RCT With Adjuvant Mistletoe Treatment in Gastric Cancer Patients

Gastric Cancer Clinical Trial

Official title:

Prospective Controlled Randomized Comparative Study About Quality of Life (QoL), Immunomodulation and Safety of Adjuvant Mistletoe Treatment in Patients With Gastric Carcinoma Receiving Chemotherapy After Operation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401075
• Other study ID #: AB-AVQ20-1.0
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2011
• Last updated: November 6, 2012
• Start date: March 2006
• Est. completion date: April 2008

Study information

• Verified date: July 2011
• Source: Abnoba Gmbh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Evaluation of safety and efficacy of a standardized mistletoe extract (abnobaVISCUM® Quercus, aVQ) in patients with gastric cancer receiving oral chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• postoperative UICC stage Ib/II gastric carcinoma

• indication for oral chemotherapy with doxifluridine

• ECOG performance status 0 or 1

• normal liver and kidney function

Exclusion Criteria:

• inability to answer the QoL scales

• concomitant therapy with steroids or biological response modifiers

• individual hypersensitivity to mistletoe preparations

• pregnancy or lactating

• participation in another clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• mistletoe extract
subcutaneous injections thrice weekly with 1 ml in 4 increasing doses
• doxifluridine
600 - 900 mg per day orally, depending on weight and status of the patient

Locations

Country	Name	City	State
Korea, Republic of	ASAN Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Abnoba Gmbh

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Kim KC, Yook JH, Eisenbraun J, Kim BS, Huber R. Quality of life, immunomodulation and safety of adjuvant mistletoe treatment in patients with gastric carcinoma - a randomized, controlled pilot study. BMC Complement Altern Med. 2012 Oct 3;12:172. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	EORTC Quality of Life Questionnaires: QLQ-C30; QLQ-STO22	24 weeks	No
Secondary	Immunomodulation	cytokine levels (TNF-alpha and interleukin-2); lymphocyte subsets (CD 16+/CD56+ and CD 19+)	24 weeks	No
Secondary	Safety and tolerability	differential blood count; liver functions tests; adverse events	24 weeks	Yes