None listed
Conditions
Brief summary
This study looks at the safety and tolerability of the traditional chinese medicine formulation GOPAC in patients with advanced malignancy. Who is it for? You can join the study if you have cancer which has recurred or spread to distant sites and you are not currently receiving chemotherapy. Trial details: Participants will all receive GOPAC capsules for 6 weeks. Each week they will be monitored with questionnaires, blood tests and measurement of any toxic response. GOPAC is a traditional chinese herbal medicine formulation consisting of 5 herbs in a capsule formulation. It has few reported side effects.
Interventions
"GOPAC" is a traditional chinese herbal medicine proprietary formulation consisting of 5 herbs in a capsule formulation.
It is administered as a combination of 2 oral capsules:
1. "Clone of Concord Sunchih GOPAC" (Ganoderma lucidum 140mg spore & 100mg extract; Agrimonia eupatoria 75mg; Patrinia scabiosaefolia 75mg; Hedyotis diffusa 100mg; Cordyceps sinensis 10mg)
2. "Concord Vita-cordy"
(Cordyceps sinensis 400mg)
Duration of supplement: 6 wks
Mode Of Administration (MOA): oral capsule
Dose (d
"GOPAC" is a traditional chinese herbal medicine proprietary formulation consisting of 5 herbs in a capsule formulation. It is administered as a combination of 2 oral capsules: 1. "Clone of Concord Sunchih GOPAC" (Ganoderma lucidum 140mg spore & 100mg extract; Agrimonia eupatoria 75mg; Patrinia scabiosaefolia 75mg; Hedyotis diffusa 100mg; Cordyceps sinensis 10mg) 2. "Concord Vita-cordy" (Cordyceps sinensis 400mg) Duration of supplement: 6 wks Mode Of Administration (MOA): oral capsule Dose (dose escalation study): 1. Cohort 1: 2 capsules each three times a day (TDS) 2. Cohort 2: 3 capsules each TDS 3. Cohort 3: 4 capsules each TDS
Sponsors
Sydney South West Area Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active malignancy (recurrent or metastatic) * can swallow capsules WHOLE * Fluent english or chinese * not currently receiving chemotherapy
Exclusion criteria
Inadequate organ function Allergy to study ingredients (esp. mushrooms) Eastern Cooperative Oncology performance group (ECOG PS) > 3 Concurrent radiotherapy Major comorbidities
Outcome results
None listed