American Ginseng in Treating Patients With Cancer-Related Fatigue
キーワード
概要
説明
OBJECTIVES:
Primary
- Compare the efficacy of American ginseng, administered at 3 different doses, vs placebo in patients with cancer-related fatigue.
Secondary
- Determine the toxic effects and tolerability of American ginseng in these patients.
- Determine the impact of American ginseng on quality of life-related variables (e.g., sleep, vitality, and quality of life domains) in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (I or II vs III or IV vs unknown), gender (male vs female), baseline fatigue score (4-7 vs 8-10), concurrent chemotherapy (yes vs no), and concurrent radiotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
日付
| 最終確認済み: | 09/30/2017 |
| 最初に提出された: | 09/14/2005 |
| 提出された推定登録数: | 09/14/2005 |
| 最初の投稿: | 09/15/2005 |
| 最終更新が送信されました: | 10/26/2017 |
| 最終更新日: | 10/30/2017 |
| 実際の研究開始日: | 09/30/2005 |
| 一次完了予定日: | 09/04/2006 |
| 研究完了予定日: | 03/31/2010 |
状態または病気
介入/治療
Dietary Supplement: American ginseng
Other: Arm IV - Placebo
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Arm I - American ginseng (low dose) Patients receive oral American ginseng twice daily for 8 weeks in the absence of unacceptable toxicity.
After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study.
Quality of life is assessed at baseline, every 2 weeks during treatment, and at the end of treatment.
PROJECTED ACCRUAL: A total of 280 patients (70 per treatment arm) will be accrued for this study within 35 months. | |
| Experimental: Arm II - American ginseng (mid-dose) Patients receive oral American ginseng at the mid-dose twice daily for 8 weeks in the absence of unacceptable toxicity.
After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. | |
| Experimental: Arm III - American ginseng (high-dose) Patients receive oral American ginseng at the high dose twice daily for 8 weeks in the absence of unacceptable toxicity.
After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. | |
| Other: Arm IV - Placebo Patients receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. | Other: Arm IV - Placebo |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed cancer - Experiences cancer-related fatigue, defined as a baseline fatigue score of ≥ 4 on a numerical analogue scale (0-10) - Fatigue must be present for ≥ 1 month before study entry - No primary brain cancer, brain metastases, or other CNS malignancy, including CNS lymphoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 6 months Hematopoietic - Hemoglobin ≥ 11 g/dL Hepatic - SGOT ≤ 1.5 times upper limit of normal (ULN) Renal - Calcium ≤ 1.2 times ULN - Creatinine ≤ 1.2 times ULN Cardiovascular - No uncontrolled hypertension (i.e., diastolic blood pressure [BP] > 100 mm Hg and/or systolic BP > 160) Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No diabetes, defined as receiving oral hypoglycemics or insulin - No hypersensitivity to ginseng - No uncontrolled pain, hypothyroidism, or insomnia that is considered to be the primary cause of patient's fatigue - Not currently under the care of a psychiatrist for documented psychiatric disorder (e.g., severe depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia) PRIOR CONCURRENT THERAPY: Biologic therapy - Concurrent epoetin alfa for treatment of anemia allowed Chemotherapy - Concurrent chemotherapy allowed except CHOP therapy Endocrine therapy - No concurrent chronic systemic steroids Radiotherapy - Not specified Surgery - More than 4 weeks since prior major surgery Other - No prior ginseng capsules for fatigue - Prior ginseng-containing teas or drinks purchased at a grocery store allowed - No concurrent pharmacologic agents for the treatment of fatigue, including any of the following: - Psychostimulants - Antidepressants - Antidepressants used to treat conditions other than fatigue (e.g., hot flashes) are allowed provided the patient has been on a stable dose for ≥ 1 month and plans to continue antidepressant for ≥ 1 month - No concurrent monoamine oxidase inhibitors - No concurrent full anticoagulation doses of warfarin or heparin - A dose of 1 mg/day for preventing catheter clots allowed |
結果
主な結果の測定
1. Fatigue by brief inventory at 4 and 8 weeks of treatment [at 4 and 8 weeks]
二次的な結果の測定
1. Sleep by Pittsburg Sleep Quality Inventory at 4 and 8 weeks of treatment [at 4 and 8 weeks]
2. Quality of life by North Central Cancer Treatment Group Uniscale at 4 and 8 weeks of treatment [at 4 and 8 weeks]
