Assessment of patient-reported measures of bowel function before and after pelvic radiotherapy: an ancillary study of the North Central Cancer Treatment Group study N00CA.

PURPOSE: The Bowel Function Questionnaire (BFQ) has been used in clinical trials to assess symptoms during and after pelvic radiotherapy (RT). This study evaluated the importance of symptoms in the BFQ from a patient perspective. METHODS: Patients reported presence or absence of symptoms and rated importance of symptoms at baseline, 4 weeks after completion of pelvic RT, and 12 and 24 months after RT. The BFQ measured overall quality of life (QOL) and symptoms of nocturnal bowel movements, incontinence, clustering, need for protective clothing, inability to differentiate stool from gas, liquid bowel movements, urgency, cramping, and bleeding. Bowel movement frequency also was recorded. A content validity questionnaire (CVQ) was used to rate symptoms as "not very important," "moderately unimportant," "neutral," "moderately important," or "very important." RESULTS: Most of the 125 participating patients rated all symptoms as moderately or very important. Generally, patients gave similar ratings for symptom importance at all study points, and ratings were independent of whether the patient experienced the symptom. Measures of greatest importance (moderately or very important) at baseline were ability to control bowel movements (94 %), not having to wear protective clothing (90 %), and not having rectal bleeding (94 %). With the exception of need for protective clothing, the presence of a symptom at 4 weeks was associated with significantly worse QOL (P < .01 for all). CONCLUSIONS: The BFQ has excellent content validity. Patients rated most symptoms as moderately or very important, indicating the BFQ is an appropriate tool for symptom assessment during and after pelvic RT.

Outcomes after percutaneous surgery for patients with multiple sclerosis-related trigeminal neuralgia.

BACKGROUND: Approximately 1% to 2% of patients with multiple sclerosis (MS) develop trigeminal neuralgia (TN). Percutaneous surgery is commonly performed in medically refractory cases. OBJECTIVE: To analyze the pain outcomes and complications of patients with MS-related trigeminal neuralgia (MS-TN) having percutaneous surgery. METHODS: Patients having balloon microcompression (BMC; n = 69) or glycerol rhizotomy (PRGR; n = 67) from 1997 to 2010 were reviewed retrospectively. Patients in the 2 groups were similar with regard to age, sex, pain location, and pain quality. Mean pain duration was longer in the PRGR group (54.6 vs 16 months; P < .001); more patients having BMC had prior surgery (87% vs. 48%; P < .001). Outcomes were defined as excellent (no pain, no medications), good (no pain with medications), and poor. Median follow-up was 13 months (range, 0.25-132 months). RESULTS: Ninety-five patients initially had excellent (n = 45, 33%) or good (n = 50, 37%) outcomes. Pain relief was maintained in 58% of patients at 3 months and 28% at 2 years. There was no difference in excellent/good outcomes between the surgical groups (hazard ratio = 0.73; P = .14). No correlation was noted between pain relief and new or increased facial numbness (hazard ratio = 0.78; P = .19). Forty-four BMC patients (64%) had additional surgery compared with 36 PRGR patients (54%; P = .19). Complications were more frequent after BMC (17.4% vs 3.0%; P < .01). CONCLUSION: Percutaneous surgery for patients with MS-TN is less likely to provide pain relief than similar operations performed for patients with idiopathic TN. New trigeminal deficits did not correlate with better facial pain outcomes, supporting the concept that many patients with MS-TN have centrally mediated pain.

Posterior fossa exploration for trigeminal neuralgia patients older than 70 years of age.

BACKGROUND: Patients with medically unresponsive trigeminal neuralgia (TN) who are >70 years of age often undergo operations that typically provide pain relief for <5 years despite having a life expectancy that can exceed 15 years. OBJECTIVE: To review the safety and efficacy of posterior fossa exploration (PFE) for TN patients > 70 years of age. METHODS: From 1999 to 2009, 67 TN patients >70 years of age (median, 74 years) underwent a PFE. Thirty-seven patients (55%) had failed ≥ 1 prior surgeries (median, 2). Fifty-nine patients (88%) had a microvascular decompression, and 8 patients (12%) underwent a partial sensory rhizotomy. Follow-up (median, 40 months) was censored at the time of last contact (n = 51), additional surgery (n = 12), or death (n = 4). RESULTS: Complete pain relief (no pain, no medications) was 87% at 1 year and 78% at 5 years. Facial pain outcomes did not correlate with patient age, sex, prior surgery, or pain duration. Postoperative complications were noted in 10 patients (15%) and included ataxia (10%), hearing loss (5%), trigeminal dysesthesias (5%), facial weakness (3%), aseptic meningitis (2%), and pulmonary embolus (2%). Factors associated with postoperative complications were prior PFE (P = .01) and neurovascular compression from a dolicoectatic basilar artery (P = .03). CONCLUSION: Posterior fossa exploration is safe and effective for physiologically healthy TN patients >70 years of age. It should be deferred in older patients with TN secondary to a dolicoectatic basilar artery and patients who have persistent/recurrent pain after a previous PFE unless simpler procedures prove ineffective at controlling their facial pain.

Phase III, double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea in patients receiving pelvic radiation therapy: results of North Central Cancer Treatment Group N00CA.

PURPOSE: To assess the effectiveness of depot octreotide for the prevention of diarrhea during pelvic radiation therapy. PATIENTS AND METHODS: Patients receiving pelvic radiation therapy (planned minimum dose, 45 Gy; 1.7 to 2.1 Gy daily) were eligible for the study. From May 10, 2002, through October 14, 2005, 125 patients were randomly allocated in a double-blind fashion to receive octreotide (100 microg, administered subcutaneously on day 1, followed by depot octreotide, 20 mg, administered intramuscularly on days 2 and 29; n = 62) or to receive a placebo (n = 63). RESULTS: Grade 0, 1, 2, and 3 diarrhea were observed in 18%, 31%, 31%, and 21% of patients in the octreotide arm, respectively, and in 25%, 32%, 22%, and 21% of patients in the placebo arm, respectively (P = .64). Grade 0, 1, 2, and 3 abdominal cramps were observed in 32%, 45%, 21%, and 2% of patients receiving octreotide, respectively, and in 51%, 24%, 21%, and 5% of patients receiving the placebo, respectively (P = .053). Some patient-reported symptoms were worse in the octreotide group, including nocturnal bowel movements (70% v 45%; P = .004), clustering of bowel movements (90% v 69%; P = .004), and bleeding with bowel movements (57% v 35%; P = .01). CONCLUSION: As administered in this study, octreotide did not decrease diarrhea during pelvic radiation therapy. Some gastrointestinal symptoms were worse in patients treated with octreotide. Octreotide is not indicated for prevention of diarrhea during pelvic radiation therapy.