American Ginseng in Treating Patients With Fatigue Caused by Cancer
Condition: 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
MeSH terms: Lymphoma; Leukemia; Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Plasmacytoma; Precancerous Conditions; Myelodysplastic Syndromes; Myeloproliferative Disorders; Lymphoproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome; Fatigue
Intervention: American ginseng; placebo
Intervention description: Given orally; Given orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 364.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        1. Required characteristics

               -  ≥ 18 years of age

               -  Men or women with a history of cancer-related fatigue as defined by an average
                  score ≥ 4 over the past 30 days on the numeric analogue scale (1 - 10)

               -  The presence of fatigue ≥ 1 month prior to randomization

               -  ECOG performance score 0, 1, or 2

               -  Histologic or cytologic proven cancer other than brain cancer or CNS lymphoma,
                  undergoing curative intent therapy (including anti-hormonal therapies such as
                  tamoxifen or leuprolide) or those having completed curative intent therapy who
                  were diagnosed within the past 2 years

                    -  Note: If a patient is receiving treatment for their disease such as
                       chemotherapy, targeted therapies, immunotherapy or radiation therapy then,
                       the patient must have completed ≥ 1 cycle of chemotherapy, targeted therapy,
                       or ≥ 1 week of radiation treatment.

               -  Laboratory values obtained prior to randomization:

                    -  Hgb ≥ 11 (must be obtained ≤ 30 days; patients must not be transfused ≤ 30
                       days to meet this criterion)

                    -  Creatinine ≤ 1.2 x UNL (must be obtained ≤ 180 days prior to randomization)

                    -  AST (SGOT) or ALT (SGPT) ≤ 1.5 x UNL (must be obtained ≤ 180 days prior to
                       randomization)

               -  Negative pregnancy test done ≤ 7 days prior to registration, for women of
                  childbearing potential only

               -  Ability to complete patient questionnaires alone or with assistance

               -  Controlled:

                    -  Pain (≤ 4 on Linear Analogue Scale)

                    -  Insomnia (≤ 4 on Linear Analogue Scale)

               -  Willingness to provide blood/saliva samples for correlative studies.

                    -  Note: These samples are only required for those not receiving active
                       treatment for their disease. Active treatment is defined as chemotherapy,
                       radiation therapy, or immunotherapy, not anti-hormone therapy such as
                       tamoxifen, aromatase inhibitors or leuprolide.

          2. Contraindications

               -  Hypersensitivity to ginseng

               -  Prior use of ginseng capsules for fatigue in the past year

                    -  Note: Prior use of teas or drinks containing ginseng is allowed, however,
                       patients will be asked to avoid these beverages while on the study.

               -  Uncontrolled hypertension on more than one occasion (diastolic blood pressure >
                  100, systolic > 160) measured ≤ 90 days prior to randomization

               -  Currently using any other pharmacologic agents or nonpharmacologic interventions
                  to specifically treat fatigue including psychostimulants, antidepressants,
                  acupuncture, etc.

                    -  Note: Antidepressants used to treat items other than fatigue (such as hot
                       flashes) are allowed if the patient has been on a stable dose for ≥ 1 month
                       and plans to continue for ≥ 1 month. Erythropoietin agents to treat anemia
                       are allowed. Exercise is allowed.

               -  Known brain metastasis or primary CNS malignancy

               -  Chronic systemic steroid use (including CHOP therapy or as part of any regular
                  cancer treatment, however, steroids used as prophylaxis for nausea and vomiting
                  are allowed) to prevent rash with Alimta, low dose dexamethasone will be allowed.

               -  Diabetes Type I or II (defined by being on oral hypoglycemics or insulin).

               -  Psychiatric disorder such as severe depression, manic depressive disorder,
                  obsessive compulsive disorder or schizophrenia. (Defined per medical history).

               -  ≤ 4 weeks from major surgery to randomization, including any procedure that
                  requires general anesthetic

               -  Any of the following:

                    -  Pregnant women

                    -  Nursing women

                    -  Women of childbearing potential who are unwilling to employ adequate
                       contraception

               -  Pain requiring opioid pain medication, however, over the counter analgesics such
                  as Tylenol or ibuprofen are allowed.

               -  Use of full dose of anticoagulant therapy (Exception: 1 mg/day of Coumadin for
                  preventing catheter clots is allowed).

               -  Use of MAO inhibitors.

               -  Planning to start or complete any type of cancer therapy during the 8 week,
                  double blind, course of the study, once randomized on the study. Note: If not
                  currently getting treatment, no chemotherapy agents ≤ 21 days prior to
                  randomization. Combination treatment regimens that have components ending at
                  different times are allowed, as long as any part of the initially started
                  treatment continues through the double blind portion of the study.

               -  Malnutrition, active infection, significant pulmonary disease and cardiovascular
                  disease as determined by the physician, as they could impact fatigue.

               -  Use of any over the counter herbal/dietary supplement marketed for fatigue or
                  energy (for example, products containing any type of ginseng, rhodiola rosea,
                  high doses of caffeine, guarana, or anything called an "adaptogen").

               -  Uncontrolled nausea or vomiting or any symptom that would prevent the ability to
                  comply with daily oral ginseng/placebo treatment.

               -  Uncontrolled thyroid disorder.

               -  Currently receiving single agent on blinded placebo controlled treatment trials.