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Ginseng

Regorafenib will be administered 160 mg once daily for the first 21 days of each 28-day cycle. Subjects will receive 1,000 mg ginseng orally twice daily every day for 4 weeks (2 cycles).

Regorafenib will be administered 160 mg once daily for the first 21 days of each 28-day cycle for 2 cycles.

All subjects will receive regorafenib 160 mg orally once daily for the first 21 days of each 28-day cycle for 2 cycles.

Regorafenib

Subjects randomized to ginseng will receive 1,000 mg orally twice every day of each 28-day cycle for 2 cycles.

Rodwige J. Desnoyers, M.D.

This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients treated with regorafenib to determine if ginseng will reduce fatigue in this patient population and improve adherence to regorafenib. Ninety (90) subjects will be enrolled and randomized using a 2:1 allocation, with 60 subjects enrolled in the regorafenib + ginseng group and 30 enrolled in the regorafenib + no ginseng group.

OUTLINE: This is a multi-center study.

INVESTIGATIONAL TREATMENT:

Regorafenib will be administered 160 mg orally once daily for the first 21 days of each 28-day cycle. Subjects that randomize to receive ginseng will take 1,000 mg orally twice daily every day for 4 weeks (2 cycles). Subjects that randomize to NOT receive ginseng will not be given ginseng. Subjects will be instructed to take regorafenib with a low-fat meal.

Subjects will undergo fatigue assessments, using the MFSI-SF instrument and PROMIS. Subjects will have a pill count C2D1 and at the end of treatment visit. Subjects will have the re-staging scan (CT of chest/abdomen/pelvis) at the end of Cycle 2/ week 8 (±5).

Adequate bone marrow, liver and renal function assessed by the following laboratory values obtained within 7 days prior to registration for protocol therapy:

Hematopoietic:

* Absolute neutrophil count (ANC) count \> 1,500/mm\^3
* Hemoglobin (Hgb) \> 9g/dL
* Platelet count \> 100,000/mm\^3

Renal:

* Serum creatinine ≤ 1.5 × the upper limit of normal (ULN)

Hepatic:

* Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).
* Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 × ULN for subjects with liver involvement of their cancer)
* Alkaline phosphatase (ALP) limit ≤ 2.5 × ULN (≤ 5 × ULN for subjects with liver involvement of their cancer)

Coagulation:

* International normalized ratio (INR)/Partial thromboplastin time (PTT) ≤ 1.5 × ULN. NOTE: Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable, based on a measurement that is pre-dose as defined by the local standard of care. Warfarin does should not exceed 1 mg.

Efficacy of Ginseng for Patients on Regorafenib

A Randomized Phase II Trial to Evaluate the Efficacy of Supportive Therapy With Ginseng for Patients on Treatment With Regorafenib

Fatigue will be assessed for subjects on each arm using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) and Patient-Reported Outcomes Measurement Information System (PROMIS)

Pill counts will be used to assess adherence to regorafenib for subjects on each arm

Toxicity assessed using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0) criteria

Retention will be determined by the proportion of subjects on each arm who complete the study.

the proportion of all subject with confirmed PR or CR according to RECIST v.1.1, from the start of treatment until disease progression/recurrence

date of randomization to date of death from any cause

Bayer

Hoosier Cancer Research Network

Rodwige J. Desnoyers

Sponsor-Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

American Ginseng, cpr 700 mg (500 mg of Panax Quinquefolius 5%): 1 cpr twice a day orally for 3 months

Placebo: 1 cpr twice a day orally for 3 months

American Ginseng

Placebo

Fausto Roila, Dr

Sonia Fatigoni, Dr

Among the symptoms referred by cancer patients, cancer related fatigue (CRF) is one of the most disabling symptom with a relevant impact on the quality of life.

CRF can occur before, during and after anti-cancer treatment. The aim of the present study is to verify the efficacy of American Ginseng in preventing or reducing the intensity of moderate-severe CRF in breast cancer women receiving adjuvant chemotherapy with anthracyclines plus cyclophosphamide after surgery.

Cancer related fatigue (CRF) can occur before, during and after anti-cancer treatment. In fact, up to 40% of patients report fatigue at diagnosis, 80%-90% during chemotherapy and radiotherapy, respectively and 20%-50% in the post-treatment phase.

All cancer patients should be screened for the presence of CRF at the first oncological visit and subsequently during and after the anticancer therapies.

If the patient refers CRF, it could be quantified with one of the validate instruments available; the possible determinants could be identified and corrected if possible, to reduce their impact on patients CR.

The most evaluated pharmacological treatments of CRF include psychostimulants (methylphenidate, modafinil, armodafinil) and dexamethasone. Non-pharmacological treatments include physical exercise, psychological therapies and complementary therapies such as agopuncture, yoga, ginseng.

The aim of the present study is to verify the efficacy of American Ginseng in preventing or reducing the intensity of moderate-severe CRF in a homogeneous population of breast cancer women submitted to adjuvant chemotherapy with anthracyclines plus cyclophosphamide after surgery.

Randomized, double-blind, placebo-controlled

American Ginseng for the Prevention of Moderate-severe Fatigue in Breast Cancer Patients

American Ginseng (Panax Quinquefolius) for the Prevention of Moderate-severe Fatigue in Breast Cancer Patients Submitted to Adjuvant Chemotherapy After Surgery. A Study of NICSO (Network Italiano Cure di Supporto in Oncologia).

Incidence will be evaluated through the Numeric Rating Scale (NRS). NRS is a linear numeric scale, from 0 = no fatigue to 10 = the worst possible fatigue. A NRS value ≥ 4 indicates the presence of a signficative fatigue (moderate-severe fatigue).

Intensity will be evaluated through the Numeric Rating Scale (NRS). NRS is a linear numeric scale, from 0 = no fatigue to 10 = the worst possible fatigue. A NRS value ≥ 4 indicates the presence of a signficative fatigue (moderate-severe fatigue).moderate-severe fatigue.

QoL will be evaluated through validated instruments: the Brief Fatigue Inventory (BFI) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30), Italian version.

Azienda Ospedaliera di Perugia

Associazione Umbra per la lotta Contro il Cancro

Avanti Tutta Onlus

Network Italiano Cure di Supporto in Oncologia

Medical doctor

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.

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.

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.

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.

American ginseng

Brent A. Bauer, MD

RATIONALE: American ginseng may help relieve cancer-related fatigue.

PURPOSE: This clinical trial is studying how well American ginseng works in treating patients with cancer-related fatigue.

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.

American Ginseng in Treating Patients With Cancer-Related Fatigue

The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of Ginseng for Patients on Regorafenib	NCT02581059	Colorectal Canc... Palliative Medi... Supportive Care	Regorafenib Ginseng	18 Years -	Hoosier Cancer Research Network
American Ginseng for the Prevention of Moderate-severe Fatigue in Breast Cancer Patients	NCT03730298	Cancer Related ... Breast Cancer F...	American Ginsen... Placebo	18 Years -	Network Italiano Cure di Supporto in Oncologia
Efficacy of Ginseng for Patients on Regorafenib	NCT02581059	Colorectal Canc... Palliative Medi... Supportive Care	Regorafenib Ginseng	18 Years -	Hoosier Cancer Research Network
American Ginseng in Treating Patients With Cancer-Related Fatigue	NCT00182780	Fatigue Unspecified Adu...	American ginsen... Placebo	18 Years -	Alliance for Clinical Trials in Oncology

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