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Quality of Life is Improved in Breast Cancer Patients by Standardised Mistletoe Extract PS76A2 during Chemotherapy and Follow-up: A Randomised, Placebo-controlled, Double-blind, Multicentre Clinical Trial
The objective of this randomised, multicentre, double-blind clinical trial was to investigate the impact of PS76A2, an aqueous mistletoe extract standardised to mistletoe lectins, on quality of life (QoL) in breast cancer patients. A total of 352 patients were randomly allocated to 2 groups receivin...
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Published in: | Anticancer research 2006-03, Vol.26 (2B), p.1519-1529 |
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creator | SEMIGLAZOV, V. F STEPULA, V. V DUDOV, A SCHNITKER, J MENGS, U |
description | The objective of this randomised, multicentre, double-blind clinical trial was to investigate the impact of PS76A2, an aqueous
mistletoe extract standardised to mistletoe lectins, on quality of life (QoL) in breast cancer patients. A total of 352 patients
were randomly allocated to 2 groups receiving PS76A2 (15 ng mistletoe lectin/0.5 ml) or matching placebo twice weekly for
4 to 6 cycles of CMF (cyclophosphamide, methotrexate, fluorouracil) chemotherapy followed by 2 months follow-up. The primary
efficacy end-point was the change from baseline of 3 FACT-G subscales (physical, emotional and functional well-being) during
the fourth CMF cycle. Secondary measures included GLQ-8 (8 linear analogue self-assessment scales), Spitzer's uniscale and
haematological variables. The main variables of safety analysis were adverse events, including injection site reactions and
clinical laboratory tests. The results showed that physical, emotional and functional well-being improved upon PS76A2, but
deteriorated following placebo. The treatment differences were statistically significant for the 3 subscales as well as for
the summary score FACT-G, which was analysed as O'Brien's rank sum of its 3 subscales. The total score increased by 4.40±11.28,
indicating a higher QoL after PS76A2, but decreased by 5.11±11.77 with placebo (p |
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fullrecord | <record><control><sourceid>pubmed_pasca</sourceid><recordid>TN_cdi_pubmed_primary_16619567</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>16619567</sourcerecordid><originalsourceid>FETCH-LOGICAL-h270t-d1bb8ec2f05f2cd2a2d205c3b394e2e67fe7cbd6a6830441bd3944b3d2c999113</originalsourceid><addsrcrecordid>eNpFkN1O3DAQhaOqVdlSXqGam_aKSLazsTe9W1IoSIu6LXAd-WdCXDlxZDuFfcc-VI0A9Wo0Z745OjpvihUVDS1FXZG3xYqwmpSCkPqo-BDjb0I4bzbV--KIck6bmotV8ffnIp1NB_A97GyPYCNcjXPwf9CAneAsoIwJWjlpDLCXyeKUIqgD3CQ5GRmMjZm8tjE5TB7h_DEFqRPsbwTfMjBLsNM9tAOOPg0Y5HyA_AcX3jn_UC7zV9jCr6z48cnoFPZOalS-1H5KIUNP2je_KIelcnbK2_XiktU5RkBos2S1dHAbrHQfi3e9dBFPXuZxcXdxfttelrsf36_a7a4cmCCpNFSpDWrWk7pn2jDJDCO1rlTVrJEhFz0KrQyXfFOR9Zoqkw9rVRmmm6ahtDouPj37zosa0XRzsKMMh-611gx8fgFkzOn6kOuz8T8nuKgF5Zn78swN9n54sAG7OErnsm3VycB4x846WtOm-geiaJH0</addsrcrecordid><sourcetype>Index Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Quality of Life is Improved in Breast Cancer Patients by Standardised Mistletoe Extract PS76A2 during Chemotherapy and Follow-up: A Randomised, Placebo-controlled, Double-blind, Multicentre Clinical Trial</title><source>EZB Electronic Journals Library</source><creator>SEMIGLAZOV, V. F ; STEPULA, V. V ; DUDOV, A ; SCHNITKER, J ; MENGS, U</creator><creatorcontrib>SEMIGLAZOV, V. F ; STEPULA, V. V ; DUDOV, A ; SCHNITKER, J ; MENGS, U</creatorcontrib><description>The objective of this randomised, multicentre, double-blind clinical trial was to investigate the impact of PS76A2, an aqueous
mistletoe extract standardised to mistletoe lectins, on quality of life (QoL) in breast cancer patients. A total of 352 patients
were randomly allocated to 2 groups receiving PS76A2 (15 ng mistletoe lectin/0.5 ml) or matching placebo twice weekly for
4 to 6 cycles of CMF (cyclophosphamide, methotrexate, fluorouracil) chemotherapy followed by 2 months follow-up. The primary
efficacy end-point was the change from baseline of 3 FACT-G subscales (physical, emotional and functional well-being) during
the fourth CMF cycle. Secondary measures included GLQ-8 (8 linear analogue self-assessment scales), Spitzer's uniscale and
haematological variables. The main variables of safety analysis were adverse events, including injection site reactions and
clinical laboratory tests. The results showed that physical, emotional and functional well-being improved upon PS76A2, but
deteriorated following placebo. The treatment differences were statistically significant for the 3 subscales as well as for
the summary score FACT-G, which was analysed as O'Brien's rank sum of its 3 subscales. The total score increased by 4.40±11.28,
indicating a higher QoL after PS76A2, but decreased by 5.11±11.77 with placebo (p<0.0001). The GLQ-8 sum of 8 LASA scales
was analysed as a summary score of GLQ-5 (sum of item nos. 1, 5, 6, 7, 8) and GLQ-3 (sum of item nos. 2, 3, 4). GLQ-5 characterises
typical aspects of QoL, while GLQ-3 consists of 3 side-effects of CMF (feeling sick, numbness or pins and needles, loss of
hair). GLQ-5 decreased by 42.9±125.0 upon PS76A2, indicating an improvement in QoL, but increased by 60.3±94.0 upon placebo
(p<0.0001). GLQ-3 deteriorated in both groups (PS76A2: 13.9±52.4; placebo: 34.5±57.0), but the differences in favour of PS76A2
were, nevertheless, statistically significant (p=0.0007). The total score GLQ-8 improved by 28.9±154.6 after PS76A2 and deteriorated
by 94.8±141.1 after placebo (p<0.0001). Spitzer's uniscale improved by 12.2±30.7 upon PS76A2 and deteriorated by 10.8±26.1
with placebo (p<0.0001). After follow-up without chemotherapy, a significant treatment difference in favour of PS76A2 was
determined by means of FACT-G, GLQ-8 and Spitzer's uniscale. PS76A2 was well tolerated in this trial, with the exception of
slight local reactions in 17.6% of the PS76A2 group. In conclusion, PS76A2 (15 ng mistletoe lectin/0.5 ml twice weekly) was
shown to be safe and effective in improving QoL in breast cancer patients during chemotherapy and follow-up.</description><identifier>ISSN: 0250-7005</identifier><identifier>EISSN: 1791-7530</identifier><identifier>PMID: 16619567</identifier><language>eng</language><publisher>Attiki: International Institute of Anticancer Research</publisher><subject><![CDATA[Adult ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Breast Neoplasms - drug therapy ; Breast Neoplasms - surgery ; Chemotherapy, Adjuvant ; Cyclophosphamide - administration & dosage ; Cyclophosphamide - adverse effects ; Double-Blind Method ; Female ; Fluorouracil - administration & dosage ; Fluorouracil - adverse effects ; Follow-Up Studies ; Humans ; Methotrexate - administration & dosage ; Methotrexate - adverse effects ; Middle Aged ; Placebos ; Plant Preparations - administration & dosage ; Plant Proteins - administration & dosage ; Prospective Studies ; Quality of Life ; Ribosome Inactivating Proteins, Type 2 ; Toxins, Biological - administration & dosage]]></subject><ispartof>Anticancer research, 2006-03, Vol.26 (2B), p.1519-1529</ispartof><rights>2006 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17675716$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16619567$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>SEMIGLAZOV, V. F</creatorcontrib><creatorcontrib>STEPULA, V. V</creatorcontrib><creatorcontrib>DUDOV, A</creatorcontrib><creatorcontrib>SCHNITKER, J</creatorcontrib><creatorcontrib>MENGS, U</creatorcontrib><title>Quality of Life is Improved in Breast Cancer Patients by Standardised Mistletoe Extract PS76A2 during Chemotherapy and Follow-up: A Randomised, Placebo-controlled, Double-blind, Multicentre Clinical Trial</title><title>Anticancer research</title><addtitle>Anticancer Res</addtitle><description>The objective of this randomised, multicentre, double-blind clinical trial was to investigate the impact of PS76A2, an aqueous
mistletoe extract standardised to mistletoe lectins, on quality of life (QoL) in breast cancer patients. A total of 352 patients
were randomly allocated to 2 groups receiving PS76A2 (15 ng mistletoe lectin/0.5 ml) or matching placebo twice weekly for
4 to 6 cycles of CMF (cyclophosphamide, methotrexate, fluorouracil) chemotherapy followed by 2 months follow-up. The primary
efficacy end-point was the change from baseline of 3 FACT-G subscales (physical, emotional and functional well-being) during
the fourth CMF cycle. Secondary measures included GLQ-8 (8 linear analogue self-assessment scales), Spitzer's uniscale and
haematological variables. The main variables of safety analysis were adverse events, including injection site reactions and
clinical laboratory tests. The results showed that physical, emotional and functional well-being improved upon PS76A2, but
deteriorated following placebo. The treatment differences were statistically significant for the 3 subscales as well as for
the summary score FACT-G, which was analysed as O'Brien's rank sum of its 3 subscales. The total score increased by 4.40±11.28,
indicating a higher QoL after PS76A2, but decreased by 5.11±11.77 with placebo (p<0.0001). The GLQ-8 sum of 8 LASA scales
was analysed as a summary score of GLQ-5 (sum of item nos. 1, 5, 6, 7, 8) and GLQ-3 (sum of item nos. 2, 3, 4). GLQ-5 characterises
typical aspects of QoL, while GLQ-3 consists of 3 side-effects of CMF (feeling sick, numbness or pins and needles, loss of
hair). GLQ-5 decreased by 42.9±125.0 upon PS76A2, indicating an improvement in QoL, but increased by 60.3±94.0 upon placebo
(p<0.0001). GLQ-3 deteriorated in both groups (PS76A2: 13.9±52.4; placebo: 34.5±57.0), but the differences in favour of PS76A2
were, nevertheless, statistically significant (p=0.0007). The total score GLQ-8 improved by 28.9±154.6 after PS76A2 and deteriorated
by 94.8±141.1 after placebo (p<0.0001). Spitzer's uniscale improved by 12.2±30.7 upon PS76A2 and deteriorated by 10.8±26.1
with placebo (p<0.0001). After follow-up without chemotherapy, a significant treatment difference in favour of PS76A2 was
determined by means of FACT-G, GLQ-8 and Spitzer's uniscale. PS76A2 was well tolerated in this trial, with the exception of
slight local reactions in 17.6% of the PS76A2 group. In conclusion, PS76A2 (15 ng mistletoe lectin/0.5 ml twice weekly) was
shown to be safe and effective in improving QoL in breast cancer patients during chemotherapy and follow-up.</description><subject>Adult</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - surgery</subject><subject>Chemotherapy, Adjuvant</subject><subject>Cyclophosphamide - administration & dosage</subject><subject>Cyclophosphamide - adverse effects</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Fluorouracil - administration & dosage</subject><subject>Fluorouracil - adverse effects</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Methotrexate - administration & dosage</subject><subject>Methotrexate - adverse effects</subject><subject>Middle Aged</subject><subject>Placebos</subject><subject>Plant Preparations - administration & dosage</subject><subject>Plant Proteins - administration & dosage</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>Ribosome Inactivating Proteins, Type 2</subject><subject>Toxins, Biological - administration & dosage</subject><issn>0250-7005</issn><issn>1791-7530</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><recordid>eNpFkN1O3DAQhaOqVdlSXqGam_aKSLazsTe9W1IoSIu6LXAd-WdCXDlxZDuFfcc-VI0A9Wo0Z745OjpvihUVDS1FXZG3xYqwmpSCkPqo-BDjb0I4bzbV--KIck6bmotV8ffnIp1NB_A97GyPYCNcjXPwf9CAneAsoIwJWjlpDLCXyeKUIqgD3CQ5GRmMjZm8tjE5TB7h_DEFqRPsbwTfMjBLsNM9tAOOPg0Y5HyA_AcX3jn_UC7zV9jCr6z48cnoFPZOalS-1H5KIUNP2je_KIelcnbK2_XiktU5RkBos2S1dHAbrHQfi3e9dBFPXuZxcXdxfttelrsf36_a7a4cmCCpNFSpDWrWk7pn2jDJDCO1rlTVrJEhFz0KrQyXfFOR9Zoqkw9rVRmmm6ahtDouPj37zosa0XRzsKMMh-611gx8fgFkzOn6kOuz8T8nuKgF5Zn78swN9n54sAG7OErnsm3VycB4x846WtOm-geiaJH0</recordid><startdate>20060301</startdate><enddate>20060301</enddate><creator>SEMIGLAZOV, V. F</creator><creator>STEPULA, V. V</creator><creator>DUDOV, A</creator><creator>SCHNITKER, J</creator><creator>MENGS, U</creator><general>International Institute of Anticancer Research</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope></search><sort><creationdate>20060301</creationdate><title>Quality of Life is Improved in Breast Cancer Patients by Standardised Mistletoe Extract PS76A2 during Chemotherapy and Follow-up: A Randomised, Placebo-controlled, Double-blind, Multicentre Clinical Trial</title><author>SEMIGLAZOV, V. F ; STEPULA, V. V ; DUDOV, A ; SCHNITKER, J ; MENGS, U</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-h270t-d1bb8ec2f05f2cd2a2d205c3b394e2e67fe7cbd6a6830441bd3944b3d2c999113</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adult</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - surgery</topic><topic>Chemotherapy, Adjuvant</topic><topic>Cyclophosphamide - administration & dosage</topic><topic>Cyclophosphamide - adverse effects</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Fluorouracil - administration & dosage</topic><topic>Fluorouracil - adverse effects</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Methotrexate - administration & dosage</topic><topic>Methotrexate - adverse effects</topic><topic>Middle Aged</topic><topic>Placebos</topic><topic>Plant Preparations - administration & dosage</topic><topic>Plant Proteins - administration & dosage</topic><topic>Prospective Studies</topic><topic>Quality of Life</topic><topic>Ribosome Inactivating Proteins, Type 2</topic><topic>Toxins, Biological - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>SEMIGLAZOV, V. F</creatorcontrib><creatorcontrib>STEPULA, V. V</creatorcontrib><creatorcontrib>DUDOV, A</creatorcontrib><creatorcontrib>SCHNITKER, J</creatorcontrib><creatorcontrib>MENGS, U</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>Anticancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>SEMIGLAZOV, V. F</au><au>STEPULA, V. V</au><au>DUDOV, A</au><au>SCHNITKER, J</au><au>MENGS, U</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Quality of Life is Improved in Breast Cancer Patients by Standardised Mistletoe Extract PS76A2 during Chemotherapy and Follow-up: A Randomised, Placebo-controlled, Double-blind, Multicentre Clinical Trial</atitle><jtitle>Anticancer research</jtitle><addtitle>Anticancer Res</addtitle><date>2006-03-01</date><risdate>2006</risdate><volume>26</volume><issue>2B</issue><spage>1519</spage><epage>1529</epage><pages>1519-1529</pages><issn>0250-7005</issn><eissn>1791-7530</eissn><abstract>The objective of this randomised, multicentre, double-blind clinical trial was to investigate the impact of PS76A2, an aqueous
mistletoe extract standardised to mistletoe lectins, on quality of life (QoL) in breast cancer patients. A total of 352 patients
were randomly allocated to 2 groups receiving PS76A2 (15 ng mistletoe lectin/0.5 ml) or matching placebo twice weekly for
4 to 6 cycles of CMF (cyclophosphamide, methotrexate, fluorouracil) chemotherapy followed by 2 months follow-up. The primary
efficacy end-point was the change from baseline of 3 FACT-G subscales (physical, emotional and functional well-being) during
the fourth CMF cycle. Secondary measures included GLQ-8 (8 linear analogue self-assessment scales), Spitzer's uniscale and
haematological variables. The main variables of safety analysis were adverse events, including injection site reactions and
clinical laboratory tests. The results showed that physical, emotional and functional well-being improved upon PS76A2, but
deteriorated following placebo. The treatment differences were statistically significant for the 3 subscales as well as for
the summary score FACT-G, which was analysed as O'Brien's rank sum of its 3 subscales. The total score increased by 4.40±11.28,
indicating a higher QoL after PS76A2, but decreased by 5.11±11.77 with placebo (p<0.0001). The GLQ-8 sum of 8 LASA scales
was analysed as a summary score of GLQ-5 (sum of item nos. 1, 5, 6, 7, 8) and GLQ-3 (sum of item nos. 2, 3, 4). GLQ-5 characterises
typical aspects of QoL, while GLQ-3 consists of 3 side-effects of CMF (feeling sick, numbness or pins and needles, loss of
hair). GLQ-5 decreased by 42.9±125.0 upon PS76A2, indicating an improvement in QoL, but increased by 60.3±94.0 upon placebo
(p<0.0001). GLQ-3 deteriorated in both groups (PS76A2: 13.9±52.4; placebo: 34.5±57.0), but the differences in favour of PS76A2
were, nevertheless, statistically significant (p=0.0007). The total score GLQ-8 improved by 28.9±154.6 after PS76A2 and deteriorated
by 94.8±141.1 after placebo (p<0.0001). Spitzer's uniscale improved by 12.2±30.7 upon PS76A2 and deteriorated by 10.8±26.1
with placebo (p<0.0001). After follow-up without chemotherapy, a significant treatment difference in favour of PS76A2 was
determined by means of FACT-G, GLQ-8 and Spitzer's uniscale. PS76A2 was well tolerated in this trial, with the exception of
slight local reactions in 17.6% of the PS76A2 group. In conclusion, PS76A2 (15 ng mistletoe lectin/0.5 ml twice weekly) was
shown to be safe and effective in improving QoL in breast cancer patients during chemotherapy and follow-up.</abstract><cop>Attiki</cop><pub>International Institute of Anticancer Research</pub><pmid>16619567</pmid><tpages>11</tpages></addata></record> |
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subjects | Adult Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Breast Neoplasms - drug therapy Breast Neoplasms - surgery Chemotherapy, Adjuvant Cyclophosphamide - administration & dosage Cyclophosphamide - adverse effects Double-Blind Method Female Fluorouracil - administration & dosage Fluorouracil - adverse effects Follow-Up Studies Humans Methotrexate - administration & dosage Methotrexate - adverse effects Middle Aged Placebos Plant Preparations - administration & dosage Plant Proteins - administration & dosage Prospective Studies Quality of Life Ribosome Inactivating Proteins, Type 2 Toxins, Biological - administration & dosage |
title | Quality of Life is Improved in Breast Cancer Patients by Standardised Mistletoe Extract PS76A2 during Chemotherapy and Follow-up: A Randomised, Placebo-controlled, Double-blind, Multicentre Clinical Trial |
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