Symptom & Toxicity Management
With the help of the CCOPs, MB-CCOPs and Research Bases, more clinical trials than ever before are incorporating patient-reported outcomes to better capture the clinical benefit and risks of cancer therapies. CCOP network studies include symptom management, toxicity reduction, supportive and palliative care, and quality of life.
Symptom management trials to evaluate strategies for cancer indications or for toxicities resulting from treatment are the largest growth area for the CCOP network, with 21 new protocols approved in 2009. The toxicities of cancer treatment have changed over the past three decades due to the number of agents that target different mechanisms of action. Thus, nausea and vomiting were foremost issues 20 years ago, while others such as peripheral neuropathy, hypertension, and skin effects are emerging now as toxicities that limit the amount of cancer treatment a patient receives.
The CCOP program supports health-related quality-of-life research in cancer treatment, prevention, and control trials. A shift in focus over the past 20 years from global health-related quality of life to specific symptomatic toxicities expected to occur among patients was revealed in a recent review of breast, prostate, colorectal, and lung cancer treatment trials.
Published data from CCOP trials have demonstrated that the Common Terminology Criteria for Adverse Events (CTCAE) is an imprecise tool for reporting toxicities such as fatigue, pain, and subjective side effects. Consequently, NCI is developing an electronic-based system for patient reporting of symptomatic adverse events in conjunction with clinician reporting. The CCOP network is actively testing the incorporation of this Patient-Reported Outcome version of CTCAE to improve the accuracy of reporting of symptomatic side effects.
The range of issues in symptom and toxicity management for which CCOP Research Bases have designed and conducted trials includes evaluating agents to increase smoking cessation; varying approaches to facilitate understanding of informed consent and patient communication; markers for early detection of colorectal cancer; and methods for exploring how to evaluate exercise for symptom reduction and improved quality of life.
Selected Publications
- Barton DL, Wender DB, Sloan JA, et al. Randomized controlled trial to evaluate transdermal testosterone in female cancer survivors with decreased libido; North Central Cancer Treatment Group protocol N02C3. J Natl Cancer Inst. 2007 May 2;99(9):672-9.
[ PubMed Abstract ] - Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010 Mar 11;362(10):865-9.
[ PubMed Abstract ] - Clauser SB, Ganz P, Lipscomb J, Reeve BB. Patient-reported outcomes assessment in cancer trials: Evaluating and enhancing the payoff to decision making. J Clin Oncol. 2007 Nov 10;25(32):5049-50.
[ PubMed Abstract ] - Hartsell W, Scott C, Bruner D, et al. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases, 2005 J Natl Cancer Inst. 2005 Jun 1;97(11)798-804.
[ PubMed Abstract ] - Loprinzi CL, Barton DL, Sloan JA, et al. Mayo Clinic and North Central Cancer Treatment Group hot flash studies: a 20-year experience. Menopause. 2008 Jul-Aug;15(4 Pt 1):655-60.
[ PubMed Abstract ] - Loprinzi CL, Ellison NM, Schaid DJ, et al. A controlled trial of megestrol acetate in patients with cancer anorexia and/or cachexia. J Natl Cancer Inst. 1990 Jul 4;82(13):1127-32.
[ PubMed Abstract ] - Loprinzi CL, Qin R, Balcueva EP, et al. Phase III, randomized, double-blind, placebo-controlled evaluation of pregabalin for alleviating hot flashes, N07C1. J Clin Oncol. 2010 Feb 1;28(4):641-7. Epub 2009 Nov 9. Erratum in: J Clin Oncol. 2010 Apr 1;28(10):1808. Baclueva, Ernie P [corrected to Balcueva, Ernie P].
[ PubMed Abstract ] - Loprinzi CL, Kugler JW, Sloan JA, et al. Randomized comparison of megestrol acetate versus dexamethasone versus fluoxymesterone for the treatment of cancer anorexia/cachexia. J Clin Oncol. 1999 Oct;17(10):3299-306.
[ PubMed Abstract ] - Loprinzi CL, Kugler JW, Sloan JA, et al. Venlafaxine in management of hot flashes in survivors of breast cancer: a randomised controlled trial. Lancet. 2000 Dec 16;356(9247):2059-63.
[ PubMed Abstract ] - Loprinzi CL, Michalak JC, Schaid DJ, et al. Phase III evaluation of four doses of megestrol acetate as therapy for patients with cancer anorexia and/or cachexia. J Clin Oncol. 1994 Oct;51 Suppl 2-7.
[ PubMed Abstract ] - Minasian LM, O'Mara A, Reeve BB, et al. Health-related quality of life and symptom management research sponsored by the National Cancer Institute. J Clin Oncol. 2007 Nov 10;25(32):5128-23. Review.
[ PubMed Abstract ] - O'Mara AM, Denicoff AM. Health-related quality of life in NCI-sponsored cancer treatment trials. Semin Oncol Nurs. 2010 Feb; 26 (1):68-78.
[ PubMed Abstract ] - Roscoe JA, Bushunow P, Jean-Pierre P, et al. Acupressure bands are effective in reducing radiation therapy-related nausea. J Pain Symptom Manage. 2009 Sep;38(3):381-9. Epub 2009 Mar 28.
[ PubMed Abstract ] - Scarantino C, LeVeque F, Swann RS, et al. Effect of pilocarpine during radiation therapy: results of RTOG 97-09, a phase III randomized study in head and neck cancer patients. J Support Oncol. 2006 May;4(5):252-8.
[ PubMed Abstract ] - Trotti A, Colevas AD, Setser A, Basch E. Patient-reported outcomes and the evolution of adverse event reporting in oncology. J Clin Oncol. 2007 Nov 10;25(32):5121-7. Review.
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