
of ear canal, fluid collection in middle ear, hearing loss;
j. brain, spinal cord, or nerve damage
causing alteration of thinking ability;
k. pituitary or thyroid gland damage
requiring long-term hormone replacement therapy;
l. in children, there may be additional late
reactions as follows:
i. disturbances of bone
and tissue growth;
ii. abnormal
development of facial bones;
iii.
brain damage causing a loss of intellectual ability, learning capacity, and
reduced intelligence quotient (I.Q.);
iv. second cancers developing in the
irradiated area.
B. Central Nervous System
1. Early Reactions
a. skin and scalp reaction with redness,
irritation, scaliness, blistering, ulceration, change in color, thickening,
hair loss;
b. nausea, vomiting,
headaches;
c. fatigue,
drowsiness;
d. altered sense of
taste or smell;
e. inflammation of
ear canal, feeling of "stopped-up" ear, hearing loss, dizziness;
f. depression of blood count leading to
increased risk of infection and/or bleeding;
g. these reactions are likely to be
intensified by chemotherapy before, during or after radiation
therapy.
2. Late
Reactions
a. permanent hair loss of variable
degrees, altered regrowth, texture, and color of hair;
b. persistent drowsiness and
tiredness.
c. brain damage causing
a loss of some degree of thinking ability, memory or personality changes, loss
of sensation or balance, seizures, hemorrhage, or steroid dependency due to
brain swelling, rarely, severe damage may produce paralysis or death;
d. scarring of skin;
e. spinal cord or nerve damage causing
paralysis, loss of strength, feeling, or coordination in any part of the
body;
f. damage to eye(s) or optic
nerve(s) causing loss of vision;
g.
ear damage causing dryness of ear canal, fluid collection in middle ear,
hearing loss;
h. pituitary gland
damage requiring long-term hormone replacement therapy;
i. in children, there may be additional late
reactions as follows:
i. disturbances of bone
and tissue growth;
ii. bone damage
to spine, causing stunting of growth, curvature, and/or reduction in
height;
iii. abnormal bone growth
in the face or pelvis;
iv. brain
damage causing a loss of intellectual ability, learning capacity, and reduced
intelligence quotient (I.Q.);
v.
second cancers developing in the irradiated area.
C. Thorax
1. Early Reactions
a. skin changes: redness, irritation,
scaliness, ulceration, change in color, thickening; hair loss on the
chest;
b. inflammation of esophagus
causing pain on swallowing, heartburn, or sense of obstruction;
c. loss of appetite, nausea, vomiting, weight
loss, and weakness;
d. inflammation
of the lung with pain, fever, and cough;
e. inflammation of the heart sac with chest
pain and possible decreased heart function;
f. bleeding or creation of a fistula
resulting from tumor destruction;
g. depression of blood count leading to
increased risk of infection and/or bleeding;
h. intermittent electric shock-like feelings
in the lower spine or legs on bending the neck;
i. these reactions are likely to be
intensified by chemotherapy before, during or after radiation
therapy.
2. Late
Reactions
a. changes in skin texture and/or
coloration, permanent hair loss and scarring of skin;
b. lung scarring or shrinkage causing
shortness of breath;
c. narrowing
of esophagus causing swallowing problems;
d. constriction of heart sac which may
require surgical correction;
e.
damage to heart muscle or arteries leading to heart failure or heart
attack;
f. fracture of
ribs;
g. nerve damage causing pain,
loss of strength or feeling in arms;
h. spinal cord damage causing paralysis, loss
of strength or feeling in arms and legs and/or loss of control of bladder and
rectum;
i. liver damage;
j. loss of thyroid function;
k. in children, there may be additional late
reactions as follows:
i. disturbances of bone
and tissue growth;
ii. bone damage
to spine, causing stunting of growth, curvature, and/or reduction in
height;
iii. underdevelopment or
absence of development of female breast;
iv. second cancers developing in the
irradiated area.
D. Breast
1. Early Reactions
a. skin changes: redness (sunburn-like),
irritation, scaliness, blistering, ulceration, coloration, thickening; hair
loss;
b. breast changes, including
swelling, tightness, tenderness or pain;
c. inflammation of the esophagus causing pain
on swallowing, heartburn, or sense of obstruction;
d. lung inflammation with cough;
e. inflammation of heart sac with chest pain
and possible decreased heart functions;
2. Late Reactions
a. changes in skin texture and/or coloration,
permanent hair loss and scarring of skin;
b. breast changes, including thickening,
firmness, tenderness, shrinkage, or edema (swelling);
c. swelling of arm;
d. stiffness and discomfort in shoulder
joint;
e. rib damage causing pain
or fracture;
f. nerve damage
causing pain, loss of strength or feeling in arm;
g. damage to heart muscle or heart sac
leading to heart failure;
h.
permanent scarring of the lung producing shortness of breath, cough, or
susceptibility to infection;
i.
loss of thyroid functions;
j. if
there is a cancer recurrence, mastectomy may be required.
E. Abdomen
1. Early Reactions
a. skin changes: redness, irritation,
scaliness, ulceration, change in color, thickening; hair loss;
b. loss of appetite, nausea,
vomiting;
c. weight loss, weakness,
fatigue;
d. inflammation of stomach
causing indigestion, heartburn, and ulcers;
e. inflammation of bowel causing cramping and
diarrhea;
f. depression of blood
count leading to increased risk of infections and/or bleeding;
g. these reactions are likely to be
intensified by chemotherapy before, during, and/or after radiation
therapy.
2. Late
Reactions
a. changes in skin texture and/or
coloration, permanent hair loss and scarring of skin;
b. stomach damage causing persistent
indigestion, pain, and bleeding;
c.
bowel damage causing narrowing or adhesions of bowel with obstruction,
ulceration or bleeding which may require surgical correction, chronic diarrhea,
or poor absorption of food elements;
d. kidney damage leading to kidney failure
and/or high blood pressure;
e.
liver damage leading to liver failure;
f. spinal cord or nerve damage causing
paralysis, loss of strength or feeling in legs and/or loss of control of
bladder and/or rectum;
g. these
reactions are likely to be intensified by chemotherapy in a patient who is
receiving, has received, or will receive radiation therapy:
F. Female Pelvis
1. Early Reactions
a. inflammation of bowel causing cramping,
diarrhea, nausea, vomiting, and/or decreased appetite;
b. inflammation of rectum and anus causing
pain, spasm, discharge, bleeding;
c. bladder inflammation causing burning,
frequency, spasm, pain, bleeding;
d. skin changes: redness, irritation,
scaliness, blistering or ulceration, coloration, thickening; hair
loss;
e. disturbance of menstrual
cycle;
f. vaginal discharge, pain,
irritation, bleeding;
g. depression
of blood count leading to increased risk of infection and/or
bleeding;
h. these reactions are
likely to be intensified by chemotherapy before, during or after radiation
therapy.
2. Late
Reactions
a. bowel damage causing narrowing
or adhesions of the bowel with obstruction, ulceration, bleeding, chronic
diarrhea, or poor absorption of food elements and may require surgical
correction or colostomy;
b. bladder
damage with loss of capacity, frequency of urination, blood in urine, recurrent
urinary infections, pain, or spasm which may require urinary diversion and/or
removal of bladder;
c. changes in
skin texture and/or coloration, permanent hair loss, scarring of
skin;
d. bone damage leading to
fractures;
e. ovarian damage
causing infertility, sterility, premature menopause, or genetic damage to
future offspring;
f. vaginal damage
leading to dryness, shrinkage, pain, bleeding, or sexual dysfunction;
g. swelling of the genitals or
legs;
h. nerve damage causing pain,
loss of strength or feeling in legs, and/or loss of control of bladder or
rectum;
i. fistula between the
bladder and/or bowel and/or vagina;
j. pelvic fibrosis producing obstruction of
bowel or ureters;
k. in children,
there may be additional late reactions as follows:
i. disturbances of bone and tissue
growth;
ii. bone damage to pelvis
and hips causing stunting of bone growth and/or abnormal development;
iii. second cancers developing in the
irradiated area.
G. Male Pelvis
1. Early Reactions
a. inflammation of bowel causing cramping,
diarrhea, nausea, vomiting, and/or decreased appetite;
b. inflammation of rectum and anus causing
pain, spasm, discharge, bleeding;
c. bladder inflammation causing burning,
frequency, spasm, pain and/or bleeding;
d. skin changes: redness, irritation,
scaliness, blistering or ulceration, coloration, thickening; hair
loss.
e. depression of blood count
leading to increased risk of infection and/or bleeding;
f. these reactions are likely to be
intensified by chemotherapy before, during or after radiation
therapy.
2. Late
Reactions
a. bowel damage causing narrowing
or adhesions of the bowel with obstruction, ulceration, bleeding, chronic
diarrhea, or poor absorption of food elements and may require surgical
correction or colostomy;
b. bladder
damage with loss of capacity, frequency of urination, blood in urine, recurrent
urinary infections, pain, or spasm which may require urinary diversion and/or
removal of bladder;
c. changes in
skin texture and/or coloration, permanent hair loss, scarring of
skin;
d. bone damage leading to
fractures;
e. testicular damage
causing reduced sperm counts, infertility, sterility, or risk of birth
defects;
f. impotence (loss of
erection) or sexual dysfunction;
g.
swelling of the genitalia or legs;
h. nerve damage causing pain, loss of
strength or feeling in legs, and/or loss of control of bladder or
rectum;
i. fistula between the
bowel and other organs;
j. pelvic
fibrosis producing obstruction of bowel or ureters;
k. in children, there may be additional late
reactions as follows:
i. disturbances of bone
and tissue growth;
ii. bone damage
to pelvis and hips causing stunting of bone growth and/or abnormal
development;
iii. second cancers
developing in the irradiated area.
H. Skin
1.
Early Reactions
a. redness, irritation, or
soreness;
b. scaliness, ulceration,
crusting, oozing, discharge;
c.
hair loss;
d. these reactions are
likely to be intensified by chemotherapy.
2. Late Reaction(s)
a. changes in skin texture causing scaly or
shiny smooth skin, thickening, with contracture, puckering, scarring of
skin;
b. changes in skin color or
overall appearance;
c. prominently
dilated small blood vessels;
d.
loss of sweating in treated area;
e. permanent hair loss;
f. chronic or recurrent ulcerations, severe
damage may require skin grafting or plastic surgery;
g. damage to adjacent tissues, including
underlying bone or cartilage;
h.
possible injury may occur from trauma, sun, or frostbite unless the treated
area is forever protected;
i. in
children, second cancers may develop in the irradiated area.
I. Extremities
1. Early Reactions
a. skin changes: redness, irritation,
scaliness, ulceration, coloration, thickening; hair loss;
b. inflammation of soft tissues causing
tenderness, swelling, and interference with movement;
c. inflammation of joints causing pain,
swelling and limitation of joint motion;
d. these reactions are likely to be
intensified by chemotherapy before, during or after radiation
therapy;
e. depression of blood
counts leading to increased risk of infection and/or bleeding.
2. Late Reactions
a. changes in skin reaction and/or
coloration, permanent hair loss, and scarring of the skin;
b. scarring or shrinkage of soft tissues and
muscle causing loss of flexibility and movement, swelling of the
limb;
c. nerve damage causing loss
of strength, feeling, or coordination;
d. bone damage causing fracture;
e. joint damage causing permanent stiffness,
pain, and arthritis;
f. swelling of
limb below the area treated;
g. in
children, there may be additional late reactions as follows:
i. disturbances of bone and tissue
growth;
ii. bone damage to limbs
causing stunting of bone growth and/or abnormal development;
iii. second cancers developing in the
irradiated area.
J. Total Body Irradiation
1. Early Reactions
a. loss of appetite, nausea,
vomiting;
b. diarrhea;
c. reduced and sticky saliva, swelling of the
salivary gland(s), loss of taste;
d. hair loss;
e. sore mouth and throat, difficulty
swallowing;
f. permanent
destruction of bone marrow leading to infection, bleeding, and possible fatal
lung failure;
g. inflammation of
the lung with fever, dry cough and difficulty breathing with possible fatal
lung failure;
h. damage to liver
with possible fatal liver failure;
i. depression of blood counts leading to
increased risk of infection and/or bleeding;
j. these reactions are likely to be
intensified by chemotherapy before, during or after radiation
therapy.
2. Late
Reactions
a. lung scarring causing shortness
of breath, infection, and fatal lung failure;
b. cataract formation in the eyes, possible
loss of vision;
c. testicular
damage in males causing sterility;
d. ovarian damage in females causing
premature menopause and sterility;
e. increased risk of second cancer;
f. decreased ability to give further
chemotherapy or other cancer treatment.
K. Endobronchial Radiation
1. Early Reactions
a. a mild sore throat;
b. some difficulty in swallowing;
c. bleeding;
d. infection or pneumonia.
2. Late Reactions
a. damage to spinal cord possibly producing
paralysis;
b. lung
scarring;
c. hemorrhage (possibly
fatal);
d. inflammation of heart
sac;
e. fistula (opening between
bronchial tree and lung and/or esophagus);
f. pneumothorax (collapse of lung);
g. abscess formation;
h. death.
AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1299, 40E et seq.
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