J. Granick

Phase I/II trial of the safety and efficacy of shark cartilage in the treatment of advanced cancer

PURPOSE Patients with cancer and chronic inflammatory disorders have used shark cartilage (SC) preparations for many years. Preclinical studies that support their beneficial effects are scanty, and reports of clinical trials have been anecdotal. The proposed mechanisms of antitumor action include direct or indirect inhibition of angiogenesis. Because of the emerging use of SC as an alternative to conventional cancer therapy, this trial was launched to evaluate the safety and efficacy of SC. PATIENTS AND METHODS Sixty adult patients with advanced previously treated cancer (breast, 16 patients; colorectal, 16 patients; lung, 14 patients; prostate, eight patients; non-Hodgkin lymphoma, three patients; brain, one patient; and unknown primary tumor, two patients) were enrolled. Eligibility criteria included confirmation of diagnosis, resistance to conventional therapy, objective measurable disease, life expectancy of 12 weeks or greater, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, no recent or concomitant anticancer therapy, no prior SC, and informed consent. Patients underwent evaluation of the extent of disease, quality-of-life score (Functional Assessment of Cancer Therapy-General [FACT-G] scale), and hematologic, biochemical, and selected immune function studies at baseline and after 6 and 12 weeks of SC therapy. The dose of SC was 1 g/kg daily orally in three divided doses. Standard criteria were used to evaluate adverse events and response. RESULTS Ten of 60 patients were lost to follow-up(LTFU) or refused further treatment (RFT) before the 6-week evaluation and were not assessable for toxicity and response. Three patients with stable disease at 6 weeks were LTFU or RFT thereafter. Of the 47 fully assessable patients, five were taken off study because of gastrointestinal toxicity or intolerance to SC. Progressive disease (PD) at 6 or 12 weeks occurred in 22 and five patients, respectively. Five patients died of PD while undergoing SC therapy. No complete (CRs) or partial responses (PRs) were noted. Median time to tumor progression in the entire study population was 7+/-9.7 weeks (mean, 11.4 weeks; range, 3.7 to 45.7 weeks). Ten (20%) of 50 assessable patients, or 16.7% of the 60 intent-to-treat patients, had stable disease (SD) for 12 weeks or more. The median time to tumor progression was 27 weeks, the mean was 28.8+/-9.9 weeks, and the range was 18.6 to 45.7 weeks. In this subset, FACT-G scores improved in four patients, were unchanged in four patients, and declined in two patients. Twenty-one adverse events (grade 1, eight events; grade 2, seven events; and grade 3, six events) were recorded, 14 of which were gastroenterologic (nausea, vomiting, constipation). CONCLUSION Under the specific conditions of this study, SC as a single agent was inactive in patients with advanced-stage cancer and had no salutary effect on quality of life. The 16.7% rate of SD was similar to results in patients with advanced cancer treated with supportive care alone.

Self-reported quality of life in users and nonusers of dietary supplements in cancer

Goals of workTo describe the Quality of Life (QoL) characteristics of users of dietary supplements vs nonusers.Patients and methodsA survey of 225 cancer patients presenting for treatment at Cancer Treatment Centers of America was completed between November 2001 and October 2003. A validated instrument assessed the use of 56 dietary supplements in the past month. Two validated questionnaires assessed QoL. Mean QoL scores were compared between the users and nonusers using univariate and multivariate linear regression.ResultsOf 225 patients, 91 (40%) were males and 134 (60%) females. Sixty seven (30%) had breast cancer, 40 (18%) colorectal cancer, and 32 (14%) lung cancer. One hundred sixty four (73%) had used dietary supplements in the past month, while 61 (27%) had not. Mean European Organization for Research Treatment of Cancer QoL scores were significantly better among the users for physical and emotional function scales and fatigue, nausea, appetite loss, and constipation symptom scales adjusting for tumor site. In the stratified analysis, lung cancer patients did not show any statistically significant differences in QoL scores between the users and nonusers. Colorectal cancer patients demonstrated statistically significant differences in constipation symptom, with dietary supplement users having better QoL. Breast cancer patients demonstrated statistically significant differences in several QoL scale scores between users and nonusers.ConclusionsContrary to some of the previously published research, this study, conducted at a community hospital comprehensive cancer center that combines alternative treatment approaches with conventional cancer care, found better self-reported QoL among the users of dietary supplements, as compared to nonusers. The next step in this research is to prospectively evaluate the patterns of changing QoL in relation to dietary supplement use across the entire duration of cancer diagnosis and treatment.

Self -Reported Quality of Life in users and non-users of dietary supplements in cancer

8232 Background: Hospital-based surveys suggest that cancer patients routinely use dietary supplements, which include vitamins, minerals, and herbs. We described the QoL characteristics of users of dietary supplements versus non-users. Methods: A survey of 225 adult cancer patients presenting for treatment at Cancer Treatment Centers of America at Midwestern Regional Medical Center was completed between 11/01 and 10/03. A validated instrument (McCune Questionnaire) assessed the use of 56 dietary supplements in the past month. QoL was evaluated using the EORTC QLQ-C30 questionnaire. The mean QoL scores were compared between the dietary supplement users and non-users using linear regression models controlling for tumor site. Results: Of 225 patients, 91 (40%) were males and 134 (60%) females. 136 (57%) patients had failed prior treatment while 65 (29%) were newly diagnosed. 67 (30%) had breast cancer, 40 (18%) colorectal cancer, and 32 (14%) lung cancer. 164 (73%) had used dietary supplements in the past mo...

Quality of life outcomes of advanced colorectal cancer in an integrative treatment setting: The Cancer Treatment Centers of America experience

3694 Background: Cancer patients undergoing aggressive chemotherapy can sometimes experience an initial deterioration in quality of life (QoL). In this study we investigated the QoL outcomes of advanced colorectal cancer patients during the first three months of chemotherapy. METHODS We evaluated a case series of 31 stages III-IV colorectal cancer patients treated at Cancer Treatment Centers of America at Midwestern Regional Medical Center between March 2001 and January 2003. All patients underwent a comprehensive program of nutritional, spiritual, physical, naturopathic, and emotional support while receiving aggressive chemotherapy. QoL was evaluated using the EORTC-QLQ-C30 (EORTC) and the Ferrans and Powers Quality of Life Index (QLI). The mean QoL scores were compared using Analysis of Variance across three different time periods; baseline, 1 and 3 months. RESULTS Patients received a variety of chemotherapy regimens; 12 (38.7%) received leucovorin (lv)-floxuridine (dr)-mitomycin-cisplatin; 6 (19.4%) lv-dr-mitomycin; 5 (16.1%) lv-5 fluorouracil; 4 (12.9%) lv-dr; 3 (9.7%) lv-dr-camptosar and 1 (3.2%) oxaliplatin. Mean QoL scores in both EORTC and QLI showed no significant difference across the three time periods. CONCLUSIONS In this cohort, we found that QoL was well-maintained throughout the first three months of chemotherapy in our integrative cancer treatment setting. These results warrant further investigation to better describe the impact of integrative care on the QoL of these patients. [Figure: see text] No significant financial relationships to disclose.