Falls: Descriptive Rates and Circumstances in Age-Unspecified Patients with Locally Advanced Esophageal Cancer

Abstract

Purpose.

Falls can occur in older cancer patients, but few studies have examined falls in an age-unspecified group of patients with locally advanced esophageal cancer. Because these patients are often administered neuropathy-inducing agents, are weak, and can develop orthostatic symptoms, examining falls appears relevant.

Methods.

Electronic medical records were used to examine falls and their circumstances in locally advanced esophageal cancer patients treated with chemotherapy and radiation and often surgery.

Results.

Among 300 patients, 62 (21%) suffered a fall, yielding 6 falls per 100 patient years. The median age at first fall was 64 years (range 31 to 83). The median time from cancer diagnosis to first fall was 11 months (range 0 to 107). Forty-two patients (68%) who fell had active cancer; 20 (32%) were cancer-free. Fall-related injuries occurred in 42 patients and included fractures, hematomas, and other musculoskeletal events. Eighteen patients (29%) fell repeatedly. Neuropathy, general weakness, and orthostatic symptoms were associated with falls (“He does state his neuropathy is more bothersome.… He did have a fall last week ” “He has been increasingly weak to the point where he fell down last week.…” “Upon rising… [he] felt like somebody had put a sheet over his eyes, felt very lightheaded, and fell to the floor. …”). At times, falls occurred under commonplace circumstances, such as slipping on ice or tripping on an underfoot pet.

Conclusion.

Regardless of patient age, clinicians should remain vigilant for fall risk in adult patients with locally advanced esophageal cancer.

INTRODUCTION

Falls can result in fractures, soft tissue injury, hemorrhage, pain, debility, nursing home placement, fear of falling again, poor quality of life, and sometimes even death. The magnitude of the problem of falls and their negative impact is captured in the statistic that $50 billion healthcare dollars are expended each year in the United States for the management of the trauma and incapacitation that occur from these untoward events [1].

In the setting of cancer, the study of falls has largely focused on geriatric patients. Although reported fall rates vary in the published literature, it appears that approximately 20% of geriatric cancer patients recall having fallen in the preceding 6 months [2]. However, regardless of age, many cancer patients remain at risk for development of chemotherapy-induced numbness, loss of muscle mass and strength, and, at times, orthostatic symptoms from cancer therapy – all of which contribute to a risk for falling. Hence, it appears important to examine falls and their surrounding circumstances in an age-unspecified group of adult patients.

Risk factors for falls appear to be particularly germane to patients with locally advanced esophageal cancer, a malignancy that has manifested an increasingly younger age predisposition in recent years [3]. In line with the foregoing, patients with this malignancy are typically administered neuropathy-inducing antineoplastic agents, such as cisplatin, paclitaxel, oxaliplatin; often lose weight and manifest weakness even prior to cancer diagnosis; and, as a result of directed therapy to the esophagus, can struggle with poor oral intake and orthostatic symptoms. Thus, patients with this malignancy, some of whom are younger, might be at risk for falls. It therefore appeared important to examine fall incidence in patients with this type of cancer and to understand the circumstances surrounding each reported fall.

METHODS

Overview.

The Mayo Clinic Institutional Review Board (IRB) approved the current study which was subsumed under a larger investigation that sought to understand causes of morbidity and mortality in patients with locally advanced esophageal cancer. This was a single institution study conducted at the Mayo Clinic in Rochester, Minnesota. Its primary objective was to estimate the frequency of falls in this patient population and to probe into the circumstances surrounding these events.

Patient Eligibility.

All patients had been diagnosed with locally advanced esophageal cancer and received potentially curative therapy with concurrent chemotherapy and radiation followed potentially by surgery between the years of 1997 through 2011. The study team non-randomly selected the medical records of patients from a list of several hundred who met the above inclusion criteria and who appeared representative of the group as a whole based on time of cancer diagnosis within this15-year interval.

Medical Record Review.

All records were reviewed for patient demographics, cancer characteristics, specifics about cancer treatment as well as fall episodes.

To capture fall episodes, a keyword search was undertaken with iterations of the term “fall” (“fall,” “falls,” “fell,” and “fallen”). Each medical record that included such a key word was flagged for a potential fall episode. A member of the study team (DSC) reviewed each flagged medical record to confirm the actual fall event. The medical records of patients who had suffered a fall were then reviewed in detail by this same team member to capture proximate morbidity from the fall and to document wording from the medical record to shed light on the circumstances that appeared to give rise to the fall. Other team members reviewed the medical record verbiage to confirm the categorization of circumstances surrounding these falls.

Sample Size and Data Reporting.

A sample size of 300 was chosen because it exceeds that reported in several previous studies and because it allowed for the reporting of 95% confidence intervals that would conservatively flank a given percentage by 10% or less [7–9]. Because of time varying confounding, competing risks within this group of patients, and relatively uniform therapy among patients within this group, data are presented as averages, ranges, standard deviations proportions with 95% confidence intervals, and number of events per total time during which all patients were at risk. Histograms and Kaplan Meier curves were constructed with JMP®Pro, version 14.1.0 (SAS Institute, Cary, North Carolina USA).

RESULTS

Demographics.

Within this group of 300 patients, the mean age at cancer diagnosis was 62 years (range 28-88 years; standard deviation 10 years). As mentioned above, all patients had received combined modality chemotherapy and radiation; the majority received a chemotherapy agent, such as cisplatin, paclitaxel, or oxaliplatin, all of which are known to cause neuropathy (Table 1).

Table 1:

Patient, Tumor, and Treatment Characteristics

	With fall(s) n= 62 (%)	No fall n= 238 (%)
Age at cancer diagnosis, in years (range)*	62.9 (28, 81)	61.4 (36, 88)
Gender
male	50 (81)	199 (84)
female	12 (19)	39 (16)
Cancer histology
adenocarcinoma	50 (81)	215 (90)
squamous cell carcinoma	11 (18)	22 (9)
other	1 (1)	1 (1)
Treatment modalities
chemotherapy + radiation + esophagectomy	47 (76)	182 (77)
chemotherapy + radiation	15 (24)	56 (23)
Initial chemotherapy
cisplatin/5-fluorouracil	43 (69)	174 (73)
carboplatin/paclitaxel	5 (8)	21 (9)
oxaliplatin/5-fluorouracil	4 (7)	13 (6)
other	10 (16)	30 (12)

^*Numbers in parentheses denote percentages within each group unless otherwise noted.

Falls.

Sixty-two patients (21%; 95% confidence interval of 16%, 26%) experienced a fall after cancer diagnosis (Table 1), yielding 6 falls per 100 patient years. The median age of patients who fell for the first time was 64 years (range 31 to 83 years) (Figure 1), and approximately half (n=33) who fell were < 65 years of age at the time of first fall.

Figure 1:

The median age of patients who fell for the first time was 64 years (range 31 to 83 years).

The median time to initial fall was 11 months (range 0 to 107 months) from cancer diagnosis (Figure 2). Forty-two patients (68%) who fell had active cancer, but 20 (32%) appeared cancer-free. Similarly, 24 (39%) were receiving cancer treatment at the time of their initial fall whereas 38 (61%) were off cancer therapy. Eighteen patients (29%) who fell went on to suffer another fall.

Figure 2:

In the 62 patients who sustained a fall, the time-to-first fall from cancer diagnosis was 11 months (range 0 months to 107 months).

Fall Morbidity.

Twenty five patients (40%) were evaluated or treated in an emergency department and/or hospital shortly after the fall. Fall-related injuries include fractures, hematomas, and other musculoskeletal events that occurred in the majority who fell (n=42); (68%) (Table 2). Although most fall-related injuries occurred in patients who were >/= 65 years of age, this was not always the case; 11 such injuries occurred in patients < 65 years of age. For example, a 59 year old woman who had been treated with cisplatin-based chemotherapy earlier in the year lost her balance when she stood and fractured her femoral neck. As another example, shortly after a year from cancer diagnosis, a 53 year old man who had received cisplatin-based chemotherapy developed light-headedness upon standing, fell, and developed a large abdominal wall hematoma. As a final example, a 50 year old man had received oxaliplatin-based chemotherapy, and, within approximately 4 months from cancer diagnosis, felt light-headed, fell, and fractured a rib.

Table 2:

Fall Morbidity (n=42)

Morbidity	Number of Events*
Fracture	15 (24)
upper extremity	3 (5)
lower extremity	6 (10)
spinal (compression)	3 (5)
rib	4 (6)
Bleeding complication
liver subcapsular hematoma with hemoperitoneum	1 (2)
splenic hematoma	1 (2)
abdominal wall hematoma	1 (2)
scapular hematoma	1 (2)
head contusion	1 (2)
Musculoskeletal injury
shoulder dislocation	1 (2)
rotator cuff tear/injury	3 (5)
shoulder injury unspecified	2 (3)

^*Each event was specific to a patient. Numbers in parentheses are percentages, and the denominator is representative of all patients who fell.

Falls and Circumstances Surrounding Them.

The circumstances surrounding falls clustered into four categories (Table 3), as formulated after the data had been gathered. First, falls occurred in the context of neurologic symptoms, such as neuropathy or balance problems, “He does state his neuropathy is more bothersome.… He did have a fall last week.….” Second, falls were sometimes a result of generalized weakness and debility, “He notes he has been increasingly weak to the point where he fell down last week because his legs would not support him. …” Third, patients reported a fall that was preceded by orthostatic symptoms, “Upon rising from the sitting to the standing position, a few seconds later … [he] felt like somebody had put a sheet over his eyes, felt very lightheaded, and fell to the floor … [Later] when he attempted to get out of bed, he felt very lightheaded and fell to the floor [again].” Lastly, a miscellaneous category included unspecified fall etiology, effects of non-chemotherapy medications, and the more typical reasons for falling, such as slipping on ice, losing footing in the bathtub, tripping on stairs, or tripping over an underfoot pet.

Table 3:

Medical Record Documentation

FALL ETIOLOGY	DIRECT VERBIAGE FROM THE MEDICAL RECORD
NEUROLOGIC SYMPTOMS (primarily neuropathy or balance problems)	“He tends to fall backwards … He often has to tell his legs what to do, but they don’t do it.” “He does continue to report numbness and tingling in his feet, much more his left than his right, as well as in his right hand more than his left…He had a number of falls and fractures.” “The patient now notes 3 weeks of unsteadiness, clumsiness, right-sided weakness, headache, and a tendency to fall. [H]e had progressive gait instability.” “[The patient had] symptoms of headache, vomiting, poor motor skills, and poor po intake. She was admitted to the hospital and actually sustained a fall in the hospital prompting brain imaging, and this revealed metastasis.” (In a patient with brain metastases): “He did have an episode that appeared to be consistent with some seizure activity where he felt shaky and fell … Nausea, vomiting, sedation, sleepiness, and falls are better since our last meeting.” “He does state his neuropathy is more bothersome to him. He did have a fall last week and is having some difficulty with fine motor skills.” “[The patient reports] headache, nausea, vomiting, and ataxia … He had difficulty with balance while standing and had major difficult with ambulation.” “[She] lost her balance when she stood up quickly.” “He remembers feeling off-balance as he was walking … Apparently balance is a problem.” “He does report feeling tired and his strength [was] less … He had completely lost his balance.” “At baseline, she has difficulty with her balance due to weakness which is an ongoing, chronic issue for her given her multiple comorbidities.”
GENERALIZED WEAKNESS	“He notes he has been increasingly weak to the point where he fell down last week because his legs would not support him … His legs gave out, and he fell down.” “He was at home with his son when he felt weak and fell without LOC or head trauma.” “He has had significant tremor and weakness. He has had a fall.” “He fell today … He has become increasingly fatigued.” “When he was getting up from the toilet, [he] collapsed to the floor… He notes his muscles all felt very weak and could not hold up his weight.” “He was malaise-ridden and fatigued.” “Falls are happeing because his legs become weak as he steps out of his van.” “He has a recent history of falls which led to … the discovery of brain metastasis.” “[The patient reports] recent falls/functional decline.” “He was feeling weak … that was the reason for his fall.”
ORTHOSTATIC STYMPTOMS	“He became lightheaded and fell to the floor… at the ED he was orthostatic with lying BP 109/60, sitting 80/56, and standing 55/39.” “[The] fall was likely secondary to orthostatic hypotension.” “He was just standing in the tub and starting drying himself off and had a sudden loss of consciousness.” “[The patient had] four days of chemotherapy last week … and began to experience anorexia and dehydration. She had two episodes of blacking out.” “[The patient] prepped for colonoscopy then fell on two occasions, once in the bathroom getting out of the tub.” “On the day of admission, she had 2 episodes of syncope/presyncope when standing … [She] felt lightheaded and dizzy beforehand … [She] was also having diarrhea … [and] has not been able to take any oral fluids.” “Upon rising from the sitting to the standing position, a few seconds later … [he] felt like somebody had put a sheet over his eyes, felt very lightheaded, and fell to the floor… When he attempted to get out of bed, he felt very lightheaded and fell to the floor” “She had symptoms of orthostasis during his hospitalization, including one episode involving a fall.” “At one time [the patient] became dizzy and had a minor fall.” “This [fall] happened while he was trying to get out of a wheelchair; he felt dizzy and fell to the ground … He felt like he was going to lose consciousness, and then apparently fell.” “He was on his way to the restroom and was lightheaded and did fall.” “[The patient] was going to an appointment this morning, felt lightheaded, fell to his knees, then remembers waking up on the ground … He has had some diarrhea [and] a bit of nausea.” “When standing up and starting to move, he fell unexpectedly.” “He apparently was not feeling well, like he was going to pass out… [B]lood pressure was in the 60s systolic … [H]e did have a fall.” “[The patient] got up to go to the restroom and got dizzy and fell.” “It was felt that this fall was due to orthostatic hypotension.” “He does have lightheadedness when he gets up.” “Patient states that he got up from sitting and was walking over to the counter when he felt dizzy, lost his footing, and fell on his right hip.” “[The patient reports] blood racing to head, lightheadedness, and shaking in both upper and lower extremities associated with falls.” “It (review of systems) was found to be positive for dizziness for the last one week leading to fall.” “He had an episode of lightheadedness and fell on his back and right side.”
OTHER (includes unspecified causes, non-chemotherapy medications, and more typical causes, such as slipping on ice)	“[He] fell in his garage.” “He did, unfortunately, have a dislocation of his left shoulder after a fall about 8 weeks ago.” “[The patient] slipped … and fell.” “[The patient] had a fall while getting out of his truck.” “Unfortunately, 4-5 days after his chemotherapy, he fell down some stairs.” “A few days after his discharge from the hospital, he fell and then was hospitalized at home.” “He did have a fall several weeks ago on the ice and injured his left shoulder, and this has been slowly recovering.” “[The patient has a] tendency to fall easily.” “[The patient] fell in his bathtub at home and is having some back pain.” “[The patient] recently had a ground level fall.” “[H]e slipped when stepping off his porch at the house he is building and fell.” “[The patient] slipped and fell on ice … [The fall was] mechanical.” “[The patient] fell backwards on an escalator.” “Patient presents with 4 days of left hand/wrist pain after falling down a flight of stairs in her home.” “She fell on the steps … for no apparent reason.” “He reports falling yesterday in the bathroom, predominantly on his left-hand side.” “He also gave a history of having fallen directly onto his right shoulder while playing soccer.” “He did suffer a fall last November when he tripped on his cat.” “[She] was in the bathroom drying off from a shower when her feet slipped out from under her.” “[The patient] tells me that he fell several days ago getting out of a chair.” “He tripped over his shoelace and landed on the left side and hit a hard surface.” “He indicates that over the weekend he fell and ever since then has had vomiting and diarrhea.” “This evening, he took his Ambien for sleep, Ativan for anxiety and nausea and took a shower… His son [later] told him that he had fallen in the shower.” “[The patient is] somewhat sleepy … [He] discontinued Celexa as it made him feel groggy … [and] fell out of bed last night.” “He did have dizziness, nausea, and vomiting earlier in the day … His wife states that before the falls his arms and legs shake. This was occurring more frequently when he was receiving chemoradiation.” “[The patient sustained a] fall from a horse.” “[The patient] fell off bike.” “[He reports] falling off a ladder. He also hit the back of his head at the fall.”

DISCUSSION

To our knowledge, this is one of the few studies to describe fall rates in a group of age-unspecified patients with locally-advanced esophageal cancer and to describe the circumstances surrounding these falls. Rates of falls among cancer patients varies markedly in the published literature – anywhere from 20% to over 50% -- but most studies have focused on older patients [10–12]. Interestingly, although the current study included adults of all ages, we observed a fall rate similar to what has been previously reported, and we observed that some of these younger patients sustained an injurious fall. Moreover, the median age at first fall was under 65 years of age, and the median time to first fall was under one year – two observations that highlight that falls can occur in younger cancer patients and that, from a timing standpoint, these untoward events may be associated with cancer treatment. These observations suggest a need to continue to study falls in all cancer patients -- regardless of age -- with the goal of understanding risk factors and of learning ways to mitigate this risk for falling.

Another noteworthy finding of this study is that approximately one-third of patients had completed cancer therapy and remained cancer-free at the time of their fall. This observation speaks to the point that fall risk can be a cancer survivorship issue, as some falls occurred over 5 years after cancer diagnosis, and that clinicians should remain continuously vigilant for fall risk over time.

A unique aspect of the current study is its use of the medical record to probe into the circumstances surrounding each fall. Although some falls seemed to occur as a result of commonplace reasons, such as falling on ice or tripping over a cat, other reasons, such as orthostatic symptoms and neuropathic symptoms seemed to associate these untoward events with cancer treatment. Admittedly, one can never be sure of cause and effect within the context of the study design used here, but the results presented here might lead clinicians to caution patients who receive combined modality therapy for locally advanced esophageal cancer to be aware that they might be at risk for falls, to remain more vigilant in the assessment of dehydration, to exercise caution in prescribing drugs that sedate, and to consider referral of some patients with neuropathic symptoms to a physical therapist.

Importantly, the fall rate captured in the current study may underestimate the actual rate of falls. To capture a fall event with the medical record-based methodology used here, the patient must have reported the fall to his/her healthcare provider and that healthcare provider must have deemed the event important enough to record it. This methodology predisposes to underreporting for well-described reasons. First, patients with cancer are not forthcoming in reporting falls. Sattar and others reported that only 43% of cancer patients who had fallen reported their fall to their oncology healthcare provider [13]. Second, cancer clinicians are not documenting these events. Guerard and others comment that only 1 in 10 patient-reported falls are appropriately documented in the medical record [14]. Thus, between suboptimal reporting on the part of patients and suboptimal documentation on the part of cancer clinicians, it is very likely that the actual rate of falls among patients with locally advanced esophageal cancer exceeds that reported here.

In contrast to this tendency to underreport falls, our study might be over-reporting fall morbidity. Sattar and others observed that for cancer patients who are not hospitalized for a fall, fall morbidity, including the type and severity of injury, often goes unreported [15]. Although the current study found that well over half of patients who fell sustained major morbidity, such as fractures, bleeding complications, and musculoskeletal injury, the conclusions from Sattar and others suggest the possibility that non-injurious falls were occurring among the patients we studied but that these falls were not reported, did not result in injury, but resulted in an overinflation of the percentage of patients who suffered an injurious fall within the current report [15].

Finally, the treatment of patients with locally advanced esophageal cancer continues to change and improve. It is possible that, as newer state-of-the-art antineoplastic agents and radiation techniques become better tolerated and more widespread, the side effect profile of combined modality therapy for locally advanced esophageal cancer will also become more manageable and lead to lesser fall risk. Until then, however, it seems appropriate to continue to study risk factors for falls in this group of patients and to make use of practices, as appropriate, to reduce this risk. These practices include referral to physical therapy programs, the promotion of exercise, managing hypotension, and engagement of specialists with expertise in managing and treating vision and podiatric issues [16]. This study underscores the need to exercise awareness and caution as patients with locally advanced esophageal cancer undergo treatment and receive follow up.