Health TrialsbyHealthPanel

Wisconsin Ginseng for Decreasing Cancer Related Fatigue

ConditionMalignant Solid Neoplasm
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

This phase III trial compares the effect of Wisconsin ginseng (panax quinquefolius) to placebo in patients with cancer that suffer from significant fatigue. Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. American ginseng (Western ginseng) appears to be a promising appearing agent for treating cancer related fatigue. Western ginseng may reduce cancer-related fatigue.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Has received or is receiving treatment for a solid-organ malignancy (not hematologic)

History of cancer-related fatigue as defined by an average score ≥ 4 over the past 30 days on the numeric analogue scale. Patients can answer questions orally rather than completing worksheet

Baseline control of insomnia: Insomnia ≤ 4 on Linear Analogue Scale. Patients can answer questions orally rather than completing worksheet

Disqualifiers

Any known hypersensitivity to ginseng

Currently using any other pharmacologic agents to specifically treat fatigue including psychostimulants or antidepressants. Note: Antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for ≥ 30 days and plan to continue such for 8 weeks. Exercise is allowed

Psychiatric disorder such as poorly controlled depression, manic depressive disorder, obsessive compulsive disorder, or schizophrenia (defined per medical history)

Use of erythropoietic agents ≤ 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • American Ginseng

    Dietary supplement

    Given PO

  • Placebo Administration

    Drug

    Given PO

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Group I (Western ginseng)Experimental treatment 2 interventions
Group B: Group II (placebo)Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in fatigue

Will be measured by the Linear Analog Scale for Fatigue, a single-item questionnaire rating fatigue over the pats week on a scale of 0-10 where 0=no fatigue at all and 10=fatigue as bad as it can be.

Time frame
Baseline to 8 weeks

Secondary outcomes

1

Change in fatigue

Will be measured by the Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-Fatigue) Scale, which consists of 13 questions answered on a scale of 0-4 where 0=not at all and 4=very much.

Time frame
Baseline, 4 and 8 weeks
2

Percentage of patients who perceive moderate to very much better fatigue

Will be measured by the Global Impression of Change, which consists of 3 questions answered on a scale of -3 (very much worse) to 3 (very much better), one question as to whether the participants thought they were receiving the intervention (ginseng) or placebo, and one question related to satisfaction with the effect of the treatment on their fatigue (yes/no).

Time frame
At 8 weeks
3

Incidence of adverse events

Will be measured by the Common Terminology Criteria for Adverse Events (CTCAE) and/or the Ginseng Symptom Experience Diary and compared between arms.

Time frame
Up to 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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