Clinical trial NCT00719563
Conditions: Chronic Myeloproliferative Disorders Fatigue Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific
Keywords: fatigue unspecified adult solid tumor, protocol specific accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) atypical chronic myeloid leukemia, BCR-ABL1 negative blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia mast cell leukemia progressive hairy cell leukemia, initial treatment prolymphocytic leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult T-cell leukemia/lymphoma refractory chronic lymphocytic leukemia refractory hairy cell leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia stage 0 chronic lymphocytic leukemia stage I adult T-cell leukemia/lymphoma stage I chronic lymphocytic leukemia stage II adult T-cell leukemia/lymphoma stage II chronic lymphocytic leukemia stage III adult T-cell leukemia/lymphoma stage III chronic lymphocytic leukemia stage IV adult T-cell leukemia/lymphoma stage IV chronic lymphocytic leukemia T-cell large granular lymphocyte leukemia untreated adult acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma cutaneous B-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome adult grade III lymphomatoid granulomatosis adult nasal type extranodal NK/T-cell lymphoma Waldenström macroglobulinemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma contiguous stage II adult Burkitt lymphoma contiguous stage II adult diffuse large cell lymphoma contiguous stage II adult diffuse mixed cell lymphoma contiguous stage II adult diffuse small cleaved cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult lymphoblastic lymphoma contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II grade 3 follicular lymphoma contiguous stage II mantle cell lymphoma contiguous stage II marginal zone lymphoma contiguous stage II small lymphocytic lymphoma stage I adult Burkitt lymphoma stage I adult diffuse large cell lymphoma stage I adult diffuse mixed cell lymphoma stage I adult diffuse small cleaved cell lymphoma stage I adult immunoblastic large cell lymphoma stage I adult lymphoblastic lymphoma stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage I grade 3 follicular lymphoma stage I mantle cell lymphoma stage I marginal zone lymphoma stage I small lymphocytic lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma noncontiguous stage II marginal zone lymphoma noncontiguous stage II small lymphocytic lymphoma stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III mantle cell lymphoma stage III marginal zone lymphoma stage III small lymphocytic lymphoma stage IV adult Burkitt lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma stage IV marginal zone lymphoma stage IV small lymphocytic lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult grade III lymphomatoid granulomatosis recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma intraocular lymphoma post-transplant lymphoproliferative disorder chronic eosinophilic leukemia chronic neutrophilic leukemia primary myelofibrosis essential thrombocythemia polycythemia vera extramedullary plasmacytoma isolated plasmacytoma of bone monoclonal gammopathy of undetermined significance stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma primary systemic amyloidosis refractory multiple myeloma de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes myelodysplastic/myeloproliferative neoplasm, unclassifiable
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2008-10-01; Completion date: 2013-08-01
Enrollment: 364 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: American ginseng may reduce fatigue in patients with cancer. It is not yet known whether American ginseng is more effective than a placebo in treating cancer-related fatigue.

PURPOSE: This randomized phase III trial is studying American ginseng to see how well it works in treating patients with fatigue caused by cancer.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the efficacy of American ginseng (Panax quinquefolius) as therapy for cancer-related fatigue as measured by the general subscale of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF).

Secondary

* To evaluate toxicities and tolerability of American ginseng when used for cancer-related fatigue.
* To examine stress as a mediating variable on the effects of American ginseng on cancer-related fatigue.
* To explore the impact of American ginseng on various dimensions of fatigue as measured by the other subscales of the MFSI-SF, functional interference as measured by the Brief Fatigue Inventory (BFI), stress as measured by the Perceived Stress Scale, and well being as measured by the Profile of Mood States (POMS), as well as the single measure of fatigue.
* To determine clinically significant changes in fatigue scores using the global impression of change.
* To evaluate whether there are differences in the efficacy of American ginseng for fatigue based on minority populations.

Tertiary

* To describe cortisol and cytokine values in fatigued cancer survivors and to evaluate the relationship of cortisol and cytokines to fatigue severity as well as to patterns of alterations previously documented in fatigued breast cancer survivors.
* To evaluate whether Wisconsin Ginseng impacts the expression of cortisol and cytokine in fatigued cancer survivors.
* To evaluate the role of cortisol and cytokine changes as the mechanism by which Wisconsin Ginseng can ameliorate cancer related fatigue.
* To evaluate the relationships between cytokine and cortisol levels with secondary outcomes such as mood and stress.

OUTLINE: This is a multicenter study. Patients are stratified according to baseline fatigue score (4-7 vs 8-10), disease status of current cancer (initial diagnosis vs recurrent disease), current treatment (chemotherapy, radiation, endocrine therapy \[i.e., tamoxifen or aromatase inhibitors\], or other targeted therapy) ( yes vs no), duration of all prior cancer treatment in patient's lifetime (none vs ≤ 180 days vs \> 180 days), and current tumor type (hematologic vs solid tumor malignancy). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral American ginseng twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses until disease progression or unacceptable toxicity.
* Arm II: Patients receive oral placebo twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.

Patients are instructed to complete the Ginseng Symptom Experience Diary and the Linear Analogue Scale weekly. Patients also complete the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Profile of Mood States (POMS), and the Brief Fatigue Inventory (BFI) questionnaires at baseline and periodically during study therapy.

Patients who are not actively receiving chemotherapy or radiation therapy undergo blood and saliva sample collection at baseline and periodically during study therapy for correlative studies.

Arms: arm 1: Patients receive oral American ginseng twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses. arm 2: Patients receive oral placebo twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.
Interventions: intervention 1: American ginseng intervention 2: placebo
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents: